Novo Nordisk trumpets NASH data with semaglutide

GLP-1 agonist semaglutide is already driving sales growth at Novo Nordisk from its use in diabetes, and now looks like it could add non-alcoholic steatohepatitis (NASH) to its tally.

The Danish drugmaker reported the results of a phase 2 trial of its subcutaneous formulation of semaglutide in NASH during its first-quarter results presentation, with the data suggesting it could succeed where many other drugs have failed.

The 72-week trial compared a daily injection with semaglutide to placebo in 320 patients, looking at resolution of NASH with no worsening of liver fibrosis. Data from 230 patients from an April analysis showed that the primary endpoint was met for all of the three doses of semaglutide tested (0.1, 0.2 and 0.4 mg) compared to control.

At the highest dose tested, 33 of 56 patients (59%) had NASH resolution, compared to 10 of 58 patients (17%) on placebo, and the safety profile was as expected from the GLP-1 agonists clinical trials in diabetes and obesity.

There were also positive trends on the secondary endpoint of liver fibrosis, although that didn’t reach statistical significance, and a significant reduction in fibrosis progression.

Semaglutide is sold in a once-weekly subcutaneous formulation called Ozempic and as a once-daily oral formulation as Rybelsus – both for diabetes – and has also shown promise in clinical trials as a treatment for obesity.

Sales of Ozempic rocketed by 234% in the first quarter to DKK 4.8bn ($689m), chasing down Eli Lilly’s market-leading rival Trulicity (dulaglutide) and elevating the drug to Novo’s second-largest product.

Rybelsus added another DKK 229m in the quarter, after getting FDA approval last September and a green light in the EU last month, and overall Novo Nordisk sales advanced by 16% to DKK 33.88bn.

If further trials back up its efficacy in NASH – and Novo looks set to push it into phase 3 quickly – it could unlock another big market for the company’s star drug.

According to GlobalData, the global market for NASH could be worth up to $25bn over the next few years, but there have been a lot of late-stage failures, notably Gilead’s selonsertib, Novartis/Conatus’ emricasan and Cymabay’s seladelpar.

In March, Zydus Cadila became the first pharma company in the world to win approval for a NASH drug, getting a green light in India for saroglitazar, another drug whose primary use has been to treat diabetes.

Another potential treatment for NASH – obeticholic acid from Intercept – is currently under review at the FDA, but the deadline for the regulator to deliver its verdict was recently pushed back from March to 26 June.

Following this is Genfit, whose phase 3 readout for its candidate elafibranor was delayed earlier this year, and there is a legion of other biopharmas behind it hoping to serve the largely still untapped market.