RARE Daily

Stalicla Sees Potential In Failed Novartis Drug for Neurodevelopmental Disorders

January 10, 2023

Stalicla has entered into an exclusive in-licensing agreement with Novartis for a failed experimental therapy for fragile-X mavoglurant as a treatment for substance-use disorder and neurodevelopmental disorders for up to $270 million.

Photo: Lynn Durham, Stalicla’s CEO and founder

Mavoglurant is a selective non allosteric metabotropic glutamate receptor 5 (mGluR5) antagonist. mGluR5 has been tied to mood disorders, addiction, as well as rare and common forms of autism. In clinical phase 2 studies, mavoglurant induced abstinence in cocaine use disorder patients through inhibition of mGluR5, with no evidence of withdrawal liability.

Mavoglurant has previously been tested in more than 1,800 patients and demonstrated a good safety and tolerability profile. Following promising results from a phase 2 study conducted with mavoglurant in cocaine-use disorder, Stalicla is now preparing to advance mavoglurant into phase 3 development for the treatment of CUD.

Stalicla said it will leverage its precision neurobiology drug development platform, which has demonstrated proof-of-concept in other neurodevelopmental programs, to detect subgroups of high responder patients with rare and common neurodevelopmental disorders where mavoglurant can be an effective treatment.

“This agreement with Novartis is a testament to the strength of our precision neurobiology medicine platform and we are excited about this transaction to further develop mavoglurant and to bring it to the right patients,” said Lynn Durham, Stalicla’s CEO and founder. “Stalicla is able to stratify patient subgroups and identify compounds that may provide medical benefit in neurodevelopmental indications with clear unmet need.”

The companies did not release details of their financial agreement beyond saying that in exchange for worldwide rights to mavoglurant for substance-use disorders, neurodevelopmental disorders, and other indications, Stalica will pay upfront fees, equity, and development and commercial milestones of up $270 million, plus royalties on sales.

Author: Rare Daily Staff

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