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Recognify Life Sciences Provides Update on Phase 2b Trial of Inidascamine in Patients with Cognitive Impairment Associated with Schizophrenia
Globenewswireยท 2025-07-25 20:05
Core Insights - Recognify Life Sciences announced that its Phase 2b clinical trial for inidascamine did not meet its primary endpoint for cognitive improvement in patients with cognitive impairment associated with schizophrenia [1][2] - Despite not achieving statistical significance, inidascamine showed consistent numerical improvements across various cognitive measures, including Symbol Coding and Verbal Learning [2][4] - The drug demonstrated a favorable safety profile, with no significant side effects commonly associated with schizophrenia treatments [3][4] Company Overview - Recognify Life Sciences is a clinical-stage biotech company focused on developing pro-cognitive treatments for mental health and neurodegenerative disorders [10] - The company is a strategic investment of atai Life Sciences, which is also involved in developing psychedelic-based therapies for mental health [11] Clinical Trial Details - The Phase 2b trial enrolled 242 patients across the United States and Europe, evaluating the efficacy, safety, and tolerability of inidascamine over a six-week period [4] - The study's primary endpoint was based on the MCCB neurocognitive composite score, which did not show statistical significance, but secondary and exploratory endpoints are still under analysis [2][4] Future Directions - Recognify Life Sciences plans to present additional results from the study at scientific meetings and will evaluate strategic options for inidascamine based on the complete data set [5][6] - The ongoing analysis aims to identify potential responder populations and mechanistic insights that could guide future development [4][5] Industry Context - Cognitive impairment associated with schizophrenia affects approximately 80% of patients, representing a significant unmet clinical need, as there are currently no effective pharmaceutical treatments approved for this condition [9] - The global prevalence of schizophrenia is over 21 million, with around 2.4 million cases in the United States [9]