Amgen has discontinued both of its mid-stage lupus programs due to a lack of effectiveness during the time when all Big Pharma are holding earnings calls and conducting pipeline culls. The decision occurred just hours after Lilly made a similar choice for a Nektar Therapeutics-partnered product.
Amgen has been in the field for over forty years and is claimed to be one of the largest biotechnology companies dedicated to unlocking the promise of biology for patients suffering from severe diseases through the discovery, development, production, and delivery of novel human medicines.
According to the recent announcement by the company, the trial of rozibafusp alfa, formerly known as AMG 570, a mid-stage antibody-peptide conjugate targeted to treat systemic lupus erythematosus (SLE), the most prevalent type of lupus, has been closed. A Phase 2b research that enrolled an anticipated 320 patients and began in 2019 has been halted for futility.
A separate phase 2b research of efavaleukin alfa, formerly known as AMG 592, has also been terminated. The interleukin-2 (IL-2) mutein Fc fusion protein was also being evaluated in SLE in research that began in 2020 but was halted for the same reason, which was ineffectiveness. Amgen is still testing the IL-2 medication for ulcerative colitis in a mid-stage experiment.
The senior management of the company believes that SLE is a challenging area in drug development that will require the dedicated attention of the company to these datasets. In response to Amgen’s recent $27.8 billion acquisition of Horizon Therapeutics, Amgen EVP David Reese stated that the business is looking forward to incorporating the Horizon molecules upon the deal close to further enhance the company’s efforts to address inflammatory disease.
Horizon is conducting phase 2 studies for daxdilimab in lupus nephritis, SLE, and discoid lupus erythematosus. There is currently no cure for autoimmune illness, but authorized medicines try to control symptoms and reduce flare-ups.
Current research in the field includes Eli Lilly’s BTLA agonist antibody, LY3361237, which is being tested in a phase 2 study of SLE patients. In addition, the company will be returning the rights to rezpeg, a medication that was previously tested for lupus and atopic dermatitis. Lilly discontinued a phase 2 lupus trial evaluating the T regulatory cell stimulator therapy in February and now announced the entire surrender of rights.
Although Amgen does not have any active lupus programs in its pipeline (at least until Horizon enters the picture), the pharma has increased R&D spending by 12% this quarter, according to CEO Bob Bradway.