Processa Pharmaceuticals (NASDAQ: PCSA), a diversified clinical-stage company developing products to improve survival and/or the quality of life for patients with unmet medical need conditions, today announced positive top-line results on the clinical symptoms associated with gastroparesis from a 4-week Phase 2A study of PCS12852. The randomized, dose-response study for the treatment of patients with gastroparesis is designed to evaluate the safety, efficacy and pharmacokinetics of two dosage regimens of PCS12852 versus placebo. “This Phase 2A gastroparesis study shows a trend toward an increase in the gastric emptying rate and clinically meaningful improvements in gastroparesis symptoms in patients receiving a 0.5 mg daily dose of PCS12852,” said Dr. Sian Bigora, chief development officer at Processa. “The reduction in clinical symptoms and the continued improvement in the total ANMS GCSI-DD score and multiple individual symptom scores were better for the PCS12852 0.5 mg daily dose group than placebo or the 0.1 mg group. These findings suggest that a longer treatment than 28 days may result in greater differences in the gastroparesis symptoms for the 0.5 mg PCS12852 daily dose group when compared to the placebo dose group. These results, consistent with the previous pre-clinical and clinical studies, give us confidence that dosing 0.5 mg of PCS12852 daily for at least 12 weeks should improve the clinical symptom score more than a placebo treatment.”
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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 these criteria for selection to further develop its pipeline programs to achieve high-value milestones effectively and efficiently. Active clinical pipeline programs include Next Generation Capecitabine PCS6422 (metastatic colorectal cancer and breast cancer), PCS499 (ulcerative necrobiosis lipoidica) and PCS12852 (GI motility/gastroparesis). For more information, visit the company’s website at www.ProcessaPharma.com.
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