Amgen cuts lupus programs for futility hours after Lilly officially walks away from one, too

In a day chock-full of Big Pharma earning calls and accompanying pipeline culls, Amgen is no exception, slicing both of its mid-stage lupus programs for futility. The decision came hours after Lilly did the same for a Nektar Therapeutics-partnered asset.

On the chopping block at Amgen is a study of rozibafusp alfa, formerly dubbed AMG 570, a mid-stage antibody-peptide conjugate designed to treat systemic lupus erythematosus (SLE)—the most common form of lupus. A phase 2b study that enrolled an estimated 320 patients and launched in 2019 has been stopped “for futility,” according to an April 27 release.

The other immunology program to be cut is a separate phase 2b study of efavaleukin alfa, formerly known as AMG 592. The interleukin-2 (IL-2) mutein Fc fusion protein was also being assessed in SLE in a study launched in 2020, which has also been discontinued for the same reason—futility. Amgen continues to evaluate the IL-2 drug in a mid-stage trial for ulcerative colitis.

“SLE remains a challenging area for drug development, one that will be an area of focus for us as we further explore these datasets to advance our knowledge in the field,” David Reese, M.D., Amgen’s EVP of R&D, said during an April 27 first quarter earnings call. Referencing Amgen’s recent $27.8 billion buy of Horizon Therapeutics, Reese said the company is “looking forward to incorporating the Horizon molecules upon deal close to further enhance our efforts to address inflammatory disease.”

Horizon is developing daxdilimab in phase 2 trials for lupus nephritis, SLE and discoid lupus erythematosus.

There currently isn’t a cure for the autoimmune disease, but approved treatments aim to manage symptoms and minimize flare-ups.

Current work in the space includes Eli Lilly’s BTLA agonist antibody, known as LY3361237, which is being studied in a phase 2 trial of patients with SLE. The Big Pharma also announced today that it was handing the rights to rezpeg back to Nektar, a drug that was previously being studied in lupus and atopic dermatitis. Lilly dropped a phase 2 lupus trial assessing the T regulatory cell stimulator treatment back in February and announced the total return of rights today.

Amgen may not have any active lupus programs in its pipeline—at least until Horizon comes into the fold—but the pharma has overall boosted R&D spend 12% this quarter, according to CEO Bob Bradway.