Kenny Shannon's questions to Corbus Pharmaceuticals Holdings (CRBP) leadership • Q3 2020
Question
Kenny Shannon from Jeffries, on behalf of Murray Recross, asked about the systemic sclerosis trial, questioning how the post-hoc analysis on patients with over two years of background therapy could be incorporated into a potential FDA label and whether new trials would be required. He also inquired about community feedback on a path forward for the cystic fibrosis program and whether the dermatomyositis trial was shortened due to competitor data or an efficacy read-through from other trials.
Answer
Barbara White, Chief Medical Officer and Head of Research, clarified that the recently completed Phase 3 systemic sclerosis study is not adequate for regulatory approval as it missed its primary endpoint, and a new Phase 3 study would be necessary. Similarly, for cystic fibrosis, she noted that failing the primary endpoint likely precludes that trial from being used for approval. Dr. White confirmed the decision to shorten the dermatomyositis trial was driven by the evolving competitive landscape, where competitor trials have shorter durations, rather than any read-through from the SSc or CF studies.