Could small molecule drugs treat rare liver diseases?

Novel PPAR alpha/delta agonists ‘may offer important new therapeutic options for long-term treatment’ [of primary biliary cholangitis (PBC)].

Key data revealed positive topline data. Relative^® Elafibranol Phase III Trial, an investigational dual α,δ PPAR agonist for primary biliary cholangitis (PBC). The data showed that 51 percent of his patients who received the small molecule drug elafibranol 80 mg had a cholestatic response, compared to 4 percent of his patients who received a placebo.

The phase III trial enrolled 161 patients. A novel, oral, once-daily dual peroxisome-activated receptor (PPAR) in patients who have previously experienced an inadequate response or intolerance to the current standard of care, ursodeoxycholic acid (UDCA) ) evaluated alpha/delta (α, δ) agonists. .

The cholestatic response to small-molecule therapy is clinical trials Alkaline phosphatase (ALP) < 1.67 x upper limit of normal (ULN) with ≥15 percent reduction in ALP and total bilirubin (TB) ≤ ULN at week 52. ALP and bilirubin are important predictors of disease progression. Decreased levels of both may indicate a reduction in cholestasis disorders and improved liver function.

“[The small molecule treatment] It may provide an important new treatment option for long-term treatment of patients with this debilitating disease. ”

“These are encouraging results suggesting that elafibranol may be an effective treatment to prevent the progression of PBC in patients undergoing UDCA. It has the potential to provide an important new therapeutic option for the long-term treatment of patients with this debilitating disease,” said Howard Mayer, Executive Vice President and Head of Research and Development at Ipsen.

“We are pleased with these results as PBC remains a disease of great unmet medical need,” said Pascal Prigento, CEO of GENFIT.

A significant proportion of PBC patients are unable to benefit from existing treatments. In Europe, it is estimated that 22.27 patients per 100,000 have a rare autoimmune cholestatic liver disease. In this condition, the bile ducts of the liver are gradually destroyed. This damage can interfere with the liver’s ability to move toxins through the body. According to research highlighted by GENFIT and Ipsen, scarring of liver tissue (cirrhosis) can occur.

Affirmatively speaking, drug developmentMayer added that Ipsen plans to “go ahead with regulatory submissions to the US Food and Drug Administration and the European Medicines Agency.” [EMA]”

Full data from the ELATIVE study of small molecule therapeutics will be presented at a future scientific meeting.

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