Recognify Life Sciences' Phase 2b Trial of Inidascamine in CIAS Fails to Meet Primary Endpoint, but Shows Modest Improvements and Favorable Safety Profile

Recognify Life Sciences announced that its Phase 2b trial of inidascamine for treating cognitive impairment associated with schizophrenia did not meet its primary endpoint. The trial showed modest numerical improvements despite no statistical significance. Inidascamine maintained a favorable safety profile with no common side effects like sedation or weight gain. Recognify plans to continue analyzing secondary endpoints and subgroup data to guide future development strategies.

Recognify Life Sciences, a subsidiary of atai Life Sciences (NASDAQ: ATAI), announced that its Phase 2b clinical trial of inidascamine for treating cognitive impairment associated with schizophrenia (CIAS) did not meet its primary endpoint of statistical significance. The trial, involving 242 patients across the United States and Europe, demonstrated modest numerical improvements in cognitive and functional measures despite failing to achieve the required statistical significance.

Inidascamine, an orally available compound, showed consistent improvements across multiple cognitive domains, including Symbol Coding, Speed of Processing, and Verbal Learning (immediate recall). Additionally, the drug exhibited directional positive effects on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT), a measure of real-world functional cognitive capacity. The trial also reported a favorable safety profile with no evidence of sedation, weight gain, or extrapyramidal symptoms, which are common side effects associated with traditional treatments for schizophrenia.

Recognify Life Sciences plans to continue analyzing secondary endpoints and subgroup data to identify potential responder populations and guide future development strategies. The company is committed to addressing the significant unmet clinical needs in cognitive impairment associated with mental health and neurodegenerative conditions.

The Phase 2b trial was conducted as a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of two doses of inidascamine versus placebo over a six-week treatment period. The full data set, including secondary endpoints and subgroup analyses, is ongoing and will be presented at upcoming scientific meetings.

Recognify Life Sciences is a clinical-stage biotech company focused on developing treatments for cognitive impairment. Inidascamine has previously been evaluated in ten clinical studies, including one in the CIAS indication, with over 600 unique participants dosed to date. The company is a strategic investment of atai Life Sciences, which is also advancing a pipeline of psychedelic-based therapies for various mental health disorders.

References:
[1] https://www.biospace.com/press-releases/recognify-life-sciences-provides-update-on-phase-2b-trial-of-inidascamine-in-patients-with-cognitive-impairment-associated-with-schizophrenia
[2] https://www.stocktitan.net/news/ATAI/recognify-life-sciences-provides-update-on-phase-2b-trial-of-yc4zk62tc15h.html