Karuna Therapeutics has achieved a major milestone in its mission to bring a revolutionary new treatment for schizophrenia to the public: the results of its Phase III EMERGENT-3 trial have revealed that KarXT (xanomeline-trospium) has successfully met its primary endpoint, leading to a significant and clinically meaningful improvement in symptom severity. It marks a major success for the company, completing a hat-trick of successful trials.
After five weeks of treatment, patients in the KarXT arm experienced remarkable improvement in their symptoms of schizophrenia as evidenced by a 20.6 point reduction on the Positive and Negative Syndrome Scale (PANSS). This impressive result was notably greater than the 12.2 point reduction seen in the placebo comparator group.
The study revealed a difference of 8.4 points between the two groups, which was both statistically significant and clinically meaningful. This finding was an exciting breakthrough that has the potential to make a real impact on the health of patients.
KarXT was found to be highly effective in reducing the symptoms of schizophrenia, as evidenced by significant improvements in both the positive and negative symptoms as measured by the PANSS subscales. These findings suggest that KarXT could be an effective and safe treatment option for those suffering from this debilitating disorder.
Remarkably, the positive effects of KarXT treatment became visible just two weeks after beginning the regimen, and these beneficial effects lasted until the conclusion of the study.
The EMERGENT-3 study was an innovative double-blinded and placebo-controlled trial that sought to uncover the potential of KarXT as a therapy for psychosis in adult schizophrenia patients. 256 participants took part in the trial, which not only looked at the efficacy of the candidate but also its safety and tolerability. The results were encouraging, demonstrating the promise of KarXT as a potential therapy.
The KarXT arm of the study saw a 70% rate of treatment-emergent adverse events, while the placebo arm saw a 50% rate. Furthermore, 6% of patients in the KarXT arm dropped out of the study due to these toxicities, compared to just 5% in the placebo arm.
Karuna’s third successful clinical trial of KarXT for the treatment of schizophrenia has reaffirmed its efficacy, safety, and tolerability. In a Monday morning investor call, Karuna’s President and CEO Bill Meury expressed his enthusiasm for the positive results, solidifying the company’s continued commitment to providing innovative treatments for this debilitating disorder.
The promising results of this study offer a much-needed new treatment option. Dr. Meury is hopeful that this could be a viable solution for those suffering from this condition.
If approved, KarXT would be a revolutionary breakthrough in the treatment of schizophrenia, marking the first therapy to specifically target and treat the negative symptoms of the disorder. With its potential to significantly improve the quality of life of those living with schizophrenia, KarXT could be a game-changer in the world of mental health.
Looking Ahead to Launch
Karuna Therapeutics is on track to submit a New Drug Application for KarXT to the US Food and Drug Administration (FDA) by mid-2023, based on data from EMERGENT-3 and two earlier successful studies. If approved, the groundbreaking treatment could be available to patients as early as the second half of 2024.
In February 2021, Karuna made a groundbreaking announcement when they published the results of their Phase II registrational study, EMERGENT-1, in The New England Journal of Medicine. The results showed that KarXT, administered twice-daily over five weeks, led to an impressive 11.6-point drop in PANSS score compared to the placebo group. This is a major milestone for the company, and could potentially revolutionize the treatment of mental health conditions.
KarXT treatment has been proven to yield remarkable results in managing schizophrenia symptoms, both positive and negative, as well as reducing clinician-rated disease severity. These positive outcomes demonstrate the efficacy of the treatment in helping to manage the disorder.
In August 2022, Karuna released a groundbreaking report from their third registrational study, the Phase III EMERGENT-2 trial. Results showed that both the twice-a-day and flexible dosing regimens of KarXT were incredibly effective, significantly reducing PANSS scores by nearly 10 points more than placebo after just five weeks of use. This is a major breakthrough for the treatment of mental health conditions.
Karuna Pharmaceuticals is taking their research to the next level with the EMERGENT-4 and EMERGENT-5 trials. These Phase III trials are looking into the long-term safety and efficacy of their innovative drug, KarXT. By pushing the boundaries of medical research, Karuna is paving the way for a better future in healthcare.