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PURCHASE, N.Y. - Cognition Therapeutics, Inc. (NASDAQ:CGTX) announced Wednesday that it has completed enrollment for its expanded access program for zervimesine, an investigational drug being developed for dementia with Lewy bodies (DLB). The clinical-stage biotech company, currently valued at $142 million, has seen its stock price surge over 316% in the past year as investors show growing interest in its neurodegenerative disease pipeline.
The program, which enrolled participants in just three months, provides daily 100 mg oral doses of zervimesine for up to one year to eligible patients who completed the company’s Phase 2 SHIMMER study, as well as additional patients with mild-to-moderate DLB who meet enrollment criteria.
"We are grateful to the family who made it possible to provide expanded access to zervimesine for people who were in the Phase 2 DLB study," said Lisa Ricciardi, president and CEO of Cognition Therapeutics, in a press release statement.
Dr. Lawrence S. Honig, professor of neurology at Columbia University Irving Medical Center and an investigator in the program, noted that the rapid enrollment reflects high interest among DLB patients.
The company also announced that the FDA has scheduled a Type C meeting for the second half of January to discuss the proposed design of a Phase 3 program for zervimesine in DLB patients.
Zervimesine is an oral, once-daily investigational drug being developed for central nervous system diseases including Alzheimer’s disease and DLB. According to the company, the drug has been generally well tolerated in clinical studies to date.
The expanded access program is being conducted under study identifier NCT06961760 on clinicaltrials.gov, with Dr. James E. Galvin of the University of Miami Miller School of Medicine serving as lead investigator.
As an investigational medicine, zervimesine has not yet received regulatory approval, and its safety and efficacy have not been fully characterized.
In other recent news, Cognition Therapeutics, Inc. has shared updates on its Alzheimer’s drug trials. The company outlined plans for its Phase 3 program at the Clinical Trials on Alzheimer’s Disease conference, focusing on the drug zervimesine for mild-to-moderate Alzheimer’s disease. This program follows the Phase 2 "SHINE" study results, which indicated a significant slowing of cognitive decline in participants with lower plasma p-tau217 levels. Cognition Therapeutics also announced the completion of enrollment for its Phase 2 START Study, reaching its target of 540 participants. Notably, 15% of these participants are receiving additional monoclonal antibody therapies, Leqembi or Kisunla, which may allow for the evaluation of combination treatments. The company had previously reported achieving a 75% enrollment milestone in the same study, highlighting the strong interest in this oral medication option. The study is being conducted in collaboration with the Alzheimer’s Clinical Trials Consortium and is funded by the National Institute of Aging at the National Institutes of Health. These developments reflect Cognition Therapeutics’ ongoing efforts in advancing treatment options for Alzheimer’s disease.
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