August 31, 2020 -- Provention Bio has begun a phase IIB study of PRV-015, an anti-interleukin-15 (IL-15) monoclonal antibody (mAb), in adult patients with nonresponsive celiac disease (NRCD). The drug is being developed in collaboration with Amgen as potentially the first approved therapeutic for celiac disease.
PRV-015 binds and inhibits the proinflammatory cytokine IL-15 and has been identified as a major mediator in the pathophysiology of celiac disease.
The clinical trial is a placebo-controlled, double-blind, randomized study to examine the efficacy and safety of three dose levels of PRV-015, administered every two weeks for six months. The trial is expected to enroll approximately 220 adults with NRCD across approximately 40 sites in the U.S., Canada, and Europe.
The development of PRV-015 began in 2018 under an agreement with Amgen in which Provention conducted and funded the phase IIB trial and Amgen would be responsible for manufacturing the product. Upon completion of the clinical trial, Provention will be eligible to receive a $150 million milestone payment, as well as additional regulatory milestone payments and royalties if Amgen continues the development of the product.