In a 242-patient Phase 2b trial for cognitive impairment associated with schizophrenia (CIAS), inidascamine (formerly RL-007) failed to meet its primary endpoint. The study did not achieve statistical significance on the MCCB neurocognitive composite score at Week 6, despite consistent numerical trends favoring treatment over placebo across several subdomains.
While the topline data showed no meaningful difference in the primary efficacy outcome, modest improvements were seen in individual domains including verbal learning, symbol coding, and processing speed. Functional assessments using the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) also showed directional benefits in treated arms. However, none of these findings reached statistical significance, and a full dataset — including secondary endpoints and subgroup analyses — has yet to be disclosed.
The result marks a setback for Recognify Life Sciences and its parent company atai Life Sciences, which has been exploring non-psychedelic neurocognitive compounds alongside its psychedelic-based mental health pipeline. CIAS remains an area of high unmet need with no approved pharmacologic treatments, but the trial’s outcome reinforces the complexity of demonstrating cognitive improvement in schizophrenia using standardized neuropsychological tools.
The trial’s safety profile may offer a partial consolation. Inidascamine was well tolerated, with no sedation, weight gain, or extrapyramidal symptoms observed — side effects that frequently limit use of current schizophrenia therapies. This clean safety readout may support further exploration of the drug in different subpopulations or related neuropsychiatric indications, depending on how secondary data unfolds.
Strategically, atai has already signaled its intent to deprioritize inidascamine in favor of wholly owned psychedelic candidates focused on affective disorders. Unless Recognify identifies a compelling responder subgroup or gains regulatory traction through exploratory endpoints, the asset may face diminishing internal support. Nonetheless, the drug’s mechanistic profile — targeting cholinergic, glutamatergic, and GABA-B pathways — could appeal to external partners seeking to diversify cognitive treatment approaches.
The broader challenge for the field remains clear: cognitive symptoms in schizophrenia are persistent, heterogeneous, and difficult to measure with precision in short-duration studies. Without validated surrogate endpoints or digital biomarkers, sponsors face continued risk of missing signal in otherwise promising candidates.
Recognify plans to present full results at future scientific meetings. Whether the upcoming analyses will reshape the asset’s trajectory or confirm the topline result as definitive remains to be seen. For now, the company is navigating a familiar dilemma in neuropsychiatric development — how to extract strategic value from directional but statistically inconclusive data.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
