Shares of clinical-stage drug platform company
Annovis Bio, Inc. ( ANVS Quick Quote ANVS - Free Report) gained 9.22% after the company announced a positive interim independent analysis from its Alzheimer’s Disease (AD) study on buntanetap.
Buntanetap is an experimental, oral translational inhibitor of neurotoxic aggregating proteins. This mode of action is expected to lead to a lower level of neurotoxic proteins and consequently less toxicity in the brain.
This phase II/III AD study has been designed to enroll a total of 320 mild to moderate AD patients. These patients are randomly assigned to receive either 7.5, 15, 30 mg of buntanetap or placebo once per day.
The co-primary endpoints of the study are the change from baseline to the end of treatment of Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) and Alzheimer’s Disease Cooperative Study Clinician’s Global Impression of Change (ADCS-CGIC), which assess cognition and activities of daily living.
The interim analysis was based on 107 patients at six weeks from all cohorts collectively. Results conducted by an independent data analytics provider indicated that the AD trial should continue as planned with the same trial size to maintain the statistical power for both co-primary endpoints. Recruitment of additional patients is not required.
Per the management, since sample size re-estimation for the study is unnecessary, it signals that treatment effects in patients receiving buntanetap are positive vis-à-vis those receiving placebo after just 6 weeks of treatment.
Annovis remains blinded to the phase III study and does not have safety or efficacy data from the trial.
About 230 patients have been enrolled to date and 62 have finished the study. Total enrollment will be completed in November.
Meanwhile, a separate safety interim analysis is in process and results are expected to be released in two weeks.
Buntanetap is also being evaluated for Parkinson's disease (PD). Annovis conducted two phase II studies: one in AD patients and one in both AD and PD patients. In the AD/PD study buntanetap showed improvements in cognition and memory in AD and body and brain function in PD patients. A phase III early PD study is ongoing.
Annovis expects to discuss with the FDA the transition buntanetap to a novel crystal form of buntanetap - ANVS402. The bridge studies are expected to be completed in the first quarter of 2024.
Year to date, shares of Annovis have declined 37.4% compared with the
industry’s 18.9% fall. Image Source: Zacks Investment Research
The successful development of buntanetap in AD will be a significant boost for the company.
The recent spotlight on the AD space has put the spotlight on companies developing treatments for the same.
In July, the FDA approved
Biogen's ( BIIB Quick Quote BIIB - Free Report) and partner Eisai’s supplemental biologics license application, supporting the traditional approval of their AD drug Leqembi (lecanemab). The drug was initially granted accelerated approval for a similar indication in January. The traditional approval is based on data from Eisai’s late-stage global Clarity AD clinical study, wherein Leqembi met its primary endpoint and all key secondary endpoints with statistically significant results and confirmed the clinical benefit of Leqembi.
The approval raised investors’ hopes for other companies with AD candidates in their pipeline.
Prothena ( PRTA Quick Quote PRTA - Free Report) , another clinical-stage company, also has an impressive pipeline with AD candidates that spans next-generation antibody immunotherapy, small molecules and vaccines.
In July 2023, Prothena shared encouraging progress on three investigational product programs for treating and preventing AD, PRX005, PRX012 and PRX123.
Annovis currently has a Zacks Rank #2 (Buy). You can see
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