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Galmed To Design Phase III NASH Trial With FDA After Strong Aramchol Data

 
• By Sten Stovall

The Israel-based biopharma company said a Phase IIb trial of its oral treatment of non-alcoholic steatohepatitis hit the necessary endpoints to support a Phase III trial and FDA marketing application.

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Talks To Follow 'Positive Top-Line Data' From Phase IIb ARREST study • Source: Shutterstock

Galmed Pharmaceuticals Ltd. said it will soon enter talks with the US FDA on designing a Phase III trial of its liver-targeted SCD1 modulator Aramchol for treating non-alcoholic steatohepatitis (NASH) after positive Phase IIb top-line data showed it met the necessary endpoints.

The NASDAQ-listed Israeli company said the Phase IIb ARREST study of its lead drug candidate supported a pivotal trial and an FDA marketing application after the once-daily

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