Yuhan's gastric atony tx has completed the registration

of the first patient with phase 2A in the United States

Topline data will be derived at the end of 2022

Yuhan Corporation (CEO Cho Wook-je) announced on the 6th that it has completed the first patient registration in phase 2A of clinical trial for patients with gastric atony of the new drug candidate "YH12852 (PCS12852)" exported by Technology to Processa Pharmaceuticals.

 

Gastric atony is a chronic gastric motor disorder that causes severe heartburn, nausea, vomiting, and bloating due to delayed gastric emptying.

 

In the United States, millions of patients suffer from dysentery, and there is a high demand for more effective treatment development.

 

Currently, the only FDA-approved gastric atony treatment is Metoclopramide, a dopamine D2 receptor antagonist.

 

However, the drug has been approved only for diabatic gastric atony and has a limited duration of up to 12 weeks due to serious potential side effects.

 

Although past 5-HT4 agonists are effective, they bind non-selectively to other 5-HT receptors, resulting in serious side effects.

 

YH12852 developed by Yuhan shows more than 200 times higher binding power to 5-HT4 receptors than other 5-HT receptors and has excellent selectivity and efficacy.

 

Preclinical and clinical studies using YH12852 also showed minimal side effects in effective doses, so more clinical results are expected.

 

Dr.

 

Sian Bigora, head of development at Processa Pharmaceuticals, said, "We expect that this clinical 2A will have a similar effect on the gastric emptying rate of patients with gastric atony, as we confirmed that the gastrostomy rate was significantly improved while using YH12852 for constipation patients." He said, "The results of this study will provide important data to confirm the effect of YH12852 on the symptoms of patients with idiopathic and diabatic gastric atony, and will be useful for further designing clinical phase 2B." This clinical trial is a phase 2A clinical trial aimed at evaluating safety, pharmacokinetic properties, and efficacy of 13C-Spirulina Gastric Emptying Breath Test (GEBT) according to the dose of YH12852 in moderate or severe gastric atony patients, and will be conducted in a total of 24 patients in the U.S.