Cognition Therapeutics (NASDAQ: CGTX) has achieved a significant manufacturing breakthrough for its lead neurodegenerative disease candidate zervimesine (CT1812), as detailed in a new publication in the American Chemical Society journal Organic Process Research & Development.
The newly developed chemical process incorporates cutting-edge technologies, including high-throughput screening and light-induced continuous flow processing, enabling more efficient and safer synthesis of the drug candidate. Notably, researchers have identified a novel crystal form of zervimesine with enhanced room temperature stability, crucial for ensuring extended shelf life.
"The chemical process described in this manuscript leverages innovative technologies to more efficiently and safely synthesize zervimesine," stated Steven A. Weissman, Ph.D., head of CMC at Cognition Therapeutics. "We have also identified a novel crystal form, or polymorph, of zervimesine that has improved stability at room temperature, enabling a long shelf life, as well as other beneficial pharmaceutical properties."
Manufacturing and Patent Strategy
The company has filed provisional patent applications covering both the chemical process and the preferred polymorphic form of zervimesine. This manufacturing advancement positions Cognition Therapeutics to effectively produce materials for ongoing and future clinical studies, while also laying the groundwork for potential commercial production if the drug receives regulatory approval.
Therapeutic Mechanism and Clinical Applications
Zervimesine is being developed as an oral, once-daily treatment for central nervous system (CNS) diseases, specifically targeting Alzheimer's disease and dementia with Lewy bodies (DLB). The drug candidate works through a unique mechanism involving the sigma-2 receptor, distinguishing it from other approaches in the field.
Both target conditions are characterized by the accumulation of toxic proteins in the brain - amyloid beta (Aβ) in Alzheimer's disease and α-synuclein in DLB. These proteins can bind to and ultimately destroy neurons, leading to progressive cognitive decline, impaired movement, and communication difficulties. Zervimesine's potential to interrupt these toxic protein effects could offer hope for slowing disease progression.
Clinical Development Status
The drug is currently being evaluated in multiple clinical programs, including the ongoing START study (NCT05531656) in early Alzheimer's disease. As a clinical-stage biopharmaceutical company, Cognition Therapeutics continues to advance its pipeline of innovative small molecule therapeutics targeting age-related degenerative disorders of the central nervous system.
