Hanmi Pharmaceutical said Tuesday that the company would present its recent clinical study results at the International Liver Congress (ILC) organized by the European Association for the Study of the Liver.
The latest study results of LAPSTriple Agonist (HM15211) are a triple agent for non-alcoholic steatohepatitis (NASH), where the combination of fat, inflammation, and fibrosis affects the patient, were selected for the late-breaking session of the conference.
The U.S. Food and Drug Administration (FDA) has also designated Hanmi Pharmaceutical’s HM15211 as a fast track program.
The European association will host ILC online from Aug. 27-29 because of the Covid-19 pandemic. Hanmi will release three study results as the poster and oral presentations. At the session, Professor Manal Abdelmalek of Duke University School of Medicine will present the results of phase 2a clinical study on HM15211.
Hanmi confirmed safety, tolerability, and the reduction of the fatty liver through 12 weeks of repeated administration of HM15211 on 66 obese patients who participated in the study with non-alcoholic fatty liver disease.
The highest dosage group showed an average 81.2 percent decrease in liver fat, and every patient in the group experienced a reduction of at least 50 percent.
|The graph shows the relative reduction of liver fat in non-alcoholic fatty liver disease patients who received LAPSTriple Agonist (HM15211) therapy. (Hanmi Pharmaceutical)|
More than 70 percent of the lower dosage group showed the reducing effect of liver fat by more than 30 percent, proving the most excellent effect of decreasing liver fat among NASH treatments being developed globally, according to the company.
Hanmi will also introduce a poster of a global phase 1 study that confirmed the safety and tolerability of HM15211, which targets fat, inflammation, and fibrosis, in 41 obese but healthy patients.
“We believe that we will be able to develop several new bio drugs based on our Labscovery technology as the world’s best therapies for NASH, for which there have been few innovative treatments so far,” Hanmi Pharmaceutical CEO Kwon Se-chang said.
<© Korea Biomedical Review, All rights reserved.>