STALICLA SA, a clinical-stage biotech company advancing the first precision neurobiology platform for patients with neurodevelopmental disorders, has entered into an exclusive in-licensing agreement with Novartis to develop mavoglurant as a treatment for substance-use disorder and neurodevelopmental disorders (NDDs).
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 (CUD), STALICLA is now preparing to advance mavoglurant into phase 3 development for the treatment of CUD.
STALICLA will also use its precision neurobiology drug development platform (DEPI), 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, as guided by earlier clinical studies.
The market potential of the CUD and NDD indications alone could top €2 billion ($2.1 billion) globally.
Lynn Durham, STALICLA’s CEO & founder, said: “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. STALICLA stratifies patient subgroups and identifies compounds that may provide medical benefit in neurodevelopmental indications with clear unmet need.
“Our unique model benefits all healthcare stakeholders and is a key driver of the company’s rapid growth. With two phase 2 and a phase 3 trial slated to start within a year, alongside strong IP, we are well positioned to continue our exciting growth trajectory.”
Under the terms of the agreement, STALICLA has acquired worldwide rights to mavoglurant for substance-use disorders, neurodevelopmental disorders, and other indications in exchange for upfront fees and equity, and development and commercial milestones of up $270m, plus royalties on sales.
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 induces abstinence in CUD patients through inhibition of mGluR5, with no evidence of withdrawal liability.