Processa Pharmaceuticals announces Phase 2 meeting with FDA

Processa Pharmaceuticals announces the outcomes from a successful meeting with the U.S. Food and Drug Administration regarding the Company’s next Phase 2 study supporting the advancement of Next Generation Capecitabine for cancer patients. “The FDA provided helpful guidance on the overall design of our NGC-Cap Phase 2 study for which we anticipate beginning enrollment in mid-2024. We believe that NGC-Cap may provide a better safety/efficacy profile than FDA-approved Capecitabine, eventually providing treatment for the tens of thousands of patients who cannot tolerate the existing Capecitabine,” said David Young, PharmD, Ph.D, President of Research and Development at Processa. “The results to date of our present Phase 1b oncology study clearly show that the metabolism and distribution of NGC-Cap is better than Capecitabine and that the safety/efficacy profile will likely be significantly better once we can identify the optimal dosage regimen.” The FDA provided guidance on the study design, the protocol, and the determination of the optimal dosage regimen using the principles of Project Optimus. The meeting with the FDA was supported by the interim results from the ongoing Phase 1b study that should complete enrollment in the first quarter of 2024. These interim results are expected to be available for public release by the end of the year.