NASH new drug has made significant progress, ending phase 2 clinically

NASH new drug has made significant progress, ending phase 2 clinically

April 03, 2018 Source: WuXi PharmaTech

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MediciNova Biopharmaceuticals announced today that MN-001 (tipelukast) is a nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease with hypertriglyceridemia (NAFLD) due to important positive results in the interim analysis. Phase 2 clinical trials were terminated early.

NASH is a severe nonalcoholic fatty liver disease characterized by accumulation of liver fat, accompanied by inflammation and cellular damage. Inflammation can lead to liver fibrosis, cirrhosis, portal hypertension, and liver cancer, and ultimately to liver failure. NASH is an emerging health crisis that affects 3% to 5% of the US population and 2% to 4% of the global population, which is responsible for the rapid growth of liver cancer and liver transplantation in the United States. The rise in the incidence of NASH is associated with obesity and is often found in patients with diagnosed diabetes, high cholesterol or high triglycerides. There are currently no approved therapies for NASH.

MN-001 (tipelukast) is a novel oral bioavailable small molecule compound that produces anti-inflammatory and anti-fibrotic activities in preclinical models through several mechanisms, including leukotriene (LT) receptor antagonism, Phosphodiesterase (PDE) and 5-lipoxygenase (5-LO) inhibition. The inhibition of 5-LO by MN-001 and the 5-LO/LT pathway are considered to be new approaches to the treatment of fibrosis. MN-001 can down-regulate the expression of fibrogenic genes such as LOXL2, collagen type I and TIMP-1, as well as down-regulate the expression of genes that promote inflammation such as CCR2 and MCP-1. In addition, histopathological data show that MN-001 can reduce fibrosis in a variety of animal models.

This Phase 2a clinical trial is a multicenter, proof-of-concept, open-label study designed to evaluate the efficacy, safety, and tolerability of MN-001 in NASH or NAFLD patients with hypertriglyceridemia. Subjects were aged between 21 and 65 years with histologically confirmed NASH, or imaging confirmed to be NAFLD, and patients with serum triglycerides greater than 150 mg/dL at the screening stage. The detailed results of this interim analysis will be presented this month at the 53rd Annual International Liver Disease Conference of the European Association for the Study of Liver (EASL) in Paris, France.

Studies have shown that MN-001 can significantly reduce mean serum triglyceride levels from 260.1 mg/dL before treatment to 185.2 mg/dL after 8 weeks of treatment (p = 0.00006). There were no clinically significant safety or tolerability issues during the study. After achieving the most important research endpoint, MediciNova will stop patient recruitment and research to accelerate the development of MN-001.

â–² Dr. Yuichi Iwaki, President and CEO of MediciNova (Source: MediciNova Official Website)

Dr. Yuichi Iwaki, President and CEO of MediciNova, commented: "We are very excited about the results of this study, which shows a significant reduction in triglycerides. Based on this result and our clinical studies from other indications Triglyceride data, we believe that MN-001 has the potential to benefit a wide range of patients with hypertriglyceridemia, not limited to NASH and NAFLD patients."

We look forward to the success of this drug in the next clinical trials, bringing new treatments to this wide-ranging disease as soon as possible.

Reference materials:

[1] MediciNova Announces Phase 2 Trial of MN-001 (tipelukast) in NASH / NAFLD will be Terminated Early based on SignificantPositive Results from Interim Analysis

[2] MediciNova official website

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