Just a week out from the European liver disease conference in Vienna, where you can expect much of the hype to be around nonalcoholic steatohepatitis drugs, fatty liver disease biotech NGM Biopharmaceuticals has got off a $107 million IPO, following in the footsteps of rival GenFit.
The biotech filed for a $75 million IPO last year but managed to get $32 million more in a market window that seems to just be staying open for biotech public offerings. The biotech will trade under the "NGM" ticker on the Nasdaq.
The cash boost will be put toward its midstage NASH hopeful NGM282, a nontumorigenic, engineered variant of the human hormone FGF19.
Two years back, at a liver disease conference, NGM Bio posted data showing it met its primary endpoint of reducing liver fat, as evidenced by the use of magnetic resonance imaging-estimated proton density fat fraction, with the 3-mg and 6-mg dose groups lowering absolute liver fat content by 9.7% and 11.9%, respectively, against a dummy treatment over 12 weeks.
Of the small batch of 53 patients (across both doses) treated with NGM282, 34% reached a normal liver fat content, with the greatest effect seen in those with the highest baseline liver fat content and most active disease. In all, 79% of patients in the study met its primary endpoint of a reduction of at least 5% in liver fat.
It also showed a hint of ability to improve scarring, although it also came with a spike in cholesterol levels, something also seen in some other NASH studies.
While these data were positive, NGM Bio is still behind front-runners Genfit, a French biotech which last month got off a $132 million IPO, and Intercept, with other drugs from Bristol-Myers Squibb, Gilead, Novartis and Allergan also in the mix. It still believes it can differentiate from some of its rivals and get in on a market some bullish expectations see as being worth $40 billion a year at peak.
It’s been a pretty good 2019 all round for NGM Bio: Merck doubled down on its R&D pact last month, and it’s nabbed a Genentech executive, Hsiao Lieu, M.D., as its new senior vice president and chief medical officer, poaching him from the Roche biologics unit where he was VP of early clinical development for its noncancer work.
The one downside was the Merck deal—while adding two more years to its research pact with the biotech, the Big Pharma also announced it was also culling work on an NGM obesity drug after it failed to make the grade in an early test last year.
The hit ticket, however, is still NASH for the biotech. NGM designed its leading drug to maintain the biological activity of FGF19, which modulates two receptors: FGFR4, a primary regulator of bile acid synthesis in the liver, and FGFR1c, a signaling receptor in metabolic processes in adipose tissue (peripheral fat) that regulates de novo lipogenesis, glucose homeostasis and body weight.
The biotech hopes NGM282’s activity on those receptors make it a powerful and direct modulator of multiple pathways that are key to the development and progression of NASH.The industry largely stopped work on FGF19 in the early 2000s, when animal studies of FGF19 identified the hormone drives tumor formation in rodents, but the biotech believes it has ironed out these issues as to avoid any repeats in human testing.
Other companies are taking a different approach to NASH targeting: Intercept’s obeticholic acid is an agonist of the farnesoid X receptor (FXR), which is a nuclear receptor. FXRs such as Ocaliva (there are many in development in the industry, including at Gilead, Novartis and Allergan) turn on as many as 100 different genes. Both Gilead and Intercept are presenting new and updated NASH data at Vienna next week.
Expect more midstage data out next year, with a phase 3 trial on the horizon should all go to plan.