To evaluate the absorption, metabolism, and excretion of [14C]-simufilam in healthy male subjects following a single oral administration of 100 mg of (approximately 100 µCi) [14C]-simufilam.

Start Date07 Feb 2024

Sponsor / Collaborator

Cassava Sciences, Inc.

NCT05575076

/ Active, not recruitingPhase 3

An Open-label, Long-term Extension Study to Evaluate the Safety and Tolerability of Simufilam 100 mg Tablets in Participants With Mild to Moderate Alzheimer's Disease

The goal of this open-label extension study is to assess long-term safety and tolerability of simufilam 100 mg in subjects who have completed the RETHINK-ALZ or REFOCUS-ALZ Phase 3 clinical trials.

Start Date07 Nov 2022

Sponsor / Collaborator

Cassava Sciences, Inc.

100 Clinical Results associated with Sumifilam

100 Translational Medicine associated with Sumifilam

100 Patents (Medical) associated with Sumifilam

Literatures (Medical) associated with Sumifilam

04 Oct 2024·Science

Firm misled investors on Alzheimer’s drug, SEC charges

Author: Piller, Charles

Agency fines Cassava Sciences $40 million for touting flawed research on simufilam

01 Feb 2024·Ageing Research Reviews

Navigating the dementia landscape: Biomarkers and emerging therapies

Review

Author: Wasim, Rufaida ; Verma, Amita ; Akhtar, Juber ; Maheshwari, Shubhrat ; Ansari, Vaseem Ahamad ; Mahmood, Tarique ; Singh, Aditya

The field of dementia research has witnessed significant developments in our understanding of neurodegenerative disorders, with a particular focus on Alzheimer's disease (AD) and Frontotemporal Dementia (FTD). Dementia, a collection of symptoms arising from the degeneration of brain cells, presents a significant healthcare challenge, especially as its prevalence escalates with age. This abstract delves into the complexities of these disorders, the role of biomarkers in their diagnosis and monitoring, as well as emerging neurophysiological insights. In the context of AD, anti-amyloid therapy has gained prominence, aiming to reduce the accumulation of amyloid-beta (Aβ) plaques in the brain, a hallmark of the disease. Notably, Leqembi recently received full FDA approval, marking a significant breakthrough in AD treatment. Additionally, ongoing phase 3 clinical trials are investigating novel therapies, including Masitinib and NE3107, focusing on cognitive and functional improvements in AD patients. In the realm of FTD, research has unveiled distinct neuropathological features, including the involvement of proteins like TDP-43 and progranulin, providing valuable insights into the diagnosis and management of this heterogeneous condition. Biomarkers, including neurofilaments and various tau fragments, have shown promise in enhancing diagnostic accuracy. Neurophysiological techniques, such as transcranial magnetic stimulation (TMS), have contributed to our understanding of AD and FTD. TMS has uncovered unique neurophysiological signatures, highlighting impaired plasticity, hyperexcitability, and altered connectivity in AD, while FTD displays differences in neurotransmitter systems, particularly GABAergic and glutamatergic circuits. Lastly, ongoing clinical trials in anti-amyloid therapy for AD, such as Simufilam, Solanezumab, Gantenerumab, and Remternetug, offer hope for individuals affected by this devastating disease, with the potential to alter the course of cognitive decline. These advancements collectively illuminate the evolving landscape of dementia research and the pursuit of effective treatments for these challenging conditions.

11 Sep 2023·International journal of molecular sciences

Simufilam Reverses Aberrant Receptor Interactions of Filamin A in Alzheimer's Disease.

Article

Author: Pei, Zhe ; Jockers, Ralf ; Dam, Julie ; Wang, Hoau-Yan ; Cecon, Erika ; Burns, Lindsay H

Simufilam is a novel oral drug candidate in Phase 3 clinical trials for Alzheimer's disease (AD) dementia. This small molecule binds an altered form of filamin A (FLNA) that occurs in AD. This drug action disrupts FLNA's aberrant linkage to the α7 nicotinic acetylcholine receptor (α7nAChR), thereby blocking soluble amyloid beta_1-42 (Aβ₄₂)'s signaling via α7nAChR that hyperphosphorylates tau. Here, we aimed to clarify simufilam's mechanism. We now show that simufilam reduced Aβ₄₂ binding to α7nAChR with a 10-picomolar IC₅₀ using time-resolved fluorescence resonance energy transfer (TR-FRET), a robust technology to detect highly sensitive molecular interactions. We also show that FLNA links to multiple inflammatory receptors in addition to Toll-like receptor 4 (TLR4) in postmortem human AD brains and in AD transgenic mice: TLR2, C-X-C chemokine receptor type 4 (CXCR4), C-C chemokine receptor type 5 (CCR5), and T-cell co-receptor cluster of differentiation 4 (CD4). These aberrant FLNA linkages, which can be induced in a healthy control brain by Aβ₄₂ incubation, were disrupted by simufilam. Simufilam reduced inflammatory cytokine release from Aβ₄₂-stimulated human astrocytes. In the AD transgenic mice, CCR5-G protein coupling was elevated, indicating persistent activation. Oral simufilam reduced both the FLNA-CCR5 linkage and the CCR5-G protein coupling in these mice, while restoring CCR5's responsivity to C-C chemokine ligand 3 (CCL3). By disrupting aberrant FLNA-receptor interactions critical to AD pathogenic pathways, simufilam may promote brain health.

