Ionis Pharmaceuticals announced positive data from a Phase II clinical trial of ION224, an investigational DGAT2 antisense inhibitor for metabolic dysfunction-associated steatohepatitis (MASH).
This two-part, adaptive, multicenter, randomized, double-blind, placebo-controlled study evaluated the safety, efficacy, and pharmacokinetics of various doses of ION224 when administered subcutaneously once a month in adult patients with MASH. was analyzed.
160 subjects were enrolled who received either ION224 or placebo for 49 weeks.
The proportion of subjects who achieved histological improvement in MASH was the primary endpoint of the study.
According to the findings, the trial met its primary endpoint at both the 120mg and 90mg doses. We also achieved an important secondary endpoint: MASH resolution.
Of note, 44% of patients treated with 120 mg of ION224 achieved a relative reduction in hepatic steatosis of 50% or more, compared with 3% in the placebo group.
Access the most comprehensive company profiles on the market with GlobalData. Save research time. Increase competitiveness.
Company Profile – Free Sample
You will receive a download email shortly
We are confident in the unique quality of our company profile. However, we want you to make the decision that is most beneficial for your business, so we are offering free samples that you can download by submitting the form below.
by global data
ION224 showed statistically significant improvement in fibrosis stage without exacerbating steatohepatitis.
It was also found to be safe and well-tolerated, with no treatment-related serious adverse events or mortality reported during the study.
Sanjay Bhanot, Senior Vice President and Chief Medical Officer at Ionis, said: “Reducing the production of the DGAT2 enzyme reduces the overproduction of triglycerides, which causes excess liver fat that can lead to liver damage and inflammation.
“We showed that a monthly subcutaneous drug targeting DGAT2 may improve MASH and prevent progression to more severe stages such as progressive liver fibrosis and cirrhosis, I am encouraged by the ION224 data.
“Inhibition of DGAT2 offers a new approach to MASH, a progressive disease that requires better treatment options.”
Latest development comes after Phase III OASIS-HAE study of donidalorsen in patients with hereditary angioedema met primary endpoint; Ionis announces plans to file new drug application with U.S. Food and Drug Administration It was done after.
