Albireo’s Phase II LDL-C primary endpoint more pertinent in NASH versus Akcea/Ionis’ Phase IIb triglyceride reduction endpoint, experts say

24 Jul 2019

Albireo Pharma’s (NASDAQ:ALBO) Phase II elobixibat trial’s cardiovascular disease (CVD)-related primary endpoint may be more relevant to nonalcoholic steatohepatitis (NASH) than Akcea Therapeutics (NASDAQ:AKCA)/Ionis Pharmaceuticals’ (NASDAQ:IONS) Phase IIb trial’s CV outcome, experts said. Albireo’s trial has a low-density lipoprotein cholesterol (LDL-C) reduction endpoint whilst the AKCEA-ANGPTL3-LRx trial has an outcome of fasting triglyceride decrease.

LDL-C is manufactured in the liver and could block arteries, and so is relevant in both NASH and CVD, some experts said. As an ileal bile acid transporter (IBAT) inhibitor, elobixibat could mechanistically reduce LDL-C, as demonstrated in a Phase II dyslipidemia trial, others noted on the sidelines of July 2019’s Paris NASH Meeting.

However, IBAT inhibition still needs validation in NASH, considering an earlier therapy with the same mechanism has been discontinued, some noted. Diarrhea is a notable side effect, but should be expected due to elobixibat’s mechanism and is manageable, others said.

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