Simufilam results. Following this news .

Simufilam results Over 1,900 Patients with Alzheimer’s Disease Are Randomized in Phase 3 Trials of Simufilam. 0 Million in Cash and Cash Equivalents at September 30, 2024. SAVA stock plunged Monday after the company released topline data from the Phase 3 ReThink-ALZ study of simufilam in mild-to-moderate Alzheimer’s disease. This site is intended for healthcare professionals The topline results from the Phase 3 ReThink-ALZ study of simufilam in mild-to-moderate AD did not meet each of the pre-specified co-primary, secondary and exploratory biomarker endpoints. This latest disappointing news came in the form of a company press release, which noted that “the topline results from the Phase 3 ReThink-ALZ study of simufilam in mild-to-moderate AD did not --Cassava Sciences, Inc. Nov. Results: mTOR was overactive and its response to insulin reduced in lymphocytes from AD versus healthy control subjects, illustrating another aspect of insulin resistance in AD. Securities and Exchange Commission (SEC) over allegedly misleading statements about the results of its 2020 mid-stage study of simufilam for AD. The S. Simufilam’s controversial development primed people to suspect a failure but the stock still fell Simufilam in clinical trials. including full phase 2/3 results of Anavex Life The study evaluated changes in cognition and function over 52 weeks using ADAS-COG12 and ADCS-ADL scales. AUSTIN, Texas, May 10, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. Why: The SEC argued Cassava made misleading statements about phase two clinical trial results for its potential Alzheimer’s disease therapeutic PTI-125, also known as On November 25, 2024, Cassava released topline results for the first of its two ongoing Phase 3 studies on simufilam, the "ReThink-ALZ" study. AUSTIN, Texas , Jan. By Teddy Rosenbluth. The results showed it was safe and well tolerated. , and from British Columbia to Nova Scotia in Canada, and participants have the option to select their nearest among the many available. “If the studies were to, by some chance, have a positive outcome, nobody in their right mind could trust AUSTIN, Texas, Nov. Simufilam is a small molecule drug targeting the altered form of filamin A found in the AD brain to restore its normal shape and function. This site is Simufilam OLS Results The market is irrationally responding to the OLS results recently published by Cassava, in my opinion. • The academic journals which published the studies discussed herein should review Cassava settlement overview: Who: Clinical-stage biopharmaceutical company Cassava Sciences agreed to pay more than $40 million to end U. 3 The results indicated that simufilam failed to meet each of the pre-specified primary, secondary, and exploratory endpoints; in sum, simufilam failed to outperform the placebo. This She joins our company at a critical time, ahead of the release of topline results from RETHINK-ALZ, our first Phase 3 trial for simufilam, expected by the end of 2024, and potential product launch On November 25, 2024, Cassava released topline results for the first of its two ongoing Phase 3 studies on simufilam, the “ReThink-ALZ” study. 1. C. In a double-blind, randomized, placebo-controlled Phase 2b study, simufilam demonstrated robust effects on primary and secondary outcome The simufilam results are one of the latest setbacks for Cassava. It uses the same gold standard method for AD drugs making this comparison valid. At March 31, 2024, cash and cash equivalents were $124. 40. In July, a Department of Justice criminal investigation was revealed by Results: mTOR was overactive and its response to insulin reduced in lymphocytes from AD versus healthy control subjects, illustrating another aspect of insulin resistance in AD. 7 points. If accurate, the simufilam results are relatively impressive, but other treatments that act as direct antioxidants Cassava Sciences Inc. The US Securities and Exchange Commission (SEC) set out a case against the Texas-based company and two former executives, founder and former CEO, Remi Barbier, and the former Senior Cassava's Phase 3 clinical trials for Alzheimer's drug simufilam continue, despite doubts raised about data integrity and potential falsification by Dr. The trial did not On November 25, 2024, Cassava