Karuna Therapeutics Announces The Lancet Publication of Data from Phase 3 EMERGENT-2 Trial Evaluating KarXT in Schizophrenia

Karuna Therapeutics, Inc. (NASDAQ: KRTX), a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced that results from the Phase 3 EMERGENT-2 trial of KarXT (xanomeline-trospium) in adults with schizophrenia were published in The Lancet. The manuscript shares KarXT data showcasing a clinically meaningful and statistically significant reduction in positive and negative symptoms of schizophrenia among adult patients experiencing acute psychosis, alongside a distinct tolerability profile.

“Having such robust data showcased in one of the world’s most prestigious medical journals attests to the potential of KarXT’s novel mechanism of action to redefine the treatment landscape for the millions grappling with schizophrenia’s disabling symptoms,” said Steve Paul, M.D., president of research and development and chief scientific officer of Karuna Therapeutics and co-author on the manuscript. “The data published in our manuscript continue to reinforce our confidence in KarXT as we look ahead to the results of our ongoing trials, including EMERGENT-4 and EMERGENT-5, which will provide a longer-term view of the efficacy and safety of KarXT in people living with schizophrenia.”

The Phase 3 EMERGENT-2 trial was a double-blind, placebo-controlled, five-week inpatient trial that enrolled 252 adults with schizophrenia in the United States. Participants were randomized 1:1 to receive a twice-daily, flexible dose of KarXT or placebo. In the trial, KarXT demonstrated a statistically significant and clinically meaningful 9.6-point reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo (-21.2 KarXT vs. -11.6 placebo, p<0.0001) at week 5, the primary outcome measure of the study. Results published in The Lancet also include data for all the pre-specified secondary outcome measures: change in PANSS positive subscale, PANSS negative subscale, PANSS Marder negative factor, Clinical Global Impression-Severity score, and percentage of participants achieving a ≥30% reduction from baseline to week 5 in PANSS total score, where KarXT demonstrated statistically significant reductions compared to placebo at week 5 (p<0.05) on each endpoint.