atai Life Sciences (ATAI) company Recognify Life Sciences has reported that its Phase IIb trial of oral compound, inidascamine, to treat cognitive impairment associated with schizophrenia (CIAS) failed to achieve its primary goal.
The placebo-controlled, double-blind, randomised trial enrolled 242 subjects across Europe and the US, assessing the safety, tolerability, and efficacy of two doses of the therapy versus a placebo over six weeks.
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atai noted that the trial failed to meet statistical significance in its primary endpoint of improvements in the measurement and treatment research to improve cognition in the schizophrenia consensus cognitive battery (MCCB) neurocognitive composite score at week six.
Despite not achieving this significance, inidascamine is said to have shown consistent numerical enhancements across the complete MCCB neurocognitive composite, as well as several subdomains.
Symbol coding, processing speed and verbal learning showed modest improvements.
In addition, directionally positive impacts were observed on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT), which assesses cognitive capacity.
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By GlobalDataThe therapy was found to be well tolerated, with a safety profile in line with earlier trials.
Recognify Life Sciences co-founder and CEO Matt Pando said: “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.”
The companies also noted that there were no signs of common side effects, such as weight gain, sedation, or extrapyramidal symptoms, which are often associated with schizophrenia treatments.
Recognify is now analysing secondary and exploratory goals to identify potential responder populations or insights.
Previously known as RL-007, inidascamine is said to have been tested in more than 600 subjects across ten clinical trials, including one in CIAS.
Schizophrenia is mainly marked by delusions, hallucinations, and impaired thought processes.
