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Provention Bio's Phase 2a Study On Crohn's Disease Fails To Meet Primary Goal

Provention Bio Inc. (PRVB) reported that Phase 2a PRINCE Clinical Trial with PRV-6527 in patients with moderate to severe Crohn's disease did not achieve primary endpoint due to high placebo effect.

In the pre-market, PRVB is trading at $5.50, down $0.57 or 9.39 percent.

The company noted that PRV-6527 was found to be generally safe and well tolerated, with no drug-related serious adverse events.

As per licensing agreement with Provention, Janssen has the right to buy back PRV-6527 for a one-time payment of $50 million and single-digit royalties on future net sales. In the event that Janssen does not take back PRV-6527, Provention is free to sublicence the program on a worldwide basis to another partner in the field of inflammatory bowel disease.

Crohn's disease is a chronic, immune-mediated inflammatory bowel disease (IBD) characterized by inflammation of the gastrointestinal (GI) tract. Myeloid cells, a species of antigen-presenting cells, are believed to play a central role in Crohn's disease by presenting microbiome antigens to white blood cells in the gut.

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