released topline results for the first of its two ongoing Phase 3 studies on simufilam, the "ReThink-ALZ" study. Top-line results for on-going, 52-week Phase 3 trial expected approximately year-end 2024. (Nasdaq: SAVA), a biotechnology company, today announced positive top-line Phase 2 results for simufilam, its oral drug Jul 6, 2023 · US-based Cassava Sciences has announced that oral therapy simufilam slowed cognitive decline by 38% versus placebo over six months in patients with mild to moderate Alzheimer’s disease in a Phase II study. The company reported approximately $149. AUSTIN, Texas, Feb. Simufilam continued to show an overall favorable safety profile, however. 25, 2024. Drug Effects Favored Mild Alzheimer’s Disease. Previous interim safety reviews of both trials indicated no relevant safety issues. Simufilam improved cognition and behavior in people with Alzheimer's disease after six months of dosing in a clinical trial, data show. Both are AUSTIN, Texas, Jan. Over 200 patients with mild-to-moderate Alzheimer’s were treated for a year. (AD) dementia, today announced that the topline results from the Phase 3 ReThink-ALZ study of simufilam in mild-to-moderate AD did not meet each of the pre-specified co-primary, secondary and exploratory biomarker endpoints. , a biotechnology company focused on Alzheimer’ s disease, today announced the completion of a third interim safety review of simufilam in on-going Phase 3 clinical 1,929 patients randomized in a pair of Phase 3 trials to evaluate oral simufilam in Alzheimer's disease dementia. Results of a Phase 2 Randomized Withdrawal Study of Simufilam in Mild Pending positive simufilam Phase 3 results and FDA approval, we believe Freda’s extensive expertise will be invaluable to the development of a robust commercial plan. After oral simufilam, lymphocytes showed HC Wainwright analyst anticipates that the results from these clinical trials will show simufilam’s potential to be the first drug to sustainably alter disease progression over a six-month Study locations span from Florida to Washington in the U. Simufilam Significantly Improved Biomarkers in Alzheimer’s Patients Treated for 6 MonthsRobust Improvements Seen in All Measured Biomarkers of Disease, Neurodegeneration and Neuroinflammation (p . 5 points, making it a 8. Cassava Sciences has discontinued the ReFocus-ALZ trial due to disappointing results from ReThink-ALZ. Due to these disappointing results, the company is discontinuing its second Phase 3 trial, ReFocus-ALZ, and the Open Label Extension study. S. The study enrolled over 200 patients with mild-to-moderate Alzheimer’s disease (MMSE 16-26). Net income was $25. (Nasdaq: SAVA), a biotechnology company focused on a novel treatment for Alzheimer’s disease, today reported financial She joins our company at a critical time, ahead of the release of topline results from RETHINK-ALZ, our first Phase 3 trial for simufilam, expected by the end of 2024, and potential product launch,&CloseCurlyDoubleQuote; said Rick Barry, President and Chief Executive Officer. This time, simufilam sharply reduced tau, beta amyloid, and other biomarkers. (Nasdaq: SAVA), a biotechnology company, today announced positive top-line Phase 2 results for simufilam, its oral drug candidate for Alzheimer s disease dementia. Also: a Roche lung cancer drug has failed to improve survival; pharma companies' net zero carbon goals; and more. Initiation of a Phase 3 trial remains on Cassava Sciences, Inc announced that the topline results from the Phase III ReThink-ALZ study of simufilam in mild-to-moderate AD did not meet each of the pre-specified co-primary, secondary and exploratory biomarker endpoints. A presentation from Suzanne $207. Results from the interim analysis showed improvements in cognition and behavior scores after six months of treatment with simulfilam. Top-line results for on-going, 76-week Phase 3 trial expected approximately mid-year 2025. SAVA stock is still worth over $900 given the positive 9-mo results of Simufilam. the interim safety status or profile of simufilam to date in our Phase 3 clinical studies; Simufilam has been eagerly anticipated by patients and families, and fervidly supported by a group of investors. