Yuhan Yanghang "YH12852 Clinical Data Secured for Gastric Emptying Improvement in Gastroparesis Patients"

Technology Transfer to US Processa Pharmaceuticals
Positive Phase 2a Clinical Results... Phase 2b to Begin Next Year

Exterior view of Yuhan Corporation headquarters. [Photo by Yuhan Corporation]

[Asia Economy Reporter Lee Gwan-joo] Yuhan Corporation announced on the 10th that the new drug candidate 'YH12852 (PCS12852)', licensed to the U.S. company Processa Pharmaceuticals, has secured positive results in a Phase 2a clinical trial targeting patients with gastroparesis.

This clinical trial was conducted over 4 weeks with two different doses using a double-blind, placebo-controlled, randomized design to evaluate the safety, pharmacokinetic characteristics, gastric emptying rate, and efficacy on gastroparesis symptoms of YH12852 in patients with moderate to severe gastroparesis.

YH12852 is an agonist developed independently by Yuhan Corporation that shows excellent selectivity for the '5-hydroxytryptamine 4 (5-HT4)' receptor. It completed preclinical toxicity studies and Phase 1 clinical trials domestically before being licensed to Processa.

Existing 5-HT4 agonists used to treat gastrointestinal motility disorders have limitations due to low selectivity, binding to other receptors and causing serious cardiovascular adverse reactions. Other gastroparesis treatments that are not 5-HT4 agonists have black box warnings or usage restrictions due to side effects.

In contrast, YH12852 demonstrated improvement in gastrointestinal function without cardiovascular adverse reactions or serious side effects in healthy subjects and patients with constipation. All adverse reactions observed in this Phase 2a trial were mild to moderate, occurred within a few days after administration, resolved quickly without any lasting sequelae. No clinically significant, unexpected, or serious clinical reactions were observed during this trial.

Processa plans to initiate a Phase 2b clinical trial next year. Cyan Vigora, Chief Development Officer (CDO) of Processa, said, "We are pleased to confirm the prokinetic effect of YH12852 in patients with gastroparesis through this Phase 2a trial and to improve gastric emptying function." He added, "Gastroparesis remains an unmet medical need with no effective treatments, and we expect YH12852 to improve the lives of patients with gastroparesis going forward."

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