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PURCHASE, N.Y. - Cognition Therapeutics, Inc. (NASDAQ: CGTX), a biopharmaceutical firm with a market capitalization of $24.5 million focused on neurodegenerative diseases, has reported preliminary positive results from a Phase 2 trial of zervimesine in treating geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD (NASDAQ:AMD)). The masked data analysis revealed that patients receiving zervimesine for at least six months exhibited slower lesion growth compared to those on a placebo. While the stock has declined 74% over the past year, InvestingPro analysis suggests the company is currently undervalued.
The MAGNIFY study, which has enrolled 100 participants, is set to conclude with a final clinic visit this February. The company plans to unblind the study at the end of the month and expects to provide a full analysis, including 12-month dosing data, in the second quarter of 2025. According to InvestingPro data, two analysts have recently revised their earnings estimates upward for the upcoming period, suggesting growing confidence in the company’s prospects.
Zervimesine, also known as CT1812, is an investigational oral medication being developed to treat central nervous system diseases such as Alzheimer’s disease and dementia with Lewy bodies (DLB). The drug is believed to interact with the sigma-2 receptor, potentially regulating pathways impaired in these diseases.
The early termination of the MAGNIFY study was a strategic decision to preserve capital, allowing Cognition to reallocate financial resources to other indications. This follows the successful completion of the Phase 2 SHIMMER study in DLB and the SHINE study in Alzheimer’s disease, both meeting primary endpoints of safety and tolerability.
In the SHIMMER study, zervimesine-treated participants showed significant improvement across several measures compared to those on placebo, including an 86% better performance on the neuropsychiatric inventory and a 62% improvement on a motor function measure. A subgroup in the SHINE study demonstrated a 95% reduction in cognitive decline.
Cognition Therapeutics plans to meet with the U.S. Food and Drug Administration to discuss the results and the design of registrational studies for Alzheimer’s disease and DLB.
The information provided is based on a press release statement from Cognition Therapeutics, Inc. The company continues to investigate zervimesine, with the hope that it may slow the progression of diseases like Alzheimer’s and DLB and improve patient outcomes.
In other recent news, Cognition Therapeutics has developed a new chemical process for manufacturing zervimesine (CT1812), a drug under investigation for treating neurodegenerative disorders. This process, highlighted in a publication by the American Chemical Society, aims to improve the efficiency and safety of synthesizing the drug. Additionally, the company has identified a new polymorphic form of zervimesine that enhances stability at room temperature, potentially extending its shelf life. In related developments, H.C. Wainwright has raised its price target for Cognition Therapeutics to $6.00 from $5.00, maintaining a Buy rating following positive results from the Phase 2 SHIMMER trial of CT1812. The trial, which focused on patients with dementia with Lewy bodies, met its primary endpoint and showed improvements in various health measures. Cognition Therapeutics recently concluded the SHIMMER study and anticipates reporting topline results in December 2024. The study was supported by a $30 million grant from the National Institute on Aging and was conducted in collaboration with several institutions. The company continues to explore its pipeline of sigma-2 receptor modulators in other clinical trials.
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