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that may include • The FDA should audit all clinical biomarker studies of simufilam in AD. In Nov 25, 2024 · Simufilam did not show a significant reduction in cognitive or functional decline versus placebo in patients with mild-to-moderate Alzheimer’s disease in the ReThink-ALZ Mar 14, 2023 · That’s according to top-line data from the open-label Phase 2 study (NCT04388254) in 216 people with mild-to-moderate disease, treated with simufilam tablets at 100 mg twice daily for a year. . Feb 8, 2024 · Two Phase 3 clinical trials are testing the effectiveness of simufilam, an experimental oral therapy that’s designed to improve cognition in people with Alzheimer’s Apr 18, 2022 · In November 2021, the company disclosed that it is the target of an SEC investigation into claims that it manipulated research results on simufilam (WSJ article). As the company prepares to release trial results, Ben Hargreaves finds that Results: mTOR was overactive and its response to insulin reduced in lymphocytes from AD versus healthy control subjects, illustrating another aspect of insulin resistance in AD. The DSMB Recommended Both Phase 3 Trials The authors expect the clinical results of the Phase III trial of Simufilam to be deceiving, leading to a sharp decline in the stock price of SAVA-from which the authors would profit financially. 2 improvement in ADAS-cog scores over baseline at one year. 3 Million in Cash and Cash Equivalents at June 30, 2024. Company in Advanced Discussions to Resolve SEC Investigation. T2 and DWI sequences. The results indicated that simufilam failed to meet each of the pre-specified primary, secondary, and exploratory endpoints. also charged a Cassava The investigational, oral small molecule treatment for Alzheimer disease (AD), simufilam, has shown in the results of an open-label study to be associated with the improvement of cognition and behavior in individuals with AD without any reported safety issues. September 22, 2021, 8:30 am Cognition Scores Cassava Sciences (SAVA) announced positive top-line results from a Phase 2 study of simufilam, an oral treatment for Alzheimer’s disease. E. I've seen criticisms on Twitter range from attacking the legal verbage used to cover their bases (regarding audits, interpretations of data, etc. • Alzheimer’s pathology: Amyloid β 42, Total Tau and P-tau181 • Neurodegeneration: Neurogranin and Neurofilament Light Chain (NfL) • Neuroinflammation: YKL-40, soluble TREM2 and HMGB1 •CSF was collected by lumbar Simufilam: a 3. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today reported financial results for first quarter ended March 31, 2024. According to the SEC charges, the final results presented by Cassava were misleading in five Simufilam did not show a significant reduction in cognitive or functional decline versus placebo in patients with mild-to-moderate Alzheimer’s disease in the ReThink-ALZ Phase 3 study Simufilam Pending positive simufilam Phase 3 results and FDA approval, we believe Freda’s extensive expertise will be invaluable to the development of a robust commercial plan. The company has decided to discontinue a second Phase 3 trial because of Monday's results, he said, but will report Topline data from Phase 3 REFOCUS-ALZ study of simufilam in patients with mild-to-moderate Alzheimer’s disease expected late first-quarter/early second-quarter 2025 Implementing cost curtailment including a workforce reduction of approximately 33% Approximately $128. Cassava Sciences Inc. See why SAVA stock is a Hold. With its Q3 2024 results early this month Pending positive simufilam Phase 3 results and FDA approval, we believe Freda’s extensive expertise will be invaluable to the development of a robust commercial plan. An open-label Phase 2a clinical trial (NCT03748706), which wrapped up in 2019, investigated the safety and Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company, today reported top-line results of a two-year clinical safety study of simufilam $126. The Cognition Maintenance Study (CMS) is a 6-month, Randomized Controlled Trial of Simufilam in Over 125 Patients with Alzheimer’s Disease. ReThink-ALZ was a double-blinded study that randomly assigned 804 patients with confirmed mild or moderate AD to either simufilam 100 mg (n = 403) or a matched placebo (n = 401), dosed orally twice daily (BID Over 735 Patients Have Completed a Phase 3 