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A Phase 2 Clinical Trial of a Drug for Gastroparesis

Processa Pharmaceuticals, a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have an unmet medical need, recently announced that it has enrolled its first patient in the Phase 2A clinical trial of PCS12852 in patients with moderate to severe gastroparesis. Gastroparesis is a chronic gastric motility disorder in which the stomach does not empty food as quickly as it should, resulting in potentially serious forms of heartburn, nausea, vomiting, and bloating for millions of patients in the United States. As such gastroparesis is recognized to be a serious unmet medical need condition for which patients need alternative treatment options.

Currently, the only FDA-approved pharmaceutical treatment for gastroparesis is metoclopramide, a dopamine D2 receptor antagonist, which is approved only for diabetic gastroparesis, not for other subsets of gastroparesis. Additionally, it carries a black box warning, limiting use for this chronic disorder to less than 12 weeks due to potentially serious side effects.

PCS12852 is a novel, potent, and highly selective 5-hydroxytryptamine-4 (5-HT4) receptor agonist. Although 5-HT4 receptor agonists have been effective for the treatment of gastroparesis in the past, the nonselective binding to other 5HT receptors has resulted in serious side effects and lack of use in gastroparesis patients. PCS12852 differs from other 5HT4 agonists because it has greater potency and is a more selective 5-HT4 agonist with a binding affinity to the 5-HT4 receptor being 200 times the affinity for other 5-HT receptors. Furthermore, preclinical and clinical studies with PCS12852 have shown minimal side effects at the effective dose.

“We are very pleased to announce that we have randomized the first patient in our PCS12852 Phase 2A study for the treatment of patients with gastroparesis, " says Sian Bigora, PharmD, chief development officer at Processa Pharmaceuticals. “In our previous Phase 2A clinical study in constipation patients, the gastric emptying rate significantly improved while on PCS12852 with no safety concerns. We expect this study to show a similar effect on the gastric emptying rate as well as provide us with valuable data on the effect of PCS12852 on the symptoms associated with gastroparesis in both diabetic and idiopathic gastroparesis patients. Information from the study will then be used to further design our Phase 2B study.”

The study (NCT05270460) is titled “A Phase 2A, Placebo-Controlled, Randomized, Dose Response Study of the Safety, Pharmacokinetics, and Efficacy of PCS12852 on Gastric Emptying Rate Assessed by 13C Spirulina Gastric Emptying Breath Test [GEBT] in Patients With Moderate to Severe Gastroparesis” and will be conducted in approximately 24 patients in up to eight centers in the United States.

— Source: Processa Pharmaceuticals