Nimbus Therapeutics first made its name hustling a NASH drug from initial screening to the cusp of Phase I in 16 months. Now, it is proving equally adept at pulling in money at an eye-catching rate. Six months after Gilead ($GILD) paid Nimbus $400 million to buy the NASH drug, it has handed over another $200 million milestone payment.
The milestone payout means Nimbus has pocketed half of the potential $1.2 billion value of the deal within six months of it closing.
R&D progress has been similarly rapid. Since closing the deal in May, Gilead has initiated four clinical trials of the allosteric acetyl-CoA carboxylase (ACC) inhibitor. A trial to assess the pharmacodynamics of the ACC inhibitor, now known as GS-0976, in obese but otherwise healthy men has already come and gone. And Gilead is in the middle of another Phase I study to assess the pharmacokinetics of GS-0976 in adults with normal and impaired hepatic function.
The rest of the R&D program consists of a pair of Phase II trials.
One of the studies is comparing GS-0976 to placebo in a forecast 125 patients with NASH. The trial is primarily looking at the safety of GS-0976, but Gilead is also hoping to glean some insights into efficacy.
The other trial started out as an open-label assessment of Gilead’s apoptosis signal-regulating kinase 1 inhibitor GS-4997, but was expanded following the Nimbus deal to include GS-0976 and farnesoid X-activated receptor agonist GS-9674. Gilead acquired GS-9674 in the 2015 acquisition of Phenex Pharmaceuticals’ NASH program. Three cohorts of patients with non-alcoholic fatty liver disease (NAFLD) will each receive one of the drugs for 12 weeks. NASH in a severe form of NAFLD.
That 30-person study is indicative of the multi-front NASH drive now underway at Gilead. The Big Biotech delivered data from a mid-stage trial of GS-4997 in NASH last month, setting it up to move into Phase III study once it has wrapped up talks with regulators. While pushing forward with GS-4997, Gilead has pulled the plug on another of its NASH hopefuls, simtuzumab.
Gilead’s fast rollout of a clutch of trials featuring the drug it bought from Nimbus is keeping with the program’s development to date. The ACC inhibitor acted as a proving ground for the computational chemistry-enabled approach to drug design Nimbus created with Schrödinger. That method enabled the rapid advance of the NASH drug toward the clinic.