Trial of Simufilam. In its interim report, Cassava said that simufilam improved cognition scores and decreased dementia-related behaviors such as anxiety, delusions and New cell biology data from Europe shows simufilam interrupts a pathogenic signaling pathway in Alzheimer’s disease. The clinical data for simufilam will detail the results of “an interim analysis on safety and cognition for the first 50 patients with Alzheimer’s disease to complete 9 months of open-label Based on the above study results, Cassava also decided to discontinue the phase III ReFocus-ALZ study, which evaluated simufilam in AD patients over a 76-week period. Cassava Sciences ha annunciato che il suo studio di Fase 3 Co-Primary Endpoint Data* Simufilam 100 mg BID N= 403: Placebo BID N=401: Delta: P-value: Co-Primary Endpoints LS means change from baseline to the end of the double-blind treatment period The Alzheimer’s drug simufilam was the company’s only drug in clinical trials. Aber, warum ist Simufilam nicht der Durchbruch, den die Pressemitteilung vermuten lässt? CSF Biomarkers •Biomarkers of disease were measured in a subset of subjects (N=25) who completed 6 months of simufilam treatment. Securities and Exchange Im Juli 2021 gab Cassava Sciences bekannt, das Medikament Simufilam verbessere die kognitiven Fähigkeiten von Patienten mit der Alzheimer-Erkrankung 1. Primary Outcome Measures Are Simufilam restores FLNA’s normal shape to disrupt its AD-associated protein interactions. She will play a key role in In November 2024, Cassava reported that the topline results from the Phase 3 RETHINK-ALZ study evaluating simufilam as a potential treatment for patients with mild-to-moderate Alzheimer’s This news release contains forward-looking statements that include but are not limited to statements regarding: the completion and future results of our Phase 3 clinical studies of simufilam in Simufilam did not show a significant reduction in cognitive or functional decline versus placebo in patients with mild-to-moderate Alzheimer’s disease in the ReThink-ALZ Phase 3 study In September, Cassava paid a penalty of $40 million after the SEC's investigation into the company's misleading claims regarding the results of its 2020 Phase 2b clinical trial of simufilam. $40 Million Estimated Loss Cassava reported positive top line mid-stage data in 2023 suggesting simufilam “slowed cognitive decline” by 38% compared to a placebo in mild to moderate Alzheimer’s. It will also be discontinuing Well, results of the two-year clinical trial showed that patients with mild Alzheimer’s who took Simufilam continuously showed no decline in cognitive test scores as a group. The simufilam results are one of the latest setbacks for Cassava. 07, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. STATEMENTS OF GROUNDS:Top-line Results of 12-month Interim Analysis from Open-label Study Evaluating Simufilam in Alzheimer’s Disease Cassava Sciences, Inc. (NASDAQ:SAVA) stock plunged Monday after the company released topline data from the Phase 3 ReThink-ALZ study of simufilam in mild-to-moderate Alzheimer’s disease. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Cassava Sciences Inc. The effect of simufilam on Aβ 42 binding to α7nAChR was determined by a TR-FRET assay, which relies on the excitation of Aβ 42-FAM (donor fluorophore) to produce an energy transfer to SNAP-α7nAChR (acceptor fluorophore) if they are in close proximity (<10 nm; Förster radius). 7 point difference. Here are some key points to consider: Risk/Reward Analysis : Despite the impressive safety data, the risk of failure in late-stage trials is high, given the historical difficulties in developing effective Alzheimer's treatments. After oral simufilam, lymphocytes showed normalized basal mTOR activity and improved insulin-evoked mTOR activation in mTOR complex 1, complex 2, and upstream and Neither result was statistically significant, with the p values coming in at 0. Wang. ” Cassava has received a total of $13 million in grants from the National Institute on Aging to study simufilam. She will play a key role in The SEC’s charges relate to statements made by Casava regarding the results of its 2020 Phase 2b clinical trial of simufilam. Approve Phase 4 trials of the drug Simufilam 21 pursuant U. 5 5 Introduction to Simufilam Simufilam, a small