Hanmi Pharm has received the green light to keep developing a new drug to treat non-alcoholic steatohepatitis (NASH).
On Monday, Hanmi said an Independent Data Monitoring Committee (IDMC) has recommended "continue without modification" for the ongoing global phase 2 clinical trials of its drug candidate, efocipegtrutide (development name HM15211).
The IDMC is a group of experts who monitor patient safety and drug efficacy in advanced-stage clinical trials. It operates to ensure the safety and scientific validity of clinical trials and makes recommendations to the trial conductor to continue the trial, postpone patient enrollment, modify the trial design, or discontinue the trial.
Previously, the IDMC had issued three “continued development recommendations” to Hanmi Pharm based on the safety profile.
The latest recommendation is significant because it is based on the results of an interim analysis that further evaluated efficacy.
The IDMC's recommendation allows Hanmi to proceed to the end of the trial without excluding certain dose groups.
According to the company, the interim results confirmed that no dose group was deemed ineffective.
Hanmi Pharm is conducting a phase 2 study in the U.S. and Korea to confirm the efficacy, safety, and tolerability of efocipegtrutide, compared to placebo, in patients whose liver biopsy confirmed NASH with fibrosis.
"Although detailed data cannot be confirmed as the clinical trial is being conducted in a double-blind design, the IDMC recommendation suggests that the drug is meeting expectations in terms of efficacy and safety," said a Hanmi Pharm official.
However, he added that the results of this interim analysis do not guarantee final results and no definitive conclusions can be drawn until the final clinical trial results are announced.
"The results of this interim analysis and the IDMC recommendation confirm the efficacy and safety of the drug and its potential for global drug development," said the official.
"The recommendation will give patients hope for a new treatment and more focus on future research for relevant organizations and physicians."
Efocipegtrutide is a “LAPSTriple Agonist,” which simultaneously activates glucagon, which increases energy metabolism in the body, GLP-1, which helps in insulin secretion and appetite suppression, and GIP receptor, which promotes insulin secretion and has anti-inflammatory effects.
In July 2022, the U.S. Food and Drug Administration (FDA) granted efocipegrutide fast track designation for the treatment of NASH. It also gave orphan drug designation for the treatment of primary biliary cholangitis (PCB) and primary sclerosing cholangitis (PSC), and idiopathic pulmonary fibrosis (IPF).
In addition, Hanmi Pharm is also involved in the development of efinopegdutide (development name HM12525A), a dual-acting NASH drug candidate that was in-licensed to Merck in the U.S. for 1 trillion won in August 2020.
The global phase 2a study, led by Merck, recently ended and the results of the study will be presented at the European Association for the Study of the Liver (EASL) in June.