Promising New Data Announced on In-the-Works Schizophrenia Treatment

Karuna Therapeutics shared exciting results from a Phase 2 trial on their lead agent.

Karuna Therapeutics, a biopharmaceutical company committed to developing new therapies for patients with neuropsychiatric disorders, presented results1 from its Phase 2 EMERGENT-1 trial evaluating KarXT for the treatment of schizophrenia at the American College of Neuropsychopharmacology Annual Meeting (ACNP).

In a press conference from May of this year, Steve Paul, MD, chief executive officer of Karuna Therapeutics, had this to say on the presentation: “We look forward to presenting efficacy and safety findings from our Phase 2 study evaluating KarXT as a potential treatment option for schizophrenia, including additional new safety data on the relative rates compared to placebo and time-course of treatment emergent adverse events. These additional findings further support the potential impact of addressing schizophrenia with a new mechanism of action that has the potential to effectively treat the condition and lessen the debilitating side effects associated with the current standard of care.”2

KarXT, the company’s lead agent, has a novel action mechanism that is not mediated by dopamine or serotonin. This makes it distinct from the therapies currently available.

The presented data reinforced KarXT’s efficacy through meaningful improvements, both statistically and clinically at primary and secondary endpoints. New categorical data analysis demonstrated important differences in response rates. By week 5, the endpoint, there was a rapid separation from the placebo. 

The data also showed favorable results for KarXt’s safety and tolerability profile. The most common adverse events were only mild or moderately severe, and unassociated with discontinuing treatment.

Phase 3 trials will be conducted to evaluate KarXT in treating acute psychosis in adults, on track to initiate at end of 2020.

References

1. Brannan S, Sawchak S, Miller A, Kavanagh S, et al. The M1/M4 agonist xanomeline, in combination with the peripheral anticholinergic trospium, is effective for acute treatment of schizophrenia: results of a Phase 2 RCT comparing KarXT vs placebo. Karuna Therapeutics. Accessed December 8, 2020. https://investors.karunatx.com/static-files/2031194e-2ce9-4605-9681-199bcd7defaa

2. Karuna Therapeutics. Karuna Therapeutics to Present Additional Data from the Phase 2 Clinical Trial of KarXT for the Treatment of Psychosis in Patients with Schizophrenia at the American Society of Clinical Psychopharmacology 2020 Annual Meeting. News release. Business wire. May 27, 2020. https://www.businesswire.com/news/home/20200527005178/en/