Drugs

Provention Bio Crohn’s Trial Misses Endpoint

Provention Bio says its Phase 2 PRINCE clinical trial evaluating twice-daily Crohn’s disease drug PRV-6527, an oral Colony Stimulating Factor-1 Receptor (CSF-1R) small molecule inhibitor, showed that the therapy did not perform better that placebo. The study enrolled 93 moderate-to-severe Crohn’s disease patients who were either naïve to biologic therapy or who had previously failed at least one biologic drug. The primary efficacy endpoint of the study was the change in the Crohn's Disease Activity Index score at week 12.

“While PRV-6527 demonstrated a substantial improvement in this symptom driven score at week 12, it did not differentiate from placebo,” the company says. “This high placebo response is deemed to be related to the background medication used (about 85% of patients) in the study’s predominantly biologic-naïve population.”

PRV-6527 did show improvements in several key secondary objective endpoints in the steroid-free population, including mucosal endoscopy and tissue histology, according to the company. “Despite the PRINCE study’s high placebo effect, single dose level, limited 12-week duration, and relatively small sample size, the initial top-line results highlight how PRV-6527’s CSF-1R inhibition intercepts the migration of inflammatory cells to the gut. This rapid go/no-go, signal finding trial indicates a potential role for PRV-6527 as a well-tolerated, oral, first-line therapy in early Crohn's and, potentially, for the prevention of relapse.”

Under terms of a license agreement, Janssen now has 90 days to exercise its option to re-acquire the asset to support further development in inflammatory bowel disease, Provention Bio says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome