Data from a mid-stage study showed that Provention Bio Inc.'s drug PRV-6527 failed to improve the symptoms of patients with Crohn's disease, an inflammatory bowel disease.
The phase 2a study, called Prince, evaluated PRV-6527 in 93 patients with moderate-to-severe Crohn's disease who had either not received any previous biologic treatment for their condition or had failed on at least one biologic drug. Results showed no difference between PRV-6527 and placebo at the 12th week of treatment, indicating that the study failed to meet its main goal.
Crohn's disease is a chronic, immune-mediated inflammatory bowel disease that causes inflammation of the gastrointestinal tract, leading to abdominal pain, diarrhea, fatigue and weight loss.
The clinical trial's primary goal was a change in Crohn's disease activity at week 12. Provention said patients who received PRV-6527 showed substantial improvement, but the placebo score was similar, according to an Oct. 22 press release. The company said the high placebo response rate may have been attributable to background medication used in the 85% of patients in the trial who had not received a biologic drug before.
Biologic therapies, which are made from biologic material, have emerged as a new treatment option for Crohn's disease, according to the Crohn's & Colitis Foundation. These drugs stop certain proteins in the body from causing inflammation. Previous therapies for this condition include corticosteroids, which can affect a patient's entire body and cause serious side effects, while biologics are more targeted.
PRV-6527 was found to be generally safe and well received, and no drug-related adverse side effects were reported.
Oldwick, N.J.-based Provention said data from the Prince trial showed that PRV-6527 was able to intercept the migration of inflammatory cells to the gut, demonstrating the therapy's potential for treating early Crohn's disease and prevention of relapse.
Johnson & Johnson's Janssen Pharmaceuticals Inc. unit, which initially developed PRV-6527, has 90 days to exercise its option to reacquire and further develop the drug for inflammatory bowel disease.
Provention and Janssen have a licensing agreement in which Janssen has the right to buy back PRV-6527 for a $50 million one-time payment and single-digit royalties on future net sales. If Janssen decides not to repurchase PRV-6527, Provention could sublicense the asset globally to another partner.