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

KarXT was generally well tolerated, with overall discontinuation rates similar to placebo (KarXT 25% vs. placebo 21%). Discontinuation rates due to treatment-emergent adverse events (TEAEs) were also similar between KarXT and placebo (7% vs. 6%, respectively). The most common KarXT TEAEs (≥5% and at least twice the rate of placebo) were constipation, dyspepsia, nausea, vomiting, hypertension, dizziness, and gastroesophageal reflux disease (acid reflux). The majority of common TEAEs occurred in the first two to three weeks of treatment, were transient, and resolved before the end of the trial (week 5). The data from EMERGENT-2 suggests that KarXT may have a distinctive safety and tolerability profile, as it was not associated with many of the adverse events typically associated with current antipsychotic treatments, including somnolence, weight gain and extrapyramidal motor symptoms.

“Coming off the heels of our NDA acceptance of KarXT for the treatment of schizophrenia, this publication in The Lancet further validates KarXT’s potential as an alternative to currently available treatment options that block dopamine receptors,” said Inder Kaul, MD, MPH, senior vice president of clinical development at Karuna Therapeutics and lead author of the manuscript. “For the first time in decades, a potential new therapeutic option presents the possibility of treating schizophrenia symptoms, perhaps without the burden of many of the side effects commonly associated with current antipsychotics.”

“New treatments and novel mechanisms are urgently needed for people with schizophrenia because many don’t respond to their therapy and others only have a partial improvement in symptoms or intolerable side effects,” said Rishi Kakar, M.D., chief scientific officer and medical director of Segal Trials, an author of the manuscript, and lead investigator of the Phase 3 EMERGENT-2 trial. “The antipsychotic activity and differentiated safety and tolerability profile demonstrated in EMERGENT-2, and the other completed EMERGENT trials, provide hope to the healthcare community and patients that KarXT may provide a much-needed new way to treat those living with schizophrenia.”