Merck KGaA’s oral TLR7/8 inhibitor enpatoran has failed to meet the primary endpoint in a subgroup of patients, but development of the drug is set to continue.
Announced in the company’s Q4 earnings call, lupus drug enpatoran failed to meet the primary endpoint of British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (BICLA) response after 24 weeks in patients with systemic lupus erythematosus (SLE).
The randomised, double-blind, placebo-controlled WILLOW study (NCT05162586) was investigating the therapy in 456 patients with cutaneous lupus erythematosus (CLE) and SLE. The study investigated three doses, notably low, medium, and high, of enpatoran versus placebo. The full data has not yet been announced from the study.
In October 2024, Merck KGgA reported positive data from the CLE patient cohort, announcing this arm met its primary endpoint.
Despite the disappointing update, chief financial officer Helene von Roeder said that the company will continue to develop the therapy.
“We now have all the data from the WILLOW study of enpatoran, both for SLE and CLE cohorts. Even though the SLE did not meet the primary endpoint, the previous success of the CLE cohort and the previous success of certain, predefined populations in the SLE cohort, make us optimistic about the potential for further development,” said Roeder.
The diagnosed prevalent cases of SLE in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan) are projected to increase from 0.55 million in 2021 to 0.58 million in 2031, registering an annual growth rate (AGR) of 0.51%, estimates GlobalData.
If approved, GlobalData predicts sales of enpatoran to reach $85m in 2030.
GlobalData is the parent company of Clinical Trials Arena.
Studies of chimeric antigen receptor (CAR) T-cell therapies have shown promise in SLE and lupus nephritis (LN) lately. According to GlobalData’s Pharmaceutical Intelligence Centre, there are 38 CAR-T therapies in development for lupus.
Oncology pipeline update
In the earning’s call, Roeder also revealed that Merck KGgA received negative topline data from a Phase II study of ompenaclid. The Phase II trial (NCT05983367) is evaluating the drug in combination with bevacizumab and FOLFIRI (fluorouracil, irinotecan and leucovorin) in patients with metastatic colorectal cancer (MCC).
Merck KGgA gained the rights for ompenaclid in January 2024 as part of a deal with Inspirna, paying $45m upfront costs for licensing rights to the therapy. As a result of this, the company “will not exercise the US option” for the therapy.
Correction notice: All references in the article to Merck have been corrected to Merck KGaA