molecule agent targeting an altered form of filamen A (FLNA), has been in development for several years, with its first phase 1 study dating to 2017. The company offered better news from a 28-day study of 64 Alzheimer’s patients, including a group given a placebo. • Alzheimer’s pathology: Amyloid β 42, Total Tau and P-tau181 • Neurodegeneration: Neurogranin and Neurofilament Light Chain (NfL) • Neuroinflammation: YKL-40, soluble TREM2 and HMGB1 •CSF was collected by lumbar 2. alleging that the company had made misleading statements about the results of clinical trial data. Results corroborate prior research from other academic researchers. But Schrag’s evaluation of Cassava’s clinical results along with the SEC’s claims of misconduct mean the phase 3 program was built on “tampered” data, he said. At 9 months, ADAS-Cog11 scores improved by -3. Simufilam, previously known as PTI-125, is a small molecule designed to restore the normal shape and function of an altered form of a protein called filamin Cassava Sciences said it will stop all trials of its Alzheimer's disease drug after it failed a late-stage study, sending shares of the drug developer plummeting 83% in early trading on Monday. S&P’s $18 Trillion Rally Threatened by Psychology of 5% Yields (Bloomberg) -- For years it’s seemed like nothing could stop the stock market’s inexorable march higher, as the S&P 500 Index Final Clinical Safety Data for Simufilam Are Expected at the Conclusion of the Phase 3 Program. Simufilam Slowed Cognitive Decline by 38% Versus Placebo Over 6 months in Patients with Mild-to-Moderate Alzheimer’s Disease. Top-line results for on-going, 52-week Phase 3 trial expected approximately year AUSTIN, Texas, Aug. Results showed that most of In November 2024, Cassava reported that the topline results from the Phase 3 RETHINK-ALZ study evaluating simufilam as a potential treatment for patients with mild-to-moderate Alzheimer’s disease did not meet its prespecified co-primary endpoints and that the Company intended to share a detailed analysis of data from the study at a future But advanced trials of simufilam are still underway. Simufilam maintained a favorable safety profile throughout the trial. announced positive top-line Phase II results for simufilam, its oral drug candidate for Alzheimer’s disease dementia. (NASDAQ: SAVA, “Cassava”, the “Company”), a clinical-stage biotechnology company focused on developing a novel, investigational treatment for Alzheimer’s disease (AD) dementia, today announced that the topline results from the Phase 3 ReThink-ALZ study of simufilam in mild-to Simufilam was safe and well-tolerated, consistent with prior safety results. Publication requires complainants to disclose financial conflicts in the wake of controversy over Cassava Sciences’ experimental treatment simufilam. This site is intended for healthcare professionals . Simufilam continued to demonstrate an overall favorable safety profile today announced that the topline results from the Phase 3 ReThink-ALZ study of simufilam in mild-to-moderate AD did not Top-line Data for RETHINK-ALZ 52-week Phase 3 trial Expected Before the End of 2024 $149. 2 million, with no debt. Reduces neurodegeneration Jan 5, 2021 · We are developing simufilam, a proprietary drug candidate to treat Alzheimer's disease, and SavaDx, a blood-based diagnostic to detect Alzheimer’s disease. Following this news, the price of Cassava’s common stock declined Cassava Sciences (SAVA) stock gains as company completes Phase 3 trial for Alzheimer's candidate simufilam, to release topline data by end of 2024. 24, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. • Published preclinical data and mechanism of action studies support simufilam’s potential as a disease-modifying drug for AD that also provides symptomatic improvement. 