Processa Pharmaceuticals (NASDAQ: PCSA), a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients with unmet medical needs, today announced that it has been cleared by the U.S. Food and Drug Administration (“FDA”) to proceed with a phase 2a clinical trial of PCS12852. The trial will study PCS12852 in the treatment of patients with moderate to severe gastroparesis, an unmet medical need condition for which patients need alternative, safer treatment options. “This decision by the FDA is an important milestone in the clinical development program for PCS12852,” said Dr. David Young, CEO and chairman of Processa. “We have clinical data demonstrating that PCS12852 improves the gastric emptying rate in patients with functional constipation. Our IND will allow us to demonstrate that PCS12852 also improves the gastric emptying in gastroparesis patients, a market estimated to be as much as $1.6 billion. We expect to ramp up our phase 2a gastroparesis trial over the next few months and have our first patient dosed in Q1-2022.”
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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: PCS6422 (metastatic colorectal cancer and breast cancer), PCS499 (ulcerative necrobiosis lipoidica) and PCS12852 (GI motility/gastroparesis). The members of the Processa development team have been involved with more than 30 drug approvals by 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.
NOTE TO INVESTORS: The latest news and updates relating to PCSA are available in the company’s newsroom at https://ibn.fm/PCSA
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