Novo Nordisk rolled out its latest set of data for its next great hope: the oral version of semaglutide, which would become the only pill in the increasingly competitive GLP-1 class.
In trial No. 8 of a 10-trial program, which tested oral semaglutide in longtime diabetes patients, the drug beat placebo at reducing blood sugar and helping patients lose weight. The data add to Novo’s case for an approval, with a filing expected next year.
The study results come as Novo is struggling with pricing pressure, particularly for its insulin products, and cutting costs to cope. It’s also busy launching its injectable semaglutide formula, Ozempic, a weekly follow-up to its daily blockbuster Victoza and head-to-head rival to Eli Lilly’s Trulicity.
In the Pioneer-8 study, Novo tested the oral GLP-1 in patients who’d been diagnosed with diabetes for an average of 15 years. All of the participants used insulin. All doses of the drug, combined with insulin, beat an insulin-placebo combination at cutting HbA1C, a standard measure of blood glucose. The drug combo also did a better job with weight reduction compared with insulin alone, the company said on Friday. The details of that analysis—which included patients who stopped treatment during the trial—weren’t reported.
Under a different statistical analysis that only included patients treated throughout the trial, all doses delivered decreases in HbA1C, a standard blood sugar measurement, compared with no movement in the placebo group. The highest dose produced a mean 1.4% reduction.
As for weight loss, patients in the semaglutide arm lost at least 1 kg at the mean, and those on the highest dose lost 4.3 kg. That’s compared with a 0.6-kg weight loss in the placebo arm.
On the safety side, the most common side effect in the GLP-1 class—nausea—cropped up in 11% to 24% of people treated with the drug, compared with 7% of those in the placebo group. Up to 14% of semaglutide patients dropped out of the study because of nausea, compared with 3% of placebo patients. Hypoglycemic episodes for the Novo drug came in on par with placebo.
The data buttress a broad platform Novo has already put up for the pill. In June, the company rolled out favorable results pitting semaglutide against fellow Novo GLP-1 drug Victoza and Merck mammoth Januvia, a DPP-4 therapy, and in August, it put out a positive trial in patients whose kidneys are impaired.
The company will need all that clinical evidence as it pushes its pill into the tough GLP-1 market, which features stiff competition from Eli Lilly in addition to Novo’s own options. Further down the road, Novo’s GLP-1s could face another Eli Lilly competitor that recently put up impressive data of its own, including weight loss numbers in the double digits for the highest dose.
Analysts weren’t too fussed about those trial results, however; the drug is a long way off—with a launch perhaps in 2023—giving Novo time to put its next-gen offerings way ahead. Plus, the impressive weight loss stats came with nausea for 40% of patients. As Evercore ISI analyst Josh Schimmer noted in a missive to investors, the Lilly drug delivered its efficacy stats "at the expense of GI symptoms including nausea and vomiting; … go figure how those help control appetite/metabolic disease."
Meanwhile, the range of Pioneer results will also come into play when Novo sets a price. Novo has to “make some technical considerations” around pricing, CEO Lars Fruergaard Jørgensen said in a recent interview with FiercePharma, adding, “Do we price as a GLP-1, or do we price more as a tablet, or somewhere in between?”