STALICLA Launches DDI Study for STP7 Phase 3 Trials in Cocaine Addiction Treatment

Switzerland-based STALICLA SA, a biotech firm focused on precision medicine for neurological conditions, has reached a significant milestone with the commencement of the First Patient First Visit (FPFV) for a drug-drug interaction (DDI) study of STP7, also known as Mavoglurant. This compound is a mGluR5 negative allosteric modulator, a class of drugs that has shown promise in treating various brain disorders. The DDI study is a crucial regulatory step that, upon completion, will pave the way for Phase 3 trials in the United States, scheduled for 2025.

STALICLA's CEO and Founder, Lynn Durham, highlighted the importance of this study, noting that it is a key step in fulfilling the company's agreement with the U.S. National Institute of Drug Abuse (NIDA). The aim is to address the significant global health issue of cocaine abuse. The Phase 2 studies for cocaine use disorder (CUD) have yielded remarkable results, with STP7 demonstrating significant efficacy in increasing abstinence rates and reducing co-morbid dependencies, such as alcohol abuse.

STP7 (Mavoglurant) is distinguished as the most clinically advanced mGluR5 NAM, with potential applications beyond addiction. The receptor's role in mood and neurodevelopmental disorders, including Fragile X syndrome and autism spectrum disorder, makes STP7 a candidate for treating a range of CNS conditions. Previous clinical trials by Novartis involving over 1800 adults have shown STP7 to be safe, well-tolerated, and effective in reducing cocaine use.

STALICLA is also at the forefront of developing precision treatments for neurodevelopmental and neuropsychiatric disorders. The company's AI-driven platform has identified two drug candidates, STP1 and STP2, for autism spectrum disorder, with plans to advance to Phase 2 trials in 2024. The acquisition of Mavoglurant from Novartis in 2023 has bolstered STALICLA's mGluR5 NAM platform, expanding its potential to address a broader spectrum of CNS diseases.