Drug Development

Gilead offers a glimpse at hard data to back up its $600M investment in Nimbus’ NASH drug

Gilead $GILD paid $600 million in fast cash to Nimbus to acquire rights to its early-stage NASH drug. And today it offered another reason why, while also demonstrating just how speedy this big biotech’s R&D squad can be when they feel like they’re on to something big.

Their drug, GS-0976, an inhibitor of Acetyl-CoA carboxylase, slashed levels of liver fat — the key culprit in NASH — by a median 43% in 10 patients in an open-label proof-of-concept study covering 12 weeks of therapy. There was a median decrease of 29 percent in hepatic DNL.

A biomarker of the disease — liver stiffness — dropped from 3.4 to 3.1 kPa at week 12, and investigators added some mouse data to help back up their case for this drug, which is already in a Phase II with 125 patients.

Eric J. Lawitz

Eric J. Lawitz, lead study author, concluded:

We know that elevated DNL is a major contributor to the pathogenesis of NASH and these data suggest that decreasing DNL through inhibition of ACC can lead to significant reductions in both liver fat content and stiffness, with early decreases in markers of liver fibrosis.

That’s all music to the ears of the team at Nimbus, which has another $600 million in milestones riding on this pact. It also helps Gilead, which has been castigated by a group of analysts for refusing so far to put its considerable cash cache to work acquiring a biotech or two that can significantly add to its late-stage pipeline.

NASH has become a big focus at Gilead, which is seeing its hep C fortunes wane as the first big wave of patients have been cured, in large part by its landmark drugs for the field.

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