STALICLA is a precision molecular neuroscience clinical-stage biotech company, advancing the first precision medicine platform (DEPI) for patients with neurodevelopmental disorders (NDDs). DEPI, which has demonstrated proof-of-concept in other neurodevelopmental programs, has allowed for the identification of two distinct subgroups of patients with autism spectrum disorder and their tailored treatments STP1 and STP2. The two drugs are planned to enter Phase 2 clinical trials in 2023. STP1 and STP2 hold a multi-billion market potential.
Based at the Campus Biotech in Geneva, the nearly six-year-old company has entered an exclusive in-license agreement with Novartis to advance a late-stage drug candidate, mavoglurant (AFQ056), a selective non-allosteric metabotropic glutamate receptor 5 (mGluR5) antagonist. mGluR5 has been tied to mood disorders, addiction, and rare and common forms of Autism.
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), 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) 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 EUR 2 billion globally.
A testament to the strength of STALICLA’s neurobiology medicine platform
“This agreement with Novartis is a testament to the strength of our precision neurobiology medicine platform. We are excited about this transaction to further develop mavoglurant and bring it to the right patients,” said 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 USD 270 million, plus royalties on sales.