Processa Pharma announces positive results from PCS12852 phase 2A trial in patients with moderate to severe gastroparesis

Processa Pharmaceuticals, Inc., 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, announces positive gastric emptying results from its PCS12852 phase 2A trial in patients with moderate to severe gastroparesis. This phase 2A trial was a 4-week placebo-controlled, randomized, dose-response trial designed to evaluate the effect of PCS12852 on gastric emptying, safety, pharmacokinetics, and gastroparesis symptoms. Two dosage regimens of PCS12852 versus placebo were evaluated in patients with moderate to severe gastroparesis. PCS12852 is a novel, potent, and highly selective 5-hydroxytryptamine-4 (5-HT4) receptor agonist. While there are other 5-HT4 receptor agonists used to treat gastrointestinal (GI) motility disorders, these have less 5-HT4 selectivity and are associated with serious cardiovascular side effects due to the binding to other receptors. Although 2-5 million patients have moderate to severe chronic gastroparesis in the US, the only FDA-approved treatment options for gastroparesis have black box warnings and can only be used for 12 weeks due to adverse events. In contrast, PCS12852 has been shown in normal healthy volunteers and constipation patients to increase GI function with no cardiovascular and no serious adverse effects. Adverse events associated with this phase 2A trial were mild to moderate, occurring within the first few days after starting treatment, and quickly resolved without any sequelae. There were no clinically significant cardiovascular, unexpected, or serious adverse events (SAEs) reported during the study. Since the gastric emptying rate in gastroparesis patients is known to be delayed, the gastric emptying rate in the phase 2A study was assessed using the Cairn Diagnostic 13C Spirulina Gastric Emptying Breath Test (GEBT), which is an FDA-approved diagnostic tool used for measuring the rate of solid-phase gastric emptying and for identifying delayed gastric emptying. The gastric emptying rate half time (t50), as measured by the GEBT from baseline to Day 28, was calculated for each patient. GEBT results from this small Phase 2A Proof-of-Concept study, which included a total of 14 patients in the 0.5 mg (6 patients) and placebo (8 patients) groups, demonstrated statistical improvement in gastric emptying in patients receiving 0.5 mg of PCS12852 as compared to placebo at a p < 0.10 level. The mean (

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