Cognition Therapeutics Inc (NASDAQ:CGTX) saw its stock jump 27% following FDA confirmation that the company’s proposed Phase 3 program for its Alzheimer’s drug candidate could form the basis for a New Drug Application (NDA).
The clinical-stage neurodegenerative disease developer received the final minutes from its end-of-Phase 2 meeting with the FDA, held on July 9. The agency endorsed Cognition’s plan to enroll adults with mild-to-moderate Alzheimer’s disease who exhibit lower p-tau217 levels at screening for its Phase 3 trials of zervimesine (CT1812).
Cognition said that prior clinical data indicate zervimesine can halt cognitive decline by 95% versus placebo in this patient population, supporting the use of plasma p-tau217 as a predictive biomarker to select patients most likely to benefit from the treatment.
“In the meeting minutes, FDA concurred with our plan to enrich the Phase 3 study population with Alzheimer’s patients who have lower p-tau217,” said Anthony Caggiano, MD, PhD, Cognition’s CMO and head of R&D. “Because p-tau217 can be measured by a simple blood test, we expect this strategy will ease the burden on patients. This enrichment strategy may increase the power of the study and reduce trial costs.”
The Phase 3 program will randomize participants to receive either 100mg of oral zervimesine or placebo daily for six months. Notably, the FDA indicated that two six-month Phase 3 studies could support an NDA filing, potentially accelerating the regulatory pathway for zervimesine.
Cognition Therapeutics stock price
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