In a multimillion-dollar Swiss deal, precision molecular science biotech Stalicla has gained worldwide rights from Novartis to progress the experimental drug mavoglurant for substance-use and neurodevelopmental disorders.
The exclusive, in-licensing agreement includes undisclosed up-front fees, equity and up to $270M in development and commercial milestones, with additional royalties on sales.
The deal has breathed new life into mavoglurant, a selective non-allosteric metabotropic glutamate receptor 5 (mGluR5) antagonist. mGluR5 has been linked with mood disorders, addiction, and different forms of autism.
Novartis originally developed the drug to target the genetic disorder Fragile X syndrome but dropped its program in 2014 after disappointing clinical trials.
Now, following promising results in a phase II trial for cocaine-use disorder, Stalicla is planning to progress the experimental drug candidate into phase III development for this indication.
The company says that the market potential for cocaine-use disorder and neurodevelopmental disorders indications alone could top €2 billion globally.
In addition, Stalicla will use its proprietary neurobiology drug development technology to identify subgroups of high-responder patients.
“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 Stalicla’s CEO & founder Lynn Durham in a press statement.
“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 II and a Phase III trial slated to start within a year, alongside strong IP, we are well positioned to continue our exciting growth trajectory.”
In March, Stalicla announced successful results from a phase 1b study for the first precision medicine in autism spectrum disorder, using its lead drug candidate STP1.
The company’s drug development relies on a biotech platform driven by artificial intelligence called Databased Endophenotyping Patient Identification (DEPI).
This integrates comprehensive metabolomics—the study of metabolites with the body—with whole-genome sequencing, RNA sequencing and a proprietary ‘match module’ to pair patients’ biological signatures with drug candidates for tailored treatment options.
Stalicla says that DEPI is the first platform specifically developed to apply precision medicine in complex neurodevelopmental disorders.