atai Life Sciences (NASDAQ:ATAI, ETR:9VC) said on Friday that its platform company, Recognify Life Sciences, reported top-line results from a Phase 2b trial of inidascamine in cognitive impairment associated with schizophrenia (CIAS), which did not meet the primary endpoint but demonstrated consistent signs of cognitive and functional benefit and maintained a favorable safety profile.
The double-blind, placebo-controlled study enrolled 242 patients and tested two doses of inidascamine over a six-week treatment period.
While the trial did not reach statistical significance on the MCCB neurocognitive composite score at Week 6, inidascamine showed numerical improvements across the composite as well as key subdomains, including symbol coding, speed of processing, and verbal learning.
Directionally positive effects were also observed on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT), a measure of functional cognitive capacity.
"CIAS remains a challenging therapeutic area with significant unmet need," said Srinivas Rao, CEO of atai Life Sciences.
"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."
Importantly, inidascamine was well-tolerated with no evidence of sedation, weight gain, or extrapyramidal symptoms — adverse effects commonly seen with existing treatments for schizophrenia.
atai holds a 52% stake in Recognify and emphasized that, consistent with its strategic focus, it plans to prioritize resources on its wholly owned pipeline of next-generation psychedelic therapeutics aimed at addressing treatment-resistant mental health conditions.
Jefferies analysts, who had low expectations for success in the high-risk CIAS space, noted that the outcome is unlikely to materially impact atai’s valuation. The firm highlighted positive momentum across atai’s psychedelic portfolio, particularly BPL-003 (intranasal 5-MeO-DMT), which has already demonstrated rapid and durable effects in treatment-resistant depression.
atai is preparing for additional BPL-003 data from its open-label extension and two-dose induction study, as well as potential FDA breakthrough therapy designation. Other wholly owned assets such as EMP-01 (R-MDMA) and VLS-01 (buccal film DMT) are also advancing toward Phase 2 data in 2026.