Karuna Therapeutics announces positive results from Phase III trial into schizophrenia

Karuna Therapeutics has announced positive topline results from its Phase III EMERGENT-2 trial, evaluating the efficacy, safety, and tolerability of KarXT (xanomeline-trospium), an oral investigational M1/M4-preferring muscarinic agonist, in adults with schizophrenia.

The trial met its primary endpoint, and KarXT demonstrated a statistically significant reduction of symptoms, as assessed by PANSS total score.

“We are thrilled that these topline results from the Phase III EMERGENT-2 trial confirm what was seen in our Phase II EMERGENT-1 trial and underscore the potential for KarXT, with its novel and unique mechanism of action, to redefine what successful treatment looks like for the 21 million people living with schizophrenia worldwide, and potentially usher in the first new class of medicine for these patients in more than 50 years,” said Steve Paul, MD, CEO, president and chairman of Karuna Therapeutics. “These results represent our second positive registrational trial. We look forward to continuing to gather long-term safety data to support our submission of a New Drug Application with the FDA for KarXT as a treatment for schizophrenia, which we expect to occur in mid-2023.”

“Despite the number of available treatment options, there continues to be a tremendous unmet need in the treatment of schizophrenia, placing an immense burden on both patients and their caregivers,” said Rishi Kakar, MD, CSO, Segal Trials and lead investigator of the Phase III EMERGENT-2 trial. “These data build on the growing body of clinical evidence supporting the potential of KarXT as a new and differentiated approach for schizophrenia, demonstrating notable improvements across both positive and negative symptoms, while not being associated with common problematic side-effects of current therapies, such as weight gain, sedation and movement disorders. This unique profile of KarXT has the potential to provide a new meaningful treatment option for our patients and their families beyond the current standard of care.”

Lina Adams