A Phase 2a clinical trial, PRINCE, evaluating Provention Bio’s (NASDAQ:PRVB) PRV-6527,
a small molecule oral inhibitor of CSF-1R in-licensed from Janssen
Pharmaceutical Company, in 93 patients with moderate-to-severe Crohn’s
disease who were either naïve to biologic therapy or failed to
adequately respond to at least one prior biologic drug showed a
treatment effect but did not sufficiently separate from placebo.
Specifically, the study failed to achieve the
primary endpoint of a statistically significant change in a scale called
CDAI at week 12 compared to control due to a higher-than-expected
placebo response possibly related to the background medication used in
~85% of the participants.
On the positive side, PRV-6527 was safe and well-tolerated.
Under the terms of the license agreement, Janssen
has 90 days to exercise its option to re-acquire the candidate for $50M
and single-digit royalties on net sales. If it declines to do so,
Provention may sublicense the program on a global basis.
The company will host a conference call momentarily to discuss the results.
https://seekingalpha.com/news/3507702-provention-bio-9-percent-premarket-prvminus-6527-flop
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