Processa Pharmaceuticals (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 results from its PCS12852 Phase 2A trial in patients with moderate to severe gastroparesis. The four-week placebo-controlled, randomized, dose-response trial was designed to evaluate the effect of PCS12852 on gastric emptying, safety, pharmacokinetics, and gastroparesis symptoms. “We are pleased that this first Phase 2A study with PCS12852 was able to demonstrate a prokinetic effect and improve gastric emptying in gastroparesis patients,” said Dr. Sian Bigora, chief development officer at Processa. “The data from this study will inform the design of our planned Phase 2B study. Gastroparesis continues to be a serious disease that has unmet needs, and we are hopeful that PCS12852 will ultimately help improve the quality of life of gastroparesis patients.”
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About Processa Pharmaceuticals Inc.
The mission of Processa is to develop products with existing clinical evidence of efficacy for patients with unmet or underserved medical conditions who need treatment options that improve survival and/or quality of life. The company uses its Regulatory Science Approach criteria when selecting drugs for development in order to achieve high-value milestones effectively and efficiently. Active clinical pipeline programs include: PCS6422 (metastatic colorectal cancer, breast cancer), PCS12852 (gastroparesis, functional constipation), and PCS499 (ulcerative necrobiosis lipoidica). Members of the Processa development team have been involved with more than 30 approvals for indications in almost every division of the FDA (including drug products targeted to orphan disease conditions) and more than 100 FDA meetings throughout their careers. For more information, visit the company’s website at www.ProcessaPharma.com.
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