Atai and Recognify's schizophrenia drug fails to meet main goal in trial
U.S.-listed shares of atai dropped about 17% in extended trading.
The trial enrolled 242 patients with cognitive impairment associated with schizophrenia (CIAS), which affects memory, attention and decision-making in people with the mental illness.
Recognify said patients taking the drug, inidascamine, showed some improvement in cognitive tests compared with a placebo, but the results were not statistically significant.
Despite the drug missing the main goal, Recognify said patients on inidascamine showed consistent signs of improvement in areas such as processing speed and verbal learning, with positive trends on a test assessing real-world cognitive abilities.
The drug was well-tolerated, with no signs of sedation, weight gain, or movement-related side effects, which are common with existing schizophrenia treatments.
CIAS remains one of the most challenging and underserved areas in mental health, with no FDA-approved treatments.
Atai and Recognify's setback adds to a string of failures in CIAS drug development, including last year's decision by Neurocrine Biosciences (NBIX.O), opens new tab to halt its own CIAS drug program after disappointing results.
Cognitive deficits affect about 80% of people with schizophrenia, a condition that impacts roughly 24 million individuals globally, according to the World Health Organization.
Standard treatment for schizophrenia typically involves antipsychotic medications that help manage hallucinations and delusions, but often do not address cognitive symptoms.
Recognify, which is majority-owned by Berlin-based Atai, said it will continue to analyze full trial results and present further data at upcoming scientific meetings.
Atai said it intends to focus resources on its own pipeline of psychedelic-based therapies for mood-affecting disorders, while continuing to support Recognify's efforts.
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