Processa Pharmaceuticals, the U.S. partner of Yuhan Corp., has released part of the U.S. phase 2a clinical trial result data of YH12852 (PCS12852), a candidate substance to treat gastrointestinal diseases.

Yuhan said Thursday that Processa has secured positive clinical results concerning improving gastric emptying in the YH12852’s phase 2a clinical trials on patients with moderate or severe gastric lethargy. The company conducted the phase 2a trial in a double-blind, placebo-controlled, and randomized method to evaluate YH12852’s safety, pharmacokinetic property, gastric emptying, and gastric lethargy for four weeks, using placebo or two different doses of YH12852.

YH12852 is a candidate substance to treat functional gastrointestinal disorders developed by Yuhan. The company conducted pre-clinical and phase 1 clinical trial in Korea before transferring the technology to Processa Pharmaceuticals in August 2020. Accordingly, the U.S. company possesses the right to develop, manufacture, and commercialize YH12852 worldwide, excluding Korea.

Yuhan expects YH12852 to demonstrate high safety contrary to the existing serotonin receptor agonists, 5-HT4, which showed cardiovascular abnormalities.

According to Yuhan, no clinically significant, unexpected, or serious clinical reactions were found in phase 2 clinical trials of YH12852. In addition, the company has judged that the candidate drug improved gastrointestinal function without cardiovascular or serious abnormalities in healthy patients and patients with constipation.

Yuhan added that abnormalities reported in 2a trials were mild to moderate, showing rapid improvement within days of administration without particular aftereffects.

"We are pleased to confirm that YH12852 facilitated stomach movement in people with gastric lethargy and improved gastric emptying effects through phase 2a clinical trials,” said Sian Bigora, Processa Pharmaceutical’s chief development officer.

CDO Bigora added that the clinical data would be useful in designing the scheduled phase 2 clinical trials.

“As gastric lethargy is a disease with unfulfilled demand with no effective treatment, we expect YH12852 to improve the lives of people with gastric lethargy,” he said.

Yuhan expects to receive milestones and royalties as Processa pushes ahead with YH12852’s clinical trials. The contract amount signed by Yuhan and Processa amounts to a maximum of $410.5 million. In addition, Yuhan has already received $2 million in down payment without obligation to return to Processa’s stocks.

In addition, Yuhan will receive milestones accompanying development and approval and a specific share of net sales as royalties after commercializing it. According to Yuhan, Processsa will finish securing useful data for 2a trials this year and begin 2b trials next year.