Cognition Therapeutics completes enrollment in Alzheimer’s drug trial

PURCHASE, N.Y. - Cognition Therapeutics, Inc. (NASDAQ:CGTX) announced Thursday it has reached its target enrollment of 540 participants in the Phase 2 START Study testing its oral drug zervimesine in patients with mild cognitive impairment or early Alzheimer’s disease. The clinical-stage biotech, currently valued at $151.83 million, has seen its stock surge 220% over the past year as development of its Alzheimer’s candidate progresses, though InvestingPro analysis indicates the company may be trading above its Fair Value.

The company reported that approximately 15% of participants in the study are also receiving approved monoclonal antibody therapies Leqembi (lecanemab) or Kisunla (donanemab), allowing for potential evaluation of combination treatment approaches.

According to the company, enrollment accelerated significantly in recent months, with about half of the study population enrolled during the last six months. Cognition Therapeutics attributed this to increased investigator interest following presentations of its Phase 2 results in mild-to-moderate Alzheimer’s disease and dementia with Lewy bodies at international conferences.

"Our clinical operations teams drove impressive enrollment numbers this year based on strong interest from patients and investigators," said Lisa Ricciardi, Cognition’s president and CEO.

The START Study is designed to measure the efficacy and tolerability of once-daily oral zervimesine over 18 months using validated cognitive assessment tools. The trial is supported by an $81 million grant from the National Institute of Aging and conducted in collaboration with the Alzheimer’s Clinical Trials Consortium.

Zervimesine, which targets the sigma-2 receptor, represents a different mechanism of action from currently approved antibody therapies. The company states the drug has been generally well tolerated in clinical studies to date.

Topline results from the START Study are expected after all participants complete 18 months of treatment.

The information in this article is based on a company press release statement.

In other recent news, Cognition Therapeutics announced the completion of its $30 million registered direct offering, raising significant funds through the sale of 14,700,000 shares of common stock. This transaction was facilitated by Titan Partners Group, a division of American Capital Partners. Meanwhile, the company reached a 75% enrollment milestone in its Phase 2 START Study for the Alzheimer’s drug zervimesine (CT1812), highlighting ongoing progress in its clinical trials. The study is supported by the Alzheimer’s Clinical Trials Consortium and funded by the National Institute of Aging. Additionally, Cognition Therapeutics regained Nasdaq compliance by meeting the minimum share price requirement, a positive development for its market standing. The company also received a boost after the FDA confirmed that its Phase 3 program design for the Alzheimer’s drug candidate could support a New Drug Application. This endorsement allows Cognition to proceed with enrolling patients for the next phase of trials. These recent developments reflect Cognition Therapeutics’ active engagement in advancing its research and financial strategies.

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