STALICLA signs exclusive in-licensing agreement with Novartis for late-stage clinical neuropsychiatric and neurodevelopmental disorder treatment

STALICLA SA, a clinical-stage, Geneva-based, biotech company advancing the first precision neurobiology platform for patients with neurodevelopmental disorders, announces that it 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 highly promising results from a Phase 2 study conducted with mavoglurant in cocaine-use disorder (CUD; NCT03242928), STALICLA is now preparing to advance mavoglurant into Phase 3 development for the treatment of CUD.

In parallel, STALICLA will leverage 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 globally.

“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 is able to stratify patient subgroups and identify 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.” says Lynn Durham, STALICLA’s CEO & Founder.

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.

About Mavoglurant

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.

About STALICLA

STALICLA is a precision molecular neuroscience clinical stage biotech company, advancing the first precision medicine platform (DEPI) for patients with neurodevelopmental disorders (NDDs), and neuropsychiatric disorders.

STALICLA’s unique approach is addressing the poor construct validity of behaviourally defined disorders through its unique platform integrating molecular data with human genetic information to create testable clinical hypotheses in psychiatry and neuroscience.

With multiple clinical proof of concepts, DEPI has allowed for the identification of two distinct subgroups of patients with Autism Spectrum Disorder and their tailored treatments STP1 and STP2, both of which are planned to enter Phase 2 clinical trials in 2023. STP1 and STP2 hold a multi-billion market potential.

The DEPI platform has been validated in a clinical setting showing high specificity, sensitivity and positive predictive value in prospectively designed trials recalling ‘high’ responder patients to previously failed drug candidates.

STALICLA is currently preparing its next stage of growth to advance its pipelines and scale its platform towards revenue generation.