Cognition Therapeutics, has received a patent from the United States Patent and Trademark Office (USPTO) covering a novel crystalline form of zervimesine, its lead investigational drug candidate for neurodegenerative disorders. The patent has a natural expiration date in 2045 and may be eligible for an extension of up to five additional years following approval of zervimesine by the US Food and Drug Administration (FDA).

The patent, numbered US 12,759,979 and titled “Crystalline forms of 2-(tert-butoxy)-4-(3-methyl-3-(5-(methylsulfonyl) isoindolin-2-yl)butyl)phenol fumarate salt,” covers the crystalline form of zervimesine, a proprietary process for its production, and methods of treating Alzheimer’s disease, dry Age-related Macular Degeneration (dry AMD) and Dementia with Lewy Bodies (DLB).

According to Anthony Caggiano, MD, PhD, Chief Medical Officer of Cognition Therapeutics, the patented form has an improved pharmaceutical and physicochemical profile suited to large-scale manufacturing for Phase III development and potential commercialisation.

The company has a meeting scheduled with the FDA to discuss and finalise endpoint selection for its planned registrational programme in DLB. Subject to a favourable outcome, Cognition Therapeutics plans to begin manufacturing the new crystalline form in the first quarter of 2027 for use in the registrational clinical trial.

Zervimesine is an investigational, once-daily oral therapy that has been evaluated in Phase 2 studies involving patients with DLB, mild-to-moderate Alzheimer’s disease and geographic atrophy secondary to dry AMD. The candidate is also being studied in the Phase II START trial in patients with mild cognitive impairment and early Alzheimer’s disease.

Based partly on efficacy signals observed in the Phase 2 SHIMMER study (NCT05225415), Cognition Therapeutics plans to advance zervimesine into a registrational trial involving patients with DLB who experience psychosis. The company has reported that the candidate has generally been well tolerated in clinical studies to date.

The USAN Council has adopted zervimesine as the United States Adopted Name for CT1812. Cognition Therapeutics is a clinical-stage biopharmaceutical company developing investigational therapies for neurodegenerative diseases.