Ionis Could Be A Factor In MASH With Positive Phase II Data

Ionis’s DGAT2 inhibitor showed potential to improve disease activity score and resolve metabolic-associated steatohepatitis in a Phase II study, but analysts point to fibrosis-reduction data as competitively intriguing.

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Ionis's Phase II data may put its MASH candidate in the thick of the R&D race • Source: Shutterstock

As the industry awaits the potential first approval of a metabolic-associated steatohepatitis (MASH) drug on 14 March, Ionis Pharmaceuticals, Inc. may have worked its way into the race to follow Madrigal Pharmaceuticals, Inc.’s THRβ agonist resmetirom into the market, unveiling top-line Phase II data on 13 March for its antisense DGAT2 inhibitor ION224 that met statistical significance for biopsy-demonstrated improvement in disease score along with a secondary endpoint of MASH resolution.

Key Takeaways
  • Ionis hits primary and secondary endpoints in a Phase II trial of its antisense candidate for MASH.

  • Although not powered to demonstrate statistical significance...

In the 51-week study, two doses of ION224 – 120mg and 90 mg, each dosed subcutaneously once a month – met the primary endpoint of at least a two-point reduction...

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