Processa Pharmaceuticals, Inc. announced it has received guidance from the U.S. Food and Drug Administration ("FDA") regarding the Company's next trial for Next Generation Chemotherapy-Capecitabine ("NGC-Cap"). The trial for NGC-Cap, the combination of PCS6422 and capecitabine, will be a Phase 2 safety-efficacy trial in colorectal cancer patients following the principles of FDA's Project Optimus Oncology Initiative, the recent FDA recommendation on how oncology drugs are to be developed going forward. The Phase 2 trial will be designed to determine the dose-and exposure-response relationships for both anti-tumor activity and safety/tolerability by evaluating different dosage regimens.

The final dosage regimens to be used in the Phase 2 trial will be defined following the determination of the maximum tolerated dose from the Company's ongoing Phase 1b trial and in collaboration with the FDA. To expedite the enrollment of the first patient, Processa has begun the upfront study preparation tasks, including protocol preparation for submission to the existing IND and clinical enrollment planning.