Kenny Chan's questions to Corbus Pharmaceuticals Holdings (CRBP) leadership • Q3 2020
Question
Kenny Chan, on for Maury Raycroft, asked about the potential for the post-hoc findings from the systemic sclerosis trial to be incorporated into an FDA label and whether new trials would be required. He also inquired about feedback from the cystic fibrosis community and if the decision to shorten the dermatomyositis trial was influenced by competitor data or efficacy read-through from the other failed trials.
Answer
Chief Medical Officer and Head of Research, Barbara White, clarified that the completed Phase 3 systemic sclerosis study is not considered adequate for regulatory approval and that a new Phase 3 study would be necessary to move forward. Regarding cystic fibrosis, she stated that while conversations are ongoing, failing to meet a primary endpoint generally precludes a trial from being used as the basis for approval. Dr. White confirmed the decision to shorten the dermatomyositis trial was driven by an assessment of competitor trial durations, making it a strategic adjustment rather than a reaction to data from the SSc or CF studies.