Business
Processa Pharmaceuticals Announces PCS12852 Successfully Improves the Clinical Symptoms Associated with Gastroparesis in Phase 2A Trial
A 0.5 mg daily dose of PCS12852 administered over 28 days in gastroparesis patients successfully improved gastroparesis symptoms in a clinically meaningful
About this update from Processa Pharmaceuticals, Inc.
[{"type":"text","content":"A 0.5 mg daily dose of PCS12852 administered over 28 days in gastroparesis patients successfully improved gastroparesis symptoms in a clinically meaningful way as defined by greater than a 0.5 reduction in the ANMS GCSI-DD score compared to baseline.The percentage of patients who met the clinically meaningful change in symptom score was greater in the PCS12852 0.5 mg daily dose group than in the placebo or the PCS12852 0.1 mg daily dose groups.Over 28 days the mean gastroparesis symptoms score continually improved more for the 0.5 mg PCS12852 group than the placebo group suggesting that longer treatment than 28 days may result in greater differences in gastroparesis symptoms for a 0.5 mg daily dose of PCS12852 than for placebo.The results, in addition to the previously announced improvements in gastric emptying in patients that received the daily dose of 0.5 mg of PCS12852, further support initiating a PCS12852 Phase 2B trial in 2023 for the treatment of gastroparesis. HANOVER, MD, Dec. 14, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a diversified clinical-stage company developing products to improve survival and/or the quality of life for patients who have an unmet medical need condition, today announced positive top-line results on the clinical symptoms associated with gastroparesis from a 4-week Phase 2A study of PCS12852, which is being developed for the treatment of patients with gastroparesis. The trial was a placebo-controlled, randomized, dose-response study designed to evaluate the safety, efficacy, and pharmacokinetics of two dosage regimens of PCS12852 vs placebo (clinicaltrials.gov identifier NCT05270460). Processa previously announced an improvement in the primary endpoint of the study, the gastric emptying rate, in patients that received a 0.5 mg daily dose of PCS12852. The results from this Phase 2A study also showed that clinically meaningful improvements in gastroparesis symptoms occurred in more patients (i.e., a greater percentage of patients) receiving the PCS12852 0.5 mg daily dose than the placebo daily dose. The study included 25 patients with moderate to severe gastroparesis that received a daily dose of PCS12852 (0.1 mg or 0.5 mg) or a placebo. Three patients dropped out of the study. Two patients were in the 0.5 mg group (one because of mild-moderate AEs and one did not provi...