Hanmi Pharm's Innovative MASH Treatment Receives 'Sustainable Development Recommendation' From IDMC
Hanmi Pharm's Innovative MASH Treatment Receives 'Sustainable Development Recommendation' From IDMC
  • BK Min, 김상록
  • 승인 2024.05.10 10:43
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Hanmi Pharmaceutical is pleased to announce that it has received a significant recommendation from the Independent Data Monitoring Committee (IDMC). The IDMC has advised us to 'continue without change in plan' the phase 2 clinical trial of 'Efocipegtrutide,' a promising candidate for treating Metabolic Abnormality Steatohepatitis (MASH). This recommendation underscores the potential of Efocipegtrutide and strongly envies our ongoing efforts.

This IDMC was held for the 6th time in April to discuss whether to continue the clinical trial based on interim data from the global phase 2 clinical trial of Efocipegtrutide, which is ongoing in Korea and the United States. Safety-related data according to drug administration in 144 patients were discussed.

Efocipegtrutide is a triple-action bio-new drug that simultaneously activates glucagon, which increases energy metabolism in the body; GLP-1, which helps suppress insulin secretion and appetite; and GIP receptor, which promotes insulin secretion and has anti-inflammatory effects.

In May of last year, Hanmi Pharmaceutical conducted an interim analysis with IDMC among the three doses of Efocipegtrutide (2, 4, and 6mg/week) to exclude doses that could be considered useless in terms of efficacy. The interim results confirmed that no dose groups met the futility criteria, and development continued with the recommendation to proceed with the clinical trial to the end without excluding specific dose groups.

IDMC is an expert group that independently monitors patient safety and drug efficacy in advanced clinical trials. It operates to secure safety and scientific validity in clinical trials conducted in a randomized and double-blind manner. Additionally, as an independent committee with objectivity, it recommends to the clinical entity whether to continue the clinical trial, postpone patient recruitment, modify the clinical design, or discontinue it.

At Hanmi Pharmaceutical, we are committed to the continued research and development of Efocipegtrutide. The IDMC's recommendation for continued development is a testament to our dedication and the potential of this drug. We will redouble our efforts to complete drug development, guided by the objective indicator of the IDMC's recommendation.

Meanwhile, Hanmi Pharmaceutical is developing Efocipegtrutide and Efinopegdutide, licensed out to MSD in the U.S. for 1 trillion won in August 2020, as an innovative new drug for MASH treatment. In June last year, a global phase 2b trial was launched led by MSD in the United States.

The link to the Korean version of this article is as below.

▷한미약품 혁신 MASH 치료제, IDMC '지속개발 권고' 받아

Source_ⓒHanmi Pharmaceutical


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