0 million compared This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to: the design, scope, conduct or intended purpose of our two-year, open-label study or Phase 3 program of simufilam in patients with Alzheimer’s disease; the The results indicated that simufilam failed to meet each of the pre-specified primary, secondary, and exploratory endpoints; in sum, simufilam failed to outperform the placebo. Results 2. She will play a key role in This news release contains forward-looking statements that include but are not limited to statements regarding: the completion and future results of our Phase 3 clinical studies of simufilam in patients with Alzheimer's disease; the planned discontinuation of the ReFocus-ALZ and open-label extension studies; our intent to share detailed study Cassava is advancing simufilam through a pivotal phase 3 trial, despite lingering controversy from a SEC investigation. The Cassava Sciences story ended Monday exactly as many knew it would — with the company’s experimental drug for Alzheimer’s disease, simufilam, failing a clinical trial. 0 points, a 19% mean improvement from baseline. $126. The results indicated that simufilam failed to meet each of the pre-specified primary, secondary, and exploratory endpoints; in sum, simufilam failed to outperform the placebo. This was an open-label safety study with exploratory efficacy endpoints. Cassava Sciences' stock is highly shorted, with potential reward tied to the upcoming Phase 3 trial results for simufilam. party reanalysis of all clinical biomarker studies of simufilam in AD. reported top-line results of a two-year clinical safety study of simufilam, an investigational oral drug for the proposed treatment of Alzheimer’s disease dementia. Further, the treatment was not associated with brain swelling due to amyloid Feb 3, 2022 · Simufilam is our proprietary, small molecule (oral) drug candidate to treat Alzheimer’s disease (AD) and other neurodegenerative diseases. Simufilam treatment improved CSF biomarkers in an open-label phase 2a study in Alzheimer’s patients, but the phase 2b trial failed to meet its primary endpoint. The company reported This news release contains forward-looking statements that include but are not limited to statements regarding: the completion and future results of our Phase 3 clinical studies of simufilam in In November 2024, Cassava reported that the topline results from the Phase 3 RETHINK-ALZ study evaluating simufilam as a potential treatment for patients with mild-to-moderate Alzheimer’s •Simufilam binds a single target, has a dual mechanism of action: • Reduces neurodegeneration and neuroinflammation. 25, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. 43 and 0. Results showed no significant reduction in cognitive or functional decline with simufilam when compared A small biotech company that trumpeted an exciting new treatment for Alzheimer’s disease is now under fire for irregularities in its research results, after several studies related to its work The market projection for simufilam is highly uncertain due to the recent negative results and ongoing challenges. Earlier in September, management agreed to pay a fine of $40 million to settle charges from the U. I recommend that you review the results for yourself. Cassava Sciences stock has been hammered for no good reason. 6 points on ADAS-Cog11, a 10% mean improvement from baseline (negative score indicates improvement). (Nasdaq: SAVA), a biotechnology company, today announced positive top-line Phase 2 results for simufilam, its oral drug Simufilam did not meet primary, secondary, or exploratory endpoints in the ReThink-ALZ phase 3 study for Alzheimer's disease. 31, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. Rigorous The company is currently conducting two phase three trials of simufilam, with results expected by the end of the year. Code § 356 - Expedited approval of drugs for serious or life-threatening diseases or conditions. For simufilam however, you have the Aduhelm placebo data to compare. The second Phase 3 trial (NCT05026177) has a 76-week treatment period; 1,125 Alzheimer’s patients were randomized into this trial. 6 million cash and cash Cassava Sciences Reports Q3 2024 Financial On 29 July, the biopharmaceutical company Cassava Sciences announced positive results from an interim analysis of its open-label study of simufilam in Alzheimer’s disease (AD). In November 2024, Cassava reported that the topline results from the Phase 3 RETHINK-ALZ study evaluating simufilam as a potential treatment for patients with mild-to-moderate Alzheimer’s The company's future now appears to be in flux, as simufilam was its only drug in clinical trials, The New York Times reported. The co Topline results from the phase 3 ReThink-ALZ study of simufilam in mild to moderate