STALICLA attracts US partner for Phase 3 development of anti-cocaine drug

STALICLA SA is a clinical-stage biotech startup advancing the first precision neurobiology platform (DEPI) for patients with neurodevelopmental and neuropsychiatric disorders. Early this year, the startup expanded its portfolio by acquiring Norvatis’ drug candidate, mavoglurant, a treatment for substance-use disorders and neurodevelopmental disorders (NDDs), in return for undisclosed late-stage milestone payments and royalties. Novartis has also taken an equity stake in STALICLA.

Mavoglurant is the most clinically advanced selective negative allosteric metabotropic glutamate receptor 5 (mGluR5). mGluR5 has been tied to mood disorders, addiction as well as rare and common forms of Autism. In clinical Phase 2 studies, mavoglurant has been shown to induce abstinence in cocaine use disorder patients through inhibition of mGluR5, with no evidence of withdrawal liability.

The company has signed a Cooperative Research and Development Agreement (CRADA) with the US National Institute on Drug Abuse (NIDA), the lead federal agency supporting scientific research on drug use and addiction to improve individual and public health. Under the terms of the agreement, NIDA will cover, under its own account, the Phase 3 trial for mavoglurant, which is slated to enrol up to 330 patients.

“Our CRADA with NIDA allows us to enter into late-stage development and is a testament to STALICLA’s commitment to bringing new treatments to patients suffering from neuropsychiatric and neurodevelopmental disorders”, said Lynn Durham, STALICLA’s Founder & CEO. It is also a validation of mavoglurant’s potential in treating patients with substance-abuse disorders. We have onboarded an exceptional partner in NIDA, and we are excited about working together to accelerate mavoglurant towards a new drug application.”

(Press release/RAN)