|Novo Nordisk Chief Science Officer Mads Krogsgaard Thomsen|
Novo Nordisk's ($NVO) new oral diabetes drug measured up to its injected counterpart in a midstage study, promising results the company heralds as a milestone in the field.
The drug, called OG217SC, is an oral version of Novo's semaglutide, now in Phase III development as a weekly subcutaneous treatment. Each acts as an analog of the hormone GLP-1 to promote the body's natural production of insulin, spurring weight loss and relieving the symptoms of Type 2 diabetes.
And the oral version did just that in Phase II, Novo said. In a 26-week, 600-patient trial designed to determine ideal doses for the drug, diabetics taking 40 mg of OG217SC--the highest dose--charted 1.9% reductions in blood A1C, which is a marker of glucose levels. By comparison, 1 mg of weekly injected semaglutide led to a 1.9% reduction, and placebo lowered A1C by .3%. Novo said the highest doses of the oral version also led to weight loss "comparable" with weekly semaglutide, which helped patients lose more than 14 pounds from a baseline of about 203.
And OG217SC was safe and well-tolerated, according to the company, with common side effects including nausea and vomiting that diminished over time. However, the worst adverse events came with the highest doses of the oral drug, Novo said, meaning 40 mg of OG217SC was harder to handle than 1 mg of subcutaneous semaglutide, despite their comparable efficacy.
Now Novo plans to discuss the results with global regulators, deciding whether to roll into Phase III with its oral treatment thereafter.
"We are very pleased with the results of this trial confirming the potential of semaglutide to treat Type 2 diabetes, both as a once-weekly subcutaneous injection and as a once-daily tablet," Novo Chief Science Officer Mads Krogsgaard Thomsen said in a statement. "This clinical proof of concept marks an important milestone for oral peptide therapy within the field of diabetes."
An oral option could radically change the blockbuster GLP-1 market, and Novo is working to fan out in the field and extend its dominance. The company's Victoza, a daily GLP-1 injection, leads the space with $2 billion in annual sales, and Novo won approval in