Key takeaways:
- Reasons for endpoint failure included an unexpected high treatment effect in the vehicle arm and high discontinuation rates in active arms.
- VYNE Therapeutics plans to terminate its extension phase of the trial.
A phase 2b study evaluating repibresib gel in nonsegmental vitiligo did not meet its primary endpoint and an ongoing extension phase will now be discontinued, VYNE Therapeutics announced in a press release.
In the study, which included 177 participants with nonsegmental vitiligo, repibresib, a pan-bromodomain BET inhibitor, failed to improve key measures of vitiligo lesions,, defined as a proportion of participants treated with daily repibresib (VYN201) 1%, 2% or 3% gel achieving a Facial Vitiligo Area Scoring Index (F-VASI) of at least 50% from baseline at week 24 vs. vehicle. The study also missed a key secondary endpoint of F-VASI of at least 75%.
A phase 2b study evaluating repibresib gel in nonsegmental vitiligo did not meet its primary endpoint.
“We are disappointed with the results of our phase 2b trial, which were impacted by an unexpectedly high treatment effect in the vehicle arm and a high discontinuation rate in the active arms,” David Domzalski, president and CEO of VYNE, said in the release. “Although we missed our F-VASI50 and F-VASI75 endpoints, we did see a meaningful reduction in the percent change from baseline in both F-VASI and [Total]-VASI for our highest dose and are conducting a thorough evaluation of the full dataset to analyze any other data that may inform the results and our strategic next steps.”
Results showed F-VASI50 was achieved by 16.3% to 19.5% of participants in the repibresib arms, whereas the same outcome was achieved by 23.4% in the vehicle arm. Furthermore, 26.1%, 30.2% and 36.6% of participants in the repibresib 1%, 2% and 3% groups, respectively, dropped out of the study vs. 10.6% in the vehicle group.
According to the release, the company plans to terminate its extension phase of the trial and seek an external partner to continue developing repibresib.
“We will provide an update on our plans … in the coming weeks,” Domzalski said in the release.
