Amgen (NASDAQ:AMGN) today announced it is supporting the further study of AMG 634, a phosphodiesterase type 4 (PDE4) inhibitor, for the treatment of tuberculosis (TB) and erythema nodosum leprosum (ENL), an inflammatory cutaneous and systemic complication of leprosy. Amgen acquired AMG 634 (formerly CC-11050) as part of its acquisition of Otezla® (apremilast) from Celgene in 2019. AMG 634 is currently in Phase 2 studies led by The Aurum Institute NPC (TB study) and The Leprosy Mission Nepal (ENL study).
"AMG 634 could have potential for patients suffering from ENL and TB, two diseases that continue to challenge many countries around the world," said David M. Reese, M.D. executive vice president of Research and Development at Amgen. "We believe that the right organization focused on global health will be able to help further develop the molecule and get it directly into the hands of those patients in need of treatment options."
Approximately 225,000 new cases of leprosy are identified every year1, and a significant number of leprosy patients suffer from ENL, an autoimmune complication that can occur many years after being cured of leprosy and can cause permanent nerve damage and disability2. Tuberculosis affects 10.4 million patients every year and causes over one million deaths. Current treatments are often inadequate and can leave patients with permanent, clinically significant lung damage3.
While intending to support the two Phase 2 clinical trials in ENL and TB set to begin in 2021 by providing study drug, Amgen is interested in partnering these programs with a non-government organziation (NGO) for further development.