Novartis has kept the faith in mavoglurant even after the therapy flunked a trial in a genetic disorder, and, now, fellow Swiss drug developer Stalicla has signed off on $270 million in biobucks to take the asset into phase 3.
Mavoglurant is designed to inhibit selective negative allosteric modulator of the metabotropic glutamate receptor 5 (mGluR5), which has been tied to mood disorders, addiction and various forms of autism. Novartis originally developed mavoglurant for a genetic disorder called fragile X syndrome before dropping the program in 2014 after it failed in the clinic. But in recent years, the Big Pharma has spied new potential opportunities for the drug, most recently putting it through phase 2 trials for cocaine use disorder (CUD).
The results of that midstage trial showed that mavoglurant induces abstinence in CUD patients with no evidence of withdrawal liability, a readout that Stalicla described as “highly promising.” Now, the biotech wants to continue the drug’s journey into phase 3 studies, according to the biotech's Jan. 9 release.
But that’s not all. Stalicla plans to harness its own precision neurobiology drug development platform to identify “subgroups of high responder patients with rare and common neurodevelopmental disorders where mavoglurant can be an effective treatment, as guided by earlier clinical studies.”
While not providing a breakdown of the payments involved, Stalicla did say that the upfront fees, equity and milestone payments in the deal could potentially total $270 million on top of royalties. From the biotech’s point of view, the prize at stake is a worldwide market for both CUD and neurodevelopmental indications it claims is worth over 2 billion euros ($2.14 billion).
Stalicla describes itself as a precision molecular neuroscience biotech, which uses its platform to "integrate molecular data with human genetic information to create testable clinical hypotheses in psychiatry and neuroscience." Mavoglurant will join a pipeline consisting of two candidates for patients with autism, which the company hopes to enter into phase 2 trials this year.
It’s a link that makes sense in the context of Novartis’ original plans for the drug. Fragile X syndrome is a genetic condition that causes a range of developmental problems including learning disabilities and cognitive impairment, with around one-third of individuals with the syndrome having features of autism spectrum disorder.
“Stalicla stratifies patient subgroups and identifies compounds that may provide medical benefit in neurodevelopmental indications with clear unmet need,” CEO Lynn Durham explained in the release. “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.”