Yuhan Corporation Technology Export 'YH12852', First Patient Enrolled in Phase 2a Clinical Trial

[Asia Economy Reporter Lee Chun-hee] Yuhan Corporation announced on the 6th that the clinical Phase 2a trial of the new drug candidate ‘YH12852 (PCS12852)’, which was licensed out to Processa Pharmaceuticals, for patients with gastroparesis has completed the first patient enrollment and has officially begun.

Gastroparesis is a chronic gastric motility disorder characterized by delayed gastric emptying, causing severe heartburn, nausea, vomiting, and bloating. It can also lead to idiopathic diabetes and neurological disorders. The symptoms alone significantly impair patients' quality of life and daily activities, and it also lowers survival rates. Millions of patients in the United States suffer from this disease, creating a high unmet need for more effective treatments.

Currently, the only FDA-approved treatment for gastroparesis in the United States is metoclopramide, a dopamine D2 receptor antagonist. However, approval is limited to diabetic gastroparesis, and due to serious potential side effects, the duration of use is restricted to less than 12 weeks.

Previous serotonin receptor (5-HT4) agonists have been evaluated as effective, but they bind non-selectively to other 5-HT receptors, raising concerns about serious side effects. However, YH12852 is characterized by over 200 times higher binding affinity to the 5-HT4 receptor compared to other 5-HT receptors, demonstrating excellent selectivity and efficacy. Additionally, preclinical and clinical studies using YH12852 showed minimal side effects at effective doses.

This Phase 2a clinical trial aims to evaluate the safety, pharmacokinetic properties, and efficacy of YH12852 on gastric emptying rate assessed by the 13C-Spirulina gastric emptying breath test (GEBT) according to dosage in patients with moderate to severe gastroparesis. It is planned to be conducted at up to eight centers in the United States with a total of 24 patients.

Sean Vigora, Chief Development Officer (CDO) of Processa, stated, "During the use of YH12852 in patients with constipation, we confirmed a significant improvement in gastric emptying rate without major safety issues," adding, "We expect similar effects on gastric emptying rate in gastroparesis patients in this Phase 2a study." He further explained, "The results of this study will provide important data to confirm the efficacy of YH12852 on symptoms in patients with idiopathic and diabetic gastroparesis and will be useful in designing the subsequent Phase 2b trial."

This content was produced with the assistance of AI translation services.