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Processa Pharmaceuticals Provides Update on Enrollment Across all Clinical Programs
PCS12852 for Gastroparesis concluded enrollment a month ahead of schedule. Statistics on gastric emptying, safety and GEBT data will be available by the end
About this update from Processa Pharmaceuticals, Inc.
[{"type":"text","content":"PCS12852 for Gastroparesis concluded enrollment a month ahead of schedule. Statistics on gastric emptying, safety and GEBT data will be available by the end of October and full topline data is expected before year end.New site added for PCS6422 to accelerate enrollment, important data on de novo formation of DPD in October.New sites added and new geographic areas for PCS499.Efforts to create awareness of trials have had a positive effect on our enrollment across clinical programs. HANOVER, MD, Sept. 15, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), (“Processa” or “Company”), a clinical stage biopharmaceutical company focused on developing products to improve survival and/or quality of life for patients who have an unmet medical need condition for which there are few or no therapeutic options, today provided an update on enrollment across all its clinical programs. “Recruiting for studies of very rare diseases like ulcerative Necrobiosis Lipoidica can be challenging. We are encouraged by the results of our multi-faceted campaigns to increase the awareness and opportunities for patients to participate in our trial and are hopeful that these will continue to increase the number of patients in screening and enrollment. We have seen an increased willingness of patients to travel, potentially due to lower concerns about COVID” said Sian Bigora, Processa’s Chief Development Officer. “We are also very encouraged by the rapid enrollment in PCS12852. This reminds us of the extraordinarily limited treatment options for gastroparesis and that patients are looking for alternative options to treat this condition. We continue to advance our clinical programs and with the expectation of important data from these programs in late 2022, each program will move further in the clinical development towards NDA submissions”. PCS12852 The Company is pleased to announce completion of enrollment of our PCS12852 Phase 2A trial in moderate to severe gastroparesis ahead of its original expectations. This will allow it to release gastric emptying and efficacy/safety data and topline data by the end of 2022. This Phase 2A trial is a placebo-controlled, randomized, dose response study designed to evaluate the safety, pharmacokinetics and efficacy of PCS12852 on the gastric emptying rate as assessed by 13C Spirulina GEBT in patients wi...