Karuna Pharmaceuticals has dosed the first subject in a tolerability proof-of-concept study for its proprietary lead product. The study, which will be conducted in up to 70 healthy individuals, aims to evaluate the tolerability of KarXT (xanomeline plus trospium chloride) compared to xanomeline alone. Xanomeline is a novel, muscarinic acetylcholine receptor agonist that has demonstrated robust efficacy in treating schizophrenia and psychosis in Alzheimer’s disease; however, it has also been associated with tolerability issues that have hindered its development. By selectively targeting muscarinic receptors in the central nervous system with the KarXT approach, Karuna aims to advance xanomeline, which is exclusively licensed to Karuna, as a potential novel treatment option for patients.
Daphne Zohar, Co-Founder and Chief Executive Officer at PureTech, said: “There is a significant unmet need for treatments that can efficaciously and safely manage schizophrenia and Alzheimer’s disease. We hope to offer a solution to patients afflicted by these diseases.”