103

News (Medical) associated with Sumifilam

14 Jan 2025

·www.prnewswire.com

Class Action Filed Against Cassava Sciences, Inc. (SAVA) Seeking Recovery for Investors - Contact Levi & Korsinsky

NEW YORK, Jan. 14, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Cassava Sciences, Inc. ("Cassava Sciences, Inc." or the "Company") (NASDAQ: SAVA) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Cassava Sciences, Inc. investors who were adversely affected by alleged securities fraud between February 7, 2024 and November 24, 2024. Follow the link below to get more information and be contacted by a member of our team: SAVA investors may also contact Joseph E. Levi, Esq. via email at [email protected] or by telephone at (212) 363-7500. CASE DETAILS: According to the complaint, defendants provided investors with material information concerning Cassava's leading drug candidate, simufilam. Defendants' statements included, among other things, clear confidence in simufilam's ability to treat Alzheimer's Disease. On November 25, 2024, Cassava released topline results for the first of its two ongoing Phase 3 studies on simufilam, the "ReThink-ALZ" study. 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. Following this news, the price of Cassava's common stock declined dramatically. From a closing market price of $26.48 per share on November 22, 2024, Cassava's stock price fell to $4.30 per share on November 25, 2024, a decline of about 83.76% in the span of just a single day. WHAT'S NEXT? If you suffered a loss in Cassava Sciences, Inc. during the relevant time frame, you have until February 10, 2025 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. NO COST TO YOU: If you are a class member, you may be entitled to compensation without payment of any out-of-pocket costs or fees. There is no cost or obligation to participate. WHY LEVI & KORSINSKY: Over the past 20 years, the team at Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. Our firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States. CONTACT: Levi & Korsinsky, LLP Joseph E. Levi, Esq. Ed Korsinsky, Esq. 33 Whitehall Street, 17th Floor New York, NY 10004 [email protected] Tel: (212) 363-7500 Fax: (212) 363-7171 SOURCE Levi & Korsinsky, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Financial Statement

31 Dec 2024

·www.prnewswire.com

Shareholders that lost money on Cassava Sciences, Inc.(SAVA) should contact Levi & Korsinsky about pending Class Action - SAVA

NEW YORK, Dec. 31, 2024 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Cassava Sciences, Inc. ("Cassava Sciences, Inc." or the "Company") (NASDAQ: SAVA) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Cassava Sciences, Inc. investors who were adversely affected by alleged securities fraud between February 7, 2024 and November 24, 2024. Follow the link below to get more information and be contacted by a member of our team: SAVA investors may also contact Joseph E. Levi, Esq. via email at [email protected] or by telephone at (212) 363-7500. CASE DETAILS: According to the complaint, defendants provided investors with material information concerning Cassava's leading drug candidate, simufilam. Defendants' statements included, among other things, clear confidence in simufilam's ability to treat Alzheimer's Disease. On November 25, 2024, Cassava released topline results for the first of its two ongoing Phase 3 studies on simufilam, the "ReThink-ALZ" study. 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. Following this news, the price of Cassava's common stock declined dramatically. From a closing market price of $26.48 per share on November 22, 2024, Cassava's stock price fell to $4.30 per share on November 25, 2024, a decline of about 83.76% in the span of just a single day. WHAT'S NEXT? If you suffered a loss in Cassava Sciences, Inc. during the relevant time frame, you have until February 10, 2025 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. NO COST TO YOU: If you are a class member, you may be entitled to compensation without payment of any out-of-pocket costs or fees. There is no cost or obligation to participate. WHY LEVI & KORSINSKY: Over the past 20 years, the team at Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. Our firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States. CONTACT: Levi & Korsinsky, LLP Joseph E. Levi, Esq. Ed Korsinsky, Esq. 33 Whitehall Street, 17th Floor New York, NY 10004 [email protected] Tel: (212) 363-7500 Fax: (212) 363-7171 SOURCE Levi & Korsinsky, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Financial Statement

17 Dec 2024

·www.prnewswire.com

Levi & Korsinsky Notifies Cassava Sciences, Inc. Investors of a Class Action Lawsuit and Upcoming Deadline - SAVA