Alzheimer’s disease showed the investigational therapeutic did not meet any of its prespecified endpoints. The Austin, Texas-based biotech revealed that simufilam failed its AUSTIN, Texas, Jan. After oral simufilam, lymphocytes showed normalized basal mTOR activity Simufilam was safe, well tolerated. The Dec 3, 2024 · Topline results from the phase 3 ReThink-ALZ study of simufilam in mild to moderate Alzheimer’s disease showed the investigational therapeutic did not meet any of its In November 2024, Cassava reported that the topline results from the Phase 3 RETHINK-ALZ study evaluating simufilam as a potential treatment for patients with mild-to-moderate Alzheimer’s disease did not meet its prespecified co-primary endpoints and that the Company intended to share a detailed analysis of data from the study at a future Data results from our open-label safety study do not constitute, and should not be interpreted as, regulatory evidence of safety or efficacy for simufilam in Alzheimer’s disease. A minimal decline in Sep 26, 2024 · Results from the REFOCUS-ALZ trial are expected by mid-2025. Cassava’s stock soared after each round of reported results from its trials On November 25, 2024, Cassava released topline results for the first of its two ongoing Phase 3 studies on simufilam, the "ReThink-ALZ" study. is facing significant turbulence following the announcement of grim results from its Phase 3 trial of simufilam, the company’s experimental drug aimed at treating Alzheimer’s disease. (Nasdaq: SAVA), a biotechnology company, today reported top-line results of a two-year clinical safety study of simufilam Data results from our open-label safety study do not constitute, and should not be interpreted as, regulatory evidence of safety or efficacy for simufilam in Alzheimer’s disease. Primary Outcome Measures Are Safety and Change in Over the past year, Cassava has fought back against allegations that the company manipulated research results for simufilam. Phase 3 Trials – Our first Phase 3 study, RETHINK-ALZ (NCT04994483), is designed to evaluate the safety and efficacy of simufilam 100 mg tablets administered twice-daily versus matching placebo Simufilam is an investigational oral small molecule that targets the filamin A protein. On this news, the An Independent Data and Safety Monitoring Board (DSMB) Recently Evaluated the Interim Patient Safety Database for Oral Simufilam in On-going Phase 3 Trials. Key findings include:47% of participants improved on the ADAS-Cog scale, with an average improvement of 4. Six months of treatment improved patients’ cognition scores by -1. After oral simufilam, lymphocytes showed normalized basal mTOR activity and improved insulin-evoked mTOR activation in mTOR complex 1, complex 2, and upstream and Cassava Sciences, Inc. After releasing the data on Monday, the company’s stock price plummeted by over 80%, indicative of the devastation felt by both Data results from our open-label study does not constitute, and should not be interpreted as, clinical evidence of therapeutic safety or benefit for simufilam. The EOP2 meeting discussion was supported by years of scientific and clinical data, including positive results from a previously completed Phase 2 clinical program with simufilam in Alzheimer’s disease. 0 million in cash and cash equivalents as of Q3 2024. The results indicated that simufilam failed to meet As a result of these findings, the company has decided to discontinue its second phase 3 study of simufilam, ReFocus-ALZ (NCT05026177). At 9 months, Cassava Sciences' troubled development of Alzheimer's disease candidate simufilam looks like it may have finally reached the end. Despite settling, SAVA did not Results: mTOR was overactive and its response to insulin reduced in lymphocytes from AD versus healthy control subjects, illustrating another aspect of insulin resistance in AD. Securities and Exchange Commission claims. The company’s founder and ex-CEO, Remi Barbier, and Lindsay Burns Cassava Sciences, Inc. , a biotechnology company focused on Alzheimer’ s disease, today reported financial results for first quarter ended March 31, 2024. A Phase 1 clinical trial (NCT03784300) involving healthy volunteers, completed in 2018, evaluated simufilam’s safety and pharmacokinetics, or its movement in the body. “Freda brings to Cassava a proven track record of successfully Prior Results Top-line results of the 6-month On-going Phase 3 Studies of Simufilam in Alzheimer’s Disease Cassava Sciences is evaluating oral simufilam for Alzheimer’s disease dementia in Cassava Sciences is moving forward with Phase III trials after paying $40m to settle an SEC case alleging misleading data from its Phase IIb trial of simufilam. 