Recognify's Inidascamine Trial Falls Short of Primary Endpoint, Shows Promising Safety Profile

Recognify Life Sciences announced that its Phase 2b trial for inidascamine in patients with cognitive impairment associated with schizophrenia did not meet its primary endpoint. However, inidascamine showed modest numerical improvements in multiple neurocognitive subdomains and real-world functional capacity measures. The drug was well-tolerated with no evidence of sedation, weight gain, or extrapyramidal symptoms, which are common side effects of treatments for schizophrenia.

Recognify Life Sciences, a subsidiary of atai Life Sciences (NASDAQ:ATAI), recently announced that its Phase 2b clinical trial for inidascamine in treating cognitive impairment associated with schizophrenia (CIAS) did not meet its primary endpoint. The study, involving 242 patients across the US and Europe, showed modest numerical improvements in cognitive and functional measures. Despite not achieving statistical significance, inidascamine demonstrated consistent improvement across multiple cognitive domains and maintained a favorable safety profile with no sedation, weight gain, or extrapyramidal symptoms.

The trial, a randomized, double-blind, placebo-controlled study, tested two doses of inidascamine over six weeks. While the study did not achieve statistical significance on its primary endpoint of improvement on the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) neurocognitive composite score, inidascamine demonstrated a modest but consistent numerical improvement across the overall MCCB neurocognitive composite and multiple individual subdomains, including Symbol Coding, Speed of Processing, and Verbal Learning (immediate recall). Directionally positive effects were also observed on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT), a measure of real-world functional cognitive capacity.

The drug was well-tolerated, with a favorable safety profile consistent with previous studies. Importantly, no evidence of sedation, weight gain, or extrapyramidal symptoms was observed, which are side effects commonly associated with treatments used in people living with schizophrenia. Matt Pando, PhD, Chief Executive Officer 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 as well as replication on specific subsets of the cognitive measures; namely, symbol coding and verbal memory. These findings reinforce our commitment to addressing the significant unmet needs of cognitive impairment associated with numerous 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.”

Recognify plans to present additional results from the study at upcoming scientific meetings and will continue to evaluate strategic options for inidascamine based on the totality of data. Srinivas Rao, MD, PhD, Chief Executive Officer and Co-Founder of atai Life Sciences, added, “CIAS remains a challenging therapeutic area with a significant unmet need. While we believe these results support the continued development of inidascamine by Recognify for CIAS as well as its potential application in other indications, as previously communicated, we intend to allocate atai’s resources on our wholly owned pipeline of transformative psychedelic product candidates focused on affective disorders.”

Recognify Life Sciences is a clinical-stage biotech company on a mission to provide pro-cognitive treatments solutions to mental health and neurodegenerative disorders. The company is a strategic investment of atai Life Sciences. For more information about Recognify, please visit [Recognify Life Sciences](https://www.recognify.life).

References:
[1] https://www.stocktitan.net/news/ATAI/recognify-life-sciences-provides-update-on-phase-2b-trial-of-yc4zk62tc15h.html