Cognition Therapeutics secures polymorph patent for zervimesine to 2045

Cognition Therapeutics has announced the grant of a US composition of matter patent covering a novel polymorphic crystalline form of zervimesine (CT1812), its lead candidate for neurodegenerative diseases. The patent, assigned US Patent No. 12,759,979 by the United States Patent and Trademark Office, carries a natural expiry of 2045 and could be extended by up to five additional years upon FDA approval of the drug.

The granted patent covers three layers of protection: the crystalline polymorph itself, a proprietary process for manufacturing it, and therapeutic methods for treating Alzheimer's disease, dementia with Lewy bodies (DLB) and dry age-related macular degeneration. Cognition said the new form has improved pharmaceutical and physiochemical properties that make it better suited to the large-scale production required for a Phase 3 programme and eventual commercialisation.

Manufacturing shift and regulatory timeline

Anthony Caggiano, chief medical officer at Cognition, said the company has an FDA meeting scheduled for next week to finalise endpoint selection for a registrational programme in DLB. "The form of zervimesine covered by this patent has an enhanced pharmaceutical and physiochemical profile, which is more suitable for the large-scale manufacturing required for Phase 3 and commercialisation," Caggiano said, adding that manufacturing of the new form is planned to begin in the first quarter of 2027 if the FDA meeting concludes favourably.

Zervimesine is an investigational once-daily oral small molecule that targets toxic oligomers, which the company believes drive disease progression across multiple neurodegenerative indications. Cognition completed Phase 2 studies in DLB, mild-to-moderate Alzheimer's disease, and geographic atrophy secondary to dry AMD. The company said efficacy signals from the Phase 2 SHIMMER study in DLB, which examined psychosis in Lewy body patients, underpinned the decision to pursue a registrational trial in that indication. An ongoing Phase 2 study, START, is evaluating zervimesine in mild cognitive impairment and early Alzheimer's disease.

Market and competitive context

The DLB therapeutic space remains substantially underserved. No disease-modifying agent is currently approved specifically for DLB-associated psychosis in the US, and the condition is frequently misdiagnosed, complicating clinical trial recruitment and regulatory pathway design. The indication is adjacent to, but distinct from, Alzheimer's disease, and regulators have historically required DLB-specific endpoint packages rather than repurposing Alzheimer's disease trial designs.

Broader competition in the neurodegenerative space has intensified following recent FDA approvals and rejections in Alzheimer's disease, raising the bar for what constitutes acceptable evidence in late-stage neurodegenerative trials. Cognition's oral, once-daily profile would differentiate zervimesine from approved anti-amyloid antibody infusion therapies if the company can demonstrate efficacy in a registrational setting. The company has disclosed that it has received nearly $200 million in grants from the National Institutes of Health and affiliated foundations, which has reduced its reliance on equity financing and extended its development runway.

The polymorph patent grant is a meaningful but incremental step. Composition of matter protection on a specific crystalline form is generally considered a secondary patent rather than a primary compound patent, and its commercial value depends heavily on whether the approved drug product uses this form exclusively. Investors and partners will focus on the outcome of next week's FDA meeting and the clarity it provides on the DLB registrational endpoint package as the more consequential near-term catalyst.