Processa Pharmaceuticals announced that they have been cleared by the FDA to proceed with a Phase 2a clinical trial of PCS12852 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). Non-clinical toxicology studies show that there are no cardiovascular side effects associated with PCS12852, making it a potentially safe treatment option for gastroparesis and other GI motility disorders. The Phase 2a study will be conducted in up to eight centers in the United States.
Article from GlobeNewsWire: https://www.globenewswire.com/news-release/2021/10/12/2312599/0/en/Processa-Pharmaceuticals-Cleared-by-FDA-to-Proceed-with-Phase-2a-Trial-for-the-Treatment-of-Gastroparesis.html