Karuna Could Submit Schizophrenia Drug to FDA by Mid-Year

BOSTON — Encouraged by positive topline results from its phase 3 trial for its new therapy for adults with schizophrenia, Karuna Therapeutics announced Monday that it is on track to submit KarXT to the Food and Drug Administration for approval by summer.

If that comes to pass, the drug treatment could launch for the treatment of patients in the second half of 2024, the company said in a press release.

Karuna Therapeutics, a clinical-stage biopharmaceutical company, said KarXT met its primary endpoint during a recent phase 3 EMERGENT-3 trial demonstrating a statistically significant and clinically meaningful 8.4-point reduction in Positive and Negative Syndrome Scale total score compared to placebo (-20.6 KarXT vs. -12.2 placebo; P < .0001) at week five (Cohen’s d effect size of 0.60). 

Consistent with prior trials, KarXT also demonstrated an early and sustained statistically significant reduction of symptoms from week two (P < .05) through the end of the trial as assessed by PANSS total score.

“KarXT has now demonstrated a robust and consistent reduction of symptoms across all three registrational trials, providing a compelling picture of the potential of KarXT in schizophrenia,” said Bill Meury, the company’s president and chief executive officer, in a written statement.

“With these data, we are one step closer to a potential treatment option that could provide the first new mechanism of action to treat schizophrenia in several decades,” he added.

Schizophrenia is a serious mental illness characterized by an individual experiencing thoughts or experiences that seem out of touch with reality, disorganized speech or behavior, and decreased participation in daily activities. 

Treatment is usually lifelong and often involves a combination of medications, psychotherapy and coordinated specialty care services.

“Despite the number of currently available treatments, there remains a significant need for new treatment options for the 21 million people living worldwide with schizophrenia,” said David Walling, Ph.D., chief clinical officer at CenExel-CNS and investigator on the EMERGENT-3 trial. 

“The results from the EMERGENT-3 trial add to the growing body of data which suggest KarXT could address the symptoms of schizophrenia without the common side effects we see with current treatment options,” Walling said.

Karuna said its new drug application for KarXT in schizophrenia will incorporate the efficacy and safety data from the three placebo-controlled registrational trials, EMERGENT-1, EMERGENT-2 and EMERGENT-3, in addition to long-term safety data from the ongoing EMERGENT-4 and EMERGENT-5 trials.

Dan can be reached at [email protected] and @DanMcCue