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Cassava (SAVA) Responds to Charges Against its Integrity in AD Study

Cassava (SAVA) plunges following charges against its scientific integrity in developing a drug for Alzheimer's disease. The company responds to the sa...

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This story originally appeared on Zacks

Cassava Sciences SAVA has issued a response to the citizen petition questioning its scientific integrity in developing a drug for Alzheimer’s disease (AD).

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Cassava is developing simufilam for the treatment of AD.  Simufilam is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA), a scaffolding protein, in the brain.

Its shares were down 31.4% on Aug 25 following news of the petition requesting the FDA to halt the current clinical studies of Simufilam PTI-125 sponsored by Cassava questioning integrity of the studies on various grounds.

Per the petition, biomarker data is generated by Cassava or its science collaborators and therefore are falsified. Among others, it was also alleged that extensive use of Western blot analysis is foundational to Cassava’s research, and western blots data appear overexposed and highly processed, suggesting image manipulation.

Cassava’s stock has surged 1085.6% in the year so far against the industry’s decrease of 11.7%.

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Cassava came out with a response addressing the various allegations. Per the company, plasma p-tau data from Alzheimer’s patients was generated by Quanterix Corp., an independent company.

Per the company, it has reached an agreement with the FDA on Special Protocol Assessments (SPA) for its phase III studies of simufilam for the treatment of AD. The SPAs underscore alignment with the FDA on key scientific, clinical and regulatory requirements of the phase III program of simufilam in AD.

Cassava also reaffirmed prior guidance to advance simufilam into a phase III program in AD in fall 2021.

We note that the FDA approval of Biogen’s BIIB AD drug, Aduhelm, has put the spotlight on this promising yet challenging space. In June 2021, Biogen and partner Eisai won the FDA approval for Aduhelm (aducanumab-avwa) as the first and only AD treatment, after a few setbacks.

The approval has brought the spotlight on other companies that are developing drugs for the disease. Investors are optimistic about the prospects of these pipeline candidates.

Among the companies developing drugs for the same is Prothena PRTA. Its pipeline candidate PRX005 is being evaluated for the treatment of AD. The candidate is being developed as part of the global neuroscience research and development collaboration with Bristol Myers Squibb.

Eli Lilly and Company LLY is also developing donanemab, an investigational antibody therapy for AD. In June, the FDA granted Breakthrough Therapy designation to donanemab for AD.

Cassava currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.



 

 

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