UPDATE : Thursday, July 9, 2020
Hanmi gets FDA nod for nonalcoholic steatohepatitis treatment trials
  • By Lee Han-soo
  • Published 2018.04.19 15:29
  • Updated 2018.04.19 15:29
  • comments 0

Hanmi Pharmaceutical said Thursday that it has received approval to go ahead with the phase 1 trials for LAPSTriple Agonist(HM15211), a nonalcoholic steatohepatitis treatment.

With the approval, the company is confirming the efficacy and safety of the drug in 40 healthy adults with a body mass index (BMI) between 18 kg/m2 to 27 kg/m2.

HM15211 is biomedicine that utilizes Hanmi’s Lapscovery, a proprietary platform technology. The drug simultaneously activates GLP-1, which helps insulin secretion and appetite suppression, and GIP, which has insulin secretion and anti-inflammatory functions, to increase energy metabolism in the body.

The company is developing the drug into a once a week dosage form.

Hanmi has also confirmed the efficacy of HM15211 in improving fat and liver inflammation in animal models. The company believes that the drug will improve the quality of life of patients with the non-alcoholic fatty liver disease because there are no current therapeutic agents.

It is also conducting, along with Spectrum, a global phase-3 study on a long-acting neutropenia drug candidate called Rolontis (ingredient: Eflapegrastim).


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