Galapagos says out with the old, in with the new, as respiratory drug sent back to Molecure

While Galapagos is stocking its pipeline by way of two acquisitions, the biotech is also cleaning house, sending the rights for a respiratory disease drug back to Molecure.

The decision to move on from OATD-01 comes as Galapagos embarks on a transition under the purview of new CEO Paul Stoffels, M.D. Earlier this week, the company finally revealed its new strategy with the purchase of two small biotechs and a new push into CAR-T therapies. The company was in need of a turnover after its late-stage pipeline crumbled in the clinic.

As part of that overhaul, Galapagos is conducting an “ongoing strategic exercise to renew and accelerate our portfolio,” according to Andre Hoekema, Ph.D., chief business officer, and OATD-01 did not make the cut.

Warsaw, Poland-based Molecure has regained the rights to the therapy after an 18-month partnership with Galapagos. Molecure will hang on to a nonrefundable payment of 27 million euros ($28.4 million) made by Galapagos when the partnership was originally signed in November 2020.

The therapy is aimed at several respiratory indications, according to Molecure CEO Marcin Szumowski, but the company will now prioritize development in the rare inflammatory disease sarcoidosis. Even though the partnership was short, Molecure believes the data gleaned from the work with Galapagos support the advancement of OATD-01 into a phase 2 trial.

Should Molecure get a positive result from that study once it gets going, the company hopes a new partnership might come to fruition to support further development in sarcoidosis. The disease causes small lumps of inflammatory cells to collect in the lungs, which can change the structure of the lungs and impact breathing.

“Data generated to date reveal an attractive benefit-risk profile for this asset, and we look forward to revising our clinical strategy for the further development and subsequent partnering of this program in the near future,” Szumowski said in a statement.

OATD-01 is a dual chitinase inhibitor that has been shown in preclinical testing to decrease the disease burden of animal models with sarcoidosis. Molecure plans to detail next steps for the therapy in the coming weeks. The company also has a dual arginase inhibitor for different types of cancer called OATD-02 that is expected to move into phase 1 study in the fourth quarter.