Amid a surge in research targeting cognitive disorders, the pharmaceutical industry is witnessing a wave of pivotal trial results that could reshape schizophrenia treatment paradigms. As biotech firms race to develop innovative therapies, Recognify Life Sciences steps into the spotlight with new findings from its latest clinical trial.
Recognify Life Sciences announced data from a randomized, double-blind, placebo-controlled Phase 2b trial evaluating inidascamine (formerly RL-007) in patients with cognitive impairment associated with schizophrenia (CIAS). Recognify is a strategic investment of ATAI Life Sciences N.V. (NASDAQ:ATAI).
- ATAI stock is tumbling in today’s session. Check the price action here.
The trial did not meet 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.
The company on Monday said the 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 real-world functional cognitive capacity measure.
Inidascamine was well-tolerated, with a favorable safety profile consistent with previous studies.
No evidence of sedation, weight gain, or extrapyramidal symptoms was observed, which are side effects commonly associated with schizophrenia treatments.
The study enrolled 242 patients.
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.
In November 2024, AbbVie Inc (NYSE:ABBV) stock plunged after two trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia failed two Phase 2 trials.
The studies did not meet their primary endpoint of showing a statistically significant improvement in the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score compared to the placebo group at week 6.
In September 2024, the FDA approved Bristol Myers Squibb & Co.'s (NYSE:BMY) Cobenfy (xanomeline and trospium chloride, KarXT), an oral medication for schizophrenia in adults.
Cobenfy represents the first new class of medicine in several decades and introduces a fundamentally new approach to treating schizophrenia by selectively targeting M1 and M4 receptors in the brain without blocking D2 receptors.
ATAI Price Action: ATAI Life Sciences shares were down 9.38% at $3.23 at the time of publication on Monday.
Read Next:
Photo: Shutterstock