3 Million In Total Gross Proceeds from Warrant Distribution. Following this news An Independent Data and Safety Monitoring Board (DSMB) Recently Evaluated the Interim Patient Safety Database for Oral Simufilam in On-going Phase 3 Trials. "Freda brings to Cassava a proven track record of successfully developing and The case centers on the publication of data on PTI-125, also known as simufilam, in September 2020. Credit Ilana Panich-Linsman for The New York Times. • The FDA should oversee 3. Cassava Sciences, Inc. Simufilam Reduced Aβ 42 Binding to α7nAChR. rd. 08, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. It is not the final results and it is not a blinded, placebo-controlled trial. Following this news Cassava Sciences, Inc announced that the topline results from the Phase III ReThink-ALZ study of simufilam in mild-to-moderate AD did not meet each of the pre-specified co-primary, secondary and exploratory biomarker endpoints. ) to results being weaker compared to the first set of OLS results to 1,929 patients randomized in a pair of Phase 3 trials to evaluate oral simufilam in Alzheimer's disease dementia. The US Department of Justice has opened a criminal investigation into whether Cassava Sciences, the company developing simufilam, has manipulated research results. The She joins our company at a critical time, ahead of the release of topline results from RETHINK-ALZ, our first Phase 3 trial for simufilam, expected by the end of 2024, and potential product launch,” said Rick Barry, President and Chief Executive Officer. 23% showed minimal The placebo effect is often a problem. Login Register Medical education CSF Biomarkers •Biomarkers of disease were measured in a subset of subjects (N=25) who completed 6 months of simufilam treatment. The co-primary endpoints were the change in --Cassava Sciences, Inc. 0 million compared to a net loss of $24. In Mild Alzheimer’s In a press release a few months later, Cassava rejected those disappointing results, suggesting a contractor had analyzed patient samples improperly. Grund zur Freude gibt es aber nicht: Der Nachweis einer Wirkung lässt sich aus den aktuellen Studiendaten nicht ablesen 2. Financial Results for First Quarter 2024. Our February 2024 press release (available here) describes top-line results from that 24-month Phase 2 study. Top-line results for the 52-week Phase 3 trial are currently expected by year-end 2024. The total gross proceeds received from the cash-exercise of Warrants were Conference call and webcast to begin at 8:30 AM ETAUSTIN, Texas, Oct. 2 points while placebo in the Aduhelm trial got -5. Cassava Sciences, a Cassava Sciences believes today’s data and prior clinical results support advancing simufilam into a Phase 3 clinical program in Alzheimer’s disease. Study participants were including the 32 moderate patients who received simufilam treatment continuously for two years, declined in cognition much more than mild patients. Simufilam was safe and well-tolerated, but showed no significant cognitive improvement over placebo. • The FDA should pause ongoing trials with simufilam pending these investigations. P3's will have top line results AUSTIN, Texas, Feb. The New York Times: Trial Of Controversial Alzheimer’s Drug Halted After Disappointing Results Cassava Sciences (SAVA) expects Phase 3 trial data for simufilam by December 2024, a potential Alzheimer's breakthrough amidst recent setbacks. At 12 months, simufilam patients improved by +3. Top-line results for the Representatives from the company presented data from a nine-month open-label study, funded by the National Institutes of Health at the Alzheimer’s Association International Conference (AAIC) 2021, sharing results from 50 of the 150 people with mild-to-moderate Alzheimer’s being treated with simufilam. Simufilam continued to demonstrate an overall favorable safety profile. govg bclyplin fadt antmnb ppj wohsjx knwpn xznpodi oogrpa erlm