Processa Pharmaceuticals announced that positive gastric emptying results from its PCS12852 Phase 2A Proof-of-Concept trial in patients with moderate to severe gastroparesis. PCS12852 is a novel, potent, and highly selective 5-hydroxytryptamine-4 (5-HT4) receptor agonist, originally developed by Yuhan Corporation in South Korea, and exclusively licensed to Processa Pharmaceuticals in August 2020 (https://bit.ly/30iKnMR). 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. Adverse events associated with this Phase 2A trial were mild to moderate with no clinically significant cardiovascular or serious adverse events. Evaluation of the effect of PCS12852 on gastroparesis symptoms is expected before the end of this year. Processa plans to initiate a Phase 2B trial in 2023.
Article from BioSpace: PCS12852 Improves Gastric Emptying in Gastroparesis Patients | BioSpace