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Processa Pharmaceuticals Announces Third Quarter Financial Results and Provides Corporate Update
PCS12852 successfully demonstrates a positive effect on the gastric emptying rate, clearing the path for a Phase 2B trial in 2023.Next Generation Capecitabine
About this update from Processa Pharmaceuticals, Inc.
[{"type":"text","content":"PCS12852 successfully demonstrates a positive effect on the gastric emptying rate, clearing the path for a Phase 2B trial in 2023.Next Generation Capecitabine (a combination of PCS6422 and capecitabine) successfully identifies dosing regimens for a Phase 2B trial to be initiated in 2023 after a meeting with FDA to discuss the alignment of the trial design with the FDA’s Project Optimus Oncology Initiative. HANOVER, Md., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (\"Processa\" or the \"Company\"), a diversified clinical-stage company developing drugs for patients who have unmet medical conditions and/or require better treatment options to improve a patient’s survival and/or quality of life, today announced financial results for the quarter ended September 30, 2022, and provided an update on its clinical programs. Dr. David Young, President and CEO of Processa, commented, “We are delighted to report our push to enroll patients in PCS12852 (Gastroparesis) and PCS6422 (Next Generation Capecitabine) has helped us get critical data and report successful preliminary results in both trials. The data from these trials will help us design Phase 2B trials for both programs. Next Generation Capecitabine (NGC) (a combination of PCS6422 and capecitabine): we have identified lower capecitabine dosage regimens when administered in NGC that will help avoid dose-limiting toxicities such as hand-foot syndrome, yet provide approximately 50-times greater potency than capecitabine alone. We will complete this study in the near future and seek FDA confirmation of our plans to implement the principles of the Project Optimus Oncology Initiative, wherein the objective is to optimize dosing to achieve a better balance between efficacy and safety than merely using the maximum tolerated dose.PCS12852: we have shown a statistical difference in the gastric emptying rate between the 6 patients on 0.5 mg of PCS12852 and the 8 patients on placebo at p-value All our energies have been directed towards the completion of these trials that inform the next steps for these much-needed therapies. Advancing these drugs in their respective clinical trial allows us to obtain the clinical data to better define each pivotal trial as well as provide us with more insight into how the FDA will review each of these products as we plan the ro...