Novo Nordisk’s bid to bring an oral version of its new diabetes injectable Ozempic (semaglutide) to market has taken a step forward, with the release of its first late-stage trial results.
PIONEER 1, oral semaglutide’s first phase III study, investigated its safety and efficacy in in adults with type 2 diabetes who took 3, 7 and 14mg doses of the drug compared with placebo in 703 patients.
The trial achieved its primary objective by demonstrating significant and superior improvements in long-term blood sugar (HbA1c) for all three doses of semaglutide compared to placebo.
More specifically, participants treated with 3, 7 and 14mg of oral semaglutide achieved reductions in HbA1c of 0.8%, 1.3% and 1.5%, respectively, compared to those on placebo who saw a reduction of just 0.1%.
And like its injectable counterpart, the 14mg dose of the drug also demonstrated a weight-loss benefit over placebo, however this time it did not reach statistical significance.
Novo’s chief science officer Mads Krogsgaard Thomsen said Novo is “encouraged” by the results and that they “confirm the unprecedented oral efficacy of semaglutide that was reported in the phase II clinical trial in type 2 diabetes”.
He added: “We look forward to providing data from the remaining nine PIONEER trials throughout this year.”
If all goes well the company has its sights set on a 2019 regulatory filling. If approved it would further ramp up the pressure on Eli Lilly’s Trulicity (dulaglutide), which already received a sting last year following a head-to-head trial with Novo’s Ozempic.
That particular trial, SUSTAIN 7, saw Lilly’s blockbuster beaten by Novo’s GLP-1 antagonist, with reports of a greater reduction in HbA1c levels for patients taking Ozempic.