R&D, Startups

GSK punts a failed cardio drug to a biotech startup — which has a new development strategy in mind

More than 3 years after losmapimod proved to be a turkey in a late-stage cardio study at GlaxoSmithKline, the drug has been dusted off and handed over to a startup, which has some new plans in mind for this therapy.

Researchers at Fulcrum have been probing the role that the DUX4 gene plays in triggering rare cases of facioscapulohumeral muscular dystrophy. They concluded that a selective p38α/β MAPK inhibitor could do the job on DUX4, and GSK had one on the back shelf it hadn’t touched in years.

Cambridge, MA-based Fulcrum Therapeutics handed over a “high single-digit” equity stake in the company for the drug, with an unspecified set of milestones and royalties on the table.

The drug never made it past the interim review process at GSK, which had set out to see if its p38 inhibitor — designed to tamp down on an enzyme associated with acute inflammation and cell damage — could improve outcomes for cardio patients. But that did give them an excellent perspective on the safety of the drug, as well as its ability to hit the target.

Now Fulcrum execs say they’ll hustle the therapy straight into a Phase IIb trial for the rare disease.

The drug has been on the shelf since 2015, and the new R&D execs in control — who are intent on building a pipeline of cancer drugs — seemed happy to pass it along to Fulcrum.

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