STALICLA starts U.S. Phase 3 DDI study of STP7 (Mavoglurant) for cocaine use disorder

STALICLA SA, a biotechnology company focused on precision medicine for brain disorders, has announced a significant milestone with the commencement of its drug-drug interaction (DDI) study for STP7 (Mavoglurant), a compound licensed from Novartis. This study marks the final regulatory step in a comprehensive Phase 2 program. Upon completion, it is expected to pave the way for a Phase 3 study in the United States starting in 2025.

Lynn Durham, the CEO and Founder of STALICLA, emphasized the importance of the DDI study. It is a crucial step under their Cooperative Research and Development Agreement with the U.S. National Institute of Drug Abuse (NIDA). The anticipated Phase 3 trials for STP7, set to begin in 2025, aim to address the significant global challenge of cocaine abuse. Previous Phase 2 studies for cocaine use disorder (CUD) have shown promising results, including increased abstinence from cocaine and reduction in other dependencies such as alcohol abuse when treated with STP7 (Mavoglurant).

STALICLA is also exploring other potential therapeutic applications for STP7 (Mavoglurant) to aid patients with various central nervous system (CNS) conditions. STP7 (Mavoglurant) is currently the most clinically advanced negative allosteric modulator of the glutamate receptor 5 (mGluR5 NAM). The mGluR5 receptor has been linked to addiction, mood disorders, and neurodevelopmental disorders like Fragile X and autism spectrum disorder. Extensive clinical trials by Novartis involving over 1800 adults over two years have demonstrated the compound's safety, tolerability, and efficacy, particularly in reducing cocaine use, making STP7 a promising candidate for treating substance use and other CNS disorders.

STALICLA SA, based in Switzerland, is a clinical-stage biopharmaceutical company at the forefront of precision treatments for neurodevelopmental and neuropsychiatric disorders. The company leverages an AI-driven precision neuro medicine platform, which has led to the identification of two small molecule drug candidates for autism spectrum disorder, STP1 and STP2. These candidates are expected to enter Phase 2 trials in 2024. Additionally, following the acquisition of Mavoglurant from Novartis in 2023, STALICLA has created an advanced mGluR5 NAM platform. This platform supports extensive late-stage clinical development opportunities, thereby expanding STALICLA's capabilities to address broader unmet needs in CNS diseases.