ATAI Life Sciences' Inidascamine Trial Results Fall Short of Expectations, Still Shows Modest Cognitive Benefits

Recognify Life Sciences' Phase 2b trial of inidascamine for schizophrenia-related cognitive impairment did not meet its main goal but showed consistent, modest benefits in cognitive subdomains. The drug was well-tolerated, with side effects like sedation, weight gain, and extrapyramidal symptoms absent. Atai Life Sciences (ATAI) invested in Recognify Life Sciences. Analysts forecast an average target price of $9.83, with a high estimate of $12.00 and a low estimate of $7.00, implying a 175.44% upside from the current price of $3.57.

Recognify Life Sciences, a clinical-stage biotech company, announced that its Phase 2b clinical trial evaluating inidascamine for cognitive impairment associated with schizophrenia (CIAS) did not meet its primary endpoint of statistical significance. The trial, conducted across the United States and Europe, enrolled 242 patients and assessed the efficacy, safety, and tolerability of two doses of inidascamine versus placebo over a six-week treatment period [1].

While the trial did not achieve its primary endpoint, inidascamine demonstrated modest numerical improvements in multiple cognitive domains, including Symbol Coding, Speed of Processing, and Verbal Learning. These improvements were consistent across the overall MCCB neurocognitive composite score and the Virtual Reality Functional Capacity Assessment Tool (VRFCAT), which measures real-world functional cognitive capacity [1].

Inidascamine was well-tolerated, with no evidence of sedation, weight gain, or extrapyramidal symptoms, which are common side effects associated with schizophrenia treatments. The favorable safety profile is consistent with previous studies [1].

Matt Pando, PhD, CEO and Co-Founder of Recognify Life Sciences, commented, "Although we are disappointed that the study did not reach statistical significance on the primary efficacy endpoint, we are encouraged by the consistency of improvement signals across multiple cognitive and functional measures. These findings reinforce our commitment to addressing the significant unmet needs in cognitive impairment associated with mental health and neurodegenerative conditions. Inidascamine continues to exhibit a strong safety profile, and we look forward to analyzing the full data set to better understand the outcome and inform potential next steps for the program" [1].

Recognify plans to present additional results from the study at upcoming scientific meetings and will continue evaluating strategic options for inidascamine based on the totality of data [1].

At the time of the announcement, atai Life Sciences, which invested in Recognify Life Sciences, was trading at a market capitalization of approximately $2.3 billion. Analysts forecast an average target price of $9.83, with a high estimate of $12.00 and a low estimate of $7.00, implying a 175.44% upside from the current price of $3.57 [2].

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