Drug Development

What’s up with all the buzz about Gilead’s PhIII NASH drug selonsertib?

Earlier Wednesday we could detect a distinct disturbance in the biotech force as some careful students of clinicaltrials.gov picked up on some major — and recently filed — changes in the timelines listed for a readout on Gilead’s $GILD closely-watched NASH drug selonsertib.

STELLAR 4, their Phase III study for compensated cirrhosis due to NASH, and STELLAR 3, on advanced NASH and bridging F3 fibrosis, had been given near-term planned completion dates that lined up with Gilead’s repeatedly confirmed plans to post the initial results in Q1 and Q2. But the January and March completion dates were radically adjusted, just days ago, to November, 2022 and February, 2023.

Eyebrows were quickly raised.

The timelines on this drug are crucial to the company’s narrative as CEO John Milligan and Chairman John Martin head for the exits, with Roche’s Daniel O’Day coming in to take the helm. And the data are due as Intercept lines up rival late-stage data of its own.

A spokesman for Gilead, though, says that the interim readouts are still on tap for the first half, as analysts are eagerly anticipating.

Here’s the statement I got from Gilead Wednesday afternoon, right after the closing bell:

STELLAR 3 and 4 are phase 3 randomized, double-blind, placebo-controlled trials investigating the safety and efficacy of Selonsertib in adults with nonalcoholic steatohepatitis (NASH) with F3 bridging fibrosis or F4 cirrhosis, respectively. The interim analyses of these trials at 48 weeks are expected to read out in the first half of 2019. The trial completion data at 240 weeks duration is expected to complete in November 2022 for the STELLAR 4 trial and February 2023 for the STELLAR 3 trial.

Clinical trials.gov was recently updated to reflect 240 weeks as the primary completion dates of both STELLAR trials.

Jefferies’ Michael Yee is on watch duty, noting a couple of weeks ago that these readouts pose a significant catalyst for the company’s stock.

Management remains confident and “optimistic” about Phase III selonsertib, though they acknowledge odds are stacked against them.

This is one of the most carefully tracked data releases of 2019. So we’ll be there on the watch with him.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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