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Investing.com -- ATAI Life Sciences BV (NASDAQ:ATAI) stock tumbled 17.8% after the company announced that a Phase 2b clinical trial for inidascamine, a treatment for cognitive impairment associated with schizophrenia (CIAS), failed to meet its primary endpoint.
The trial, conducted by ATAI’s portfolio company Recognify Life Sciences, did not achieve statistical significance on the primary measure of improvement on the MCCB neurocognitive composite score at Week 6. Despite the setback, the drug showed modest numerical improvements across multiple cognitive domains and demonstrated a favorable safety profile without common side effects like sedation or weight gain.
Matt Pando, CEO of Recognify Life Sciences, acknowledged the disappointment but highlighted "consistency of improvement signals across multiple cognitive and functional measures." The company plans to analyze the full data set to determine potential next steps for the program.
The randomized, placebo-controlled study enrolled 242 patients across the United States and Europe, evaluating two doses of inidascamine versus placebo over six weeks. Recognify intends to present additional results at upcoming scientific meetings.
Srinivas Rao, CEO of ATAI Life Sciences, noted that while these results support continued development of inidascamine, ATAI plans to focus its resources on its "wholly owned pipeline of transformative psychedelic product candidates focused on affective disorders," as previously communicated.
CIAS remains a challenging therapeutic area with significant unmet medical needs, and the company is continuing to evaluate strategic options for the drug based on the complete data analysis.
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