March 24, 2023 02:40 PM EDT Updated 13 hours ago R&D Pharma
Katherine Lewin
News Reporter
Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.
In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.
Novo Nordisk’s oral semaglutide is currently approved as Rybelsus when taken in 3 mg, 7 mg and 14 mg doses. The FDA approved the label expansion for the 7 and 14 mg doses in January of this year as a first-line treatment for type 2 diabetes. That update came after its initial approval in 2019 when the drug hit the market as the first GLP-1 pill to enter the type 2 diabetes market. And it remains the only one.
The PIONEER PLUS study hit its primary endpoint with a “statistically significant and superior reduction” in HbA1c, or blood sugar, at week 52 with both the 25 mg and 50 mg doses. Patients taking 25 mg saw a reduction of 1.9 percentage points of blood sugar, while those taking 50 mg saw a reduction of 2.2 percentage points compared to 14 mg. Those taking 14 mg had a reduction of 1.5 percentage points.
GLP-1 drugs have become blockbusters not just for their ability to help control diabetes, but also for their weight loss effects. Novo’s WeGovy, an injectable version approved for weight loss, became a blockbuster almost overnight.
The higher oral dose of semaglutides also showed an impact on weight, Novo reported. People treated with the oral semaglutide at 25 mg and 50 mg experienced weight loss of 7 kg (15 pounds) and 9.2 kg (20 pounds), respectively, compared with a reduction of 4.5 kg (9.9 pounds) with the 14 mg dose.
The Novo press release doesn’t give the weight the people in trial before treatment. But the effect appears to be smaller than with Wegovy, which has shown that obese or overweight patients lost 15% of their weight, from a baseline of 105 kg, according to the drug’s FDA label.
Regulatory path
A representative for Novo told Endpoints News that results from a separate trial called OASIS 1 investigating the effects of oral semaglutide in 50 mg doses in obesity will be presented at the American Diabetes Association conference in June.
The most common adverse events were mild to moderate gastrointestinal problems, typically while patients were escalating their doses.
Martin Holst Lange
“The higher efficacy from 25 mg and 50 mg doses provides the option to progress to higher doses if additional glycemic control or weight loss are needed,” Martin Holst Lange, EVP for development at Novo Nordisk, said in a statement.
According to the company, the plan is to file for regulatory approval for the higher dose in both the US and EU this year, depending on “portfolio prioritisations and manufacturing capacity.”
Novo Nordisk has two other injectible semaglutide brands, Ozempic, approved to treat type 2 diabetes, and Wegovy, approved to treat obesity.
Eli Lilly and Pfizer have also thrown their hats into the ring to develop an oral GLP-1. In December 2022, Pfizer began Phase II trials in its partnership with Sosei Heptares to test its candidate on patients with either type 2 diabetes or obesity. In the trial, some patients with type 2 diabetes will also be randomized to a Rybelsus 14 mg dose.
Meanwhile, Eli Lilly’s GIP/GLP-1 drug Mounjaro, which won approval in 2022 for adults with type 2 diabetes, is in studies for obesity, with an FDA filing for that use expected this year.
AUTHOR
Katherine Lewin
Leave a Reply