Initial results demonstrate numerical improvement of cognitive and functional measures with inidascamine across both active treatment arms compared to placebo, but did not meet statistical significance on the primary endpoint
Recognify Life Sciences, a clinical-stage biotech company focused on developing treatments for cognitive impairment, announced that its randomized, double-blind, placebo-controlled Phase 2b clinical trial evaluating inidascamine (formerly RL-007) in patients with cognitive impairment associated with schizophrenia (CIAS) did not meet its primary endpoint.
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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 at Week 6, 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.
Inidascamine 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.”
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The randomized, placebo-controlled, double-blind, Phase 2b clinical study enrolled 242 patients across the United States and Europe (NCT05686239). The trial evaluated the efficacy, safety, and tolerability of two doses of inidascamine versus placebo over a six-week treatment period. A comprehensive analysis of remaining secondary and exploratory endpoints, including subgroup analyses, is ongoing to determine whether there are identifiable responder populations or mechanistic insights that may guide future development.
Keith Nuechterlein, PhD, Distinguished Professor in the UCLA Department of Psychiatry and Biobehavioral Sciences and co-chair of the MATRICS Neurocognition Committee, commented upon seeing these results: “Developing treatments for cognitive impairment in schizophrenia is a complex challenge that requires persistence and innovation. I am encouraged by the inidascamine topline results showing consistent directional tendencies for improvement and look forward to seeing the full set of results.”
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.”
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Source – GlobeNewswire
