(Seoul, May 15, 2023) Independent Data Monitoring Committee (IDMC) recommends the global phase 2 clinical trial of LAPSTriple Agonist, a first-in-class drug for non-alcoholic steatohepatitis (NASH) treatment, which is being developed independently by Hanmi Pharmaceutical, to “continue without modification.”
IDMC's recommendation is a step forward from the past three recommendations based on the safety profile. It is also noteworthy because the recommendation was made based on the interim results that further evaluated the effectiveness of the ongoing global phase 2 trial.
In addition to the safety evaluation, the purpose of IDMC was to exclude a dose group that can be considered futile in terms of efficacy among the three currently undergoing clinical trials. However, the interim results confirmed that no dose group met the futility criterion, which led to carry out the clinical trial till the end without excluding a specific dose group.
An official from Hanmi Pharmaceutical said, “Detailed data cannot be confirmed as the clinical trial is being conducted with a double-blind design, but the IDMC recommendation suggests that the drug meets the expectations in terms of efficacy and safety.”
However, the company added that the results of this interim analysis do not guarantee final results and that no definitive conclusions can be reached until the final clinical trial results are announced.
IDMC is an expert group that independently monitors patient safety and drug efficacy in ongoing clinical trials. It operates to secure safety and scientific validity in clinical trials conducted in a random, double-blind way, etc. As an objective and independent committee, it recommends clinical subjects in terms of ‘continuation of clinical trials’, ‘postponement of patient recruitment’, ‘modification of the clinical design’, and ‘suspension of clinical trials.’
LAPSTriple Agonist is a triple action first-in-class innovative biologic drug that simultaneously activates Glucagon, which increases energy metabolism in the body; GLP-1, which helps insulin secretion and suppresses appetite; and GIP receptor, which promotes insulin secretion and has anti-inflammatory action.
On July 2020, the Food and Drug Administration(FDA) designated LAPSTriple Agonist as a Fast Track development drug for the treatment of NASH and as an orphan drug for the treatment of PBC(primary biliary cholangitis), PSC(primary sclerosing cholangitis), and IPF(idiopathic pulmonary fibrosis).
Hanmi Pharmaceutical is conducting a phase 2 clinical trial in the US and South Korea to confirm treatment efficacy, safety, and tolerability compared to placebo for NASH patients whose disease was confirmed by liver biopsy and followed by fibrosis.
An official from Hanmi Pharm said, “through this interim analysis result and IDMC recommendation, we were able to confirm the drug's efficacy and safety, as well as the potential for global new drug development”, also added that “this interim results will give patients hope for new treatments, and it will be a trigger for related hospitals and medical staff to pay more attention to the future research process.”
Meanwhile, Hanmi Pharmaceutical along with LAPSTriple Agonist, is also developing LAPSDual Agonist(efinopegdutide), which was licensed out to MSD in the US for 1 trillion won in August 2020 as a first-in-class drug for NASH treatment. Recently MSD has completed the global phase 2a, and the study results are expected to be announced next month(June) at EASL(The European Association for the Study of the Liver).
■ Contact info:
Official Websites : www.hanmipharm.com
innovation@hanmi.co.kr, +82-2-410-0467