Processa Pharmaceuticals Inc (NASDAQ: PCSA) has enrolled one patient for its Phase IIa study of PCS12852. This therapy is for patients with gastroparesis, a chronic disease affecting gastric motility. With this disorder, the stomach fails to empty food contents as fast as required causing severe heartburn, bloating, vomiting, and nausea. The disease occurs with no gastric obstruction, especially pyloric stenosis.
Gastroparesis affects millions of people in the U.S alone. It also has limited treatment options making it an area with significant unmet needs. For this reason, the company set out to help patients with the disorder and help them improve their quality of life.
Drugs for gastroparesis have severe adverse effects
The U.S Food and Drug Administration previously approved metoclopramide to treat gastroparesis. However, the drug is only suitable for treating patients with diabetes who have gastroparesis. Moreover, it has severe side effects this can only be used for up to 12 weeks.
PCS12852, a 5-HT4 receptor, is highly selective. Scientists have used other compounds in this group to treat gastroparesis with high efficacy. However, the other compounds are non-selective 4-HT4 receptors. For this reason, they could bind to other 5-HT receptors resulting in adverse effects; thus, patients with gastroparesis cannot use it.
The drug is highly selective
PCS12852 is more selective than other 5-HT4 receptor agonists, and it only binds to 5-HT4 receptors making it safer. Furthermore, it has a higher binding affinity than other compounds and produces few adverse effects at appropriate doses.
According to Processa’s Chief Development Officer, Dr. Sian Bigora, the company is happy to have found its first patients for the Phase IIa trial as it tries to provide therapies for gastroparesis. The company had previously tested the drug on people with constipation. PCS12852 successfully improved gastric emptying and didn’t produce any significant side effects.
The company hopes to get the same results as it does the study on gastroparesis patients. In addition, Processa Pharmaceuticals hopes to determine how the compound affects the disease symptoms in patients with both idiopathic and diabetic gastroparesis. The company will conduct the Phase IIa trial on about 24 people in different U.S centers.
