Cognition Therapeutics Inc (NASDAQ:CGTX) stock surged 27% after the FDA confirmed that the company’s proposed Phase 3 program design for its Alzheimer’s disease drug candidate could support a New Drug Application (NDA).
The clinical-stage neurodegenerative disease drug developer received final minutes from its end-of-Phase 2 meeting with the FDA, which took place on July 9. The agency endorsed Cognition’s plan to enroll adults with mild-to-moderate Alzheimer’s disease who have lower levels of p-tau217 at screening for its Phase 3 trials of zervimesine (CT1812).
According to the company, previous clinical experience has demonstrated that zervimesine can arrest cognitive deterioration by 95% compared to placebo in this specific patient population. This supports using plasma p-tau217 as a predictive biomarker to identify patients most likely to benefit from 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 either 100mg of oral zervimesine or placebo daily for six months. A key development from the FDA meeting was the agency’s view that two six-month Phase 3 studies could support an NDA filing, potentially accelerating the regulatory timeline for zervimesine.
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