NEW YORK, Dec. 17, 2024 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Cassava Sciences, Inc. ("Cassava Sciences, Inc." or the "Company") (NASDAQ: SAVA) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Cassava Sciences, Inc. investors who were adversely affected by alleged securities fraud between February 7, 2024 and November 24, 2024. Follow the link below to get more information and be contacted by a member of our team: SAVA investors may also contact Joseph E. Levi, Esq. via email at [email protected] or by telephone at (212) 363-7500. CASE DETAILS: According to the complaint, defendants provided investors with material information concerning Cassava's leading drug candidate, simufilam. Defendants' statements included, among other things, clear confidence in simufilam's ability to treat Alzheimer's Disease. On November 25, 2024, Cassava released topline results for the first of its two ongoing Phase 3 studies on simufilam, the "ReThink-ALZ" study. 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. Following this news, the price of Cassava's common stock declined dramatically. From a closing market price of $26.48 per share on November 22, 2024, Cassava's stock price fell to $4.30 per share on November 25, 2024, a decline of about 83.76% in the span of just a single day. WHAT'S NEXT? If you suffered a loss in Cassava Sciences, Inc. during the relevant time frame, you have until February 10, 2025 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. NO COST TO YOU: If you are a class member, you may be entitled to compensation without payment of any out-of-pocket costs or fees. There is no cost or obligation to participate. WHY LEVI & KORSINSKY: Over the past 20 years, the team at Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. Our firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States. CONTACT: Levi & Korsinsky, LLP Joseph E. Levi, Esq. Ed Korsinsky, Esq. 33 Whitehall Street, 17th Floor New York, NY 10004 [email protected] Tel: (212) 363-7500 Fax: (212) 363-7171 SOURCE Levi & Korsinsky, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Financial Statement

100 Deals associated with Sumifilam

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 3	AU	Cassava Sciences, Inc.	03 Nov 2021
Alzheimer Disease	Phase 3	CA	Cassava Sciences, Inc.	03 Nov 2021
Alzheimer Disease	Phase 3	US	Cassava Sciences, Inc.	03 Nov 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04994483 (ReThink-ALZ, Company_Website) Manual	Phase 3	Alzheimer Disease	804	Simufilam	(qvpgqffmmq) = kwiofurwci kclekvkqvc (jbhjojljsk, 0.36) View more	Negative	25 Nov 2024
				Placebo	(qvpgqffmmq) = dhbvwlkzhe kclekvkqvc (jbhjojljsk, 0.36) View more
NCT04388254 (GlobeNewswire) Manual	Phase 2	Alzheimer Disease	-	Simufilam 100 mg (mild Alzheimer’s disease; treatment continuously for two years)	(jjyutxrqcx) = yltkvglmzr mkoeoqijhg (leruughzbr, 1.51) View more	Positive	07 Feb 2024
				Simufilam 100 mg (mild Alzheimer’s disease; treatment continuously for two years)	(jjyutxrqcx) = ysjbdqwkel mkoeoqijhg (leruughzbr, 1.65) View more
NCT05026177 \| NCT04994483 (REFOCUS-ALZ \| RETHINK-ALZ, Corporate Publications) Manual	Phase 3	Alzheimer Disease	100	simufilam	(xizsozsubw) = ojmsvobnvi usubxkqtlf (esijfqxqny ) View more	-	03 Aug 2022
AAIC2021	Not Applicable	Alzheimer Disease	150	Simufilam 100 mg	(pxivguyojh) = irwdfdjskh feptlwtuuj (wnqwzotsuz ) View more	Positive	31 Dec 2021
NCT04388254 (Corporate Publications) Manual	Phase 2	Alzheimer Disease	50	simufilam	(cwkttzufnu) = tyarqessaz edraihihjx (obqjbobhvn ) View more	Positive	22 Sep 2021
				Placebo	(cwkttzufnu) = yjcqmuefrr edraihihjx (obqjbobhvn )
NCT04079803 (CTgov)	Phase 2	Alzheimer Disease	64	Placebo oral tablet (Placebo Cohort)	pwyvfvlwdx(herfaqjipn) = dmbltlxykm svtujzcxop (dmfzojmrdz, lenfdtmjbo - pdmpqxaiik) View more	-	01 Jun 2021
				Simufilam 50 mg oral tablet (Simufilam (PTI-125) 100 mg Tablets Cohort)	shttuwezfo(mtljezaffy) = pfquuiwrak kmpshiearc (oqwevdohge, vbsrtoeazo - arzrfcwxve) View more
NCT03784300 (CTgov)	Phase 1	Alzheimer Disease	24	50 mg PTI-125 (50 mg PTI-125)	(xnzcsnaofi) = gbyizvhiyi bxgamqlhgy (kuzkcchklv, gncahpnbdu - vkmprvclvf) View more	-	10 May 2021
				50 mg PTI-125 (50 mg PTI-125 Placebo)	(xnzcsnaofi) = xwwjmvbgbh bxgamqlhgy (kuzkcchklv, jnwxvgcwfn - qcpyhnqoir) View more
NCT03748706 (CTgov)	Phase 2	Alzheimer Disease	13	PTI-125	irrozaezvh(bbtjpzzoau) = zereeijluh qwwbcojlrr (khjlmiraft, tsmkumbkmz - cefsroxlbl) View more	-	01 Apr 2021
NCT04079803 (GlobeNewswire) Manual	Phase 2	Alzheimer Disease	64	PTI-125	(hgontarswr) = did not meet its primary endpoint ftnppxxpfz (sutbuqyvfi ) View more	Negative	15 May 2020
				Placebo

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