The Phase 1b unrestricted-label, eight-week residential trial meant to assess the influence of KarXT (xanomeline-trospium) on round-the-clock ambulatory blood pressure in adults diagnosed with schizophrenia Karuna Therapeutics has just unleashed positive results. The trial, designed by FDA guidance, aimed to provide a comprehensive assessment of the potential pressure effects of KarXT over 24 hours. The results were successful in ruling out a clinically significant increase in blood pressure per FDA standards as the trial only demonstrated a mean change of -0.59 mmHg from baseline to week 8
Chief medical officer of Karuna Therapeutics, Steve Brannan. emphasized the significance of these findings, stating, “The data from the trial confirms our findings from the EMERGENT trials that suggested KarXT is not associated with a sustained increase in blood pressure in adults with schizophrenia.”
These results only amplify the findings from previous clinical data and can strengthen the New Drug Application (NDA) for KarTX. In light of the Day 120 safety update, this paints a particularly appealing picture of the cardiovascular safety profile of the drug.
The trial enrolled over 130 participants who were given flexible doses of the drug for eight weeks twice a day. The ages of participants ranged between 20-36 years and all participants had a confirmed diagnosis of schizophrenia. In a surprising turn of events, of the patients who experienced the most successful outcomes of the EMERGENT program 80% were generally those who received the highest dose level of KarXT 125/30 (125mg xanomeline/30mg trospium) twice a day.
As an investigational muscarinic antipsychotic, KarXT can offer a novel mechanism of action. KarXT can cater to the complexities of this mental illness in a more nuanced way since the treatment does not directly block dopamine receptors,
In terms of the cardiovascular safety profile of KarXT, these favorable results have done much to boost confidence in the drug. Analysts at Mizuho praised the data, asserting that KarXT appears to pose little if any, worrisome cardiovascular risk. The results not only affirmed their confidence but also solidified their bullish view on the prospects of KarXT, for which they model peak sales exceeding $6 billion.
The unveiling of these results places Karuna Therapeutics at the forefront of the race to market. The biotech intends to incorporate the blood pressure data into its FDA approval filing, with management assuring that the update won’t impede the regulatory process. As a result, preparations for the product launch are proceeding, with expectations of introducing KarXT to the market in the second half of the upcoming year.
