Long-term treatment with Bristol Myers Squibb's experimental schizophrenia drug, KarXT, was associated with continued improvements in symptoms, according to new interim results from the phase 3 EMERGENT-4 trial.
In the interim analysis, presented at the Annual Congress of the Schizophrenia International Research Society, KarXT was associated with significant improvement in symptoms of schizophrenia across all efficacy measures at 52 weeks. The analysis included 110 patients, with 29 patients having completed 52 weeks of treatment.
At the end of the open-label extension, more than 75% of participants achieved >30% improvement in symptoms, with an average reduction of 33.3 points from baseline, as measured by the Positive and Negative Syndrome Scale total score.
According to BMS, the drug also demonstrated a favorable impact on weight and long-term metabolic profile.
The results are great news for BMS, having recently snatched up the promising treatment in late 2023 through its $14 billion acquisition of Karuna Therapeutics.
KarXT is a potentially revolutionary schizophrenia treatment, marking the first major pharmacological innovation in the field in decades. The orally administered drug uniquely targets M1/M4 muscarinic receptors, diverging from traditional treatments by avoiding dopamine and serotonin pathways. This dual-action strategy seeks to exploit xanomeline's benefits while mitigating side effects with trospium, potentially introducing a unique treatment option for severe mental health conditions.
KarXT currently has a PDUFA date of September 26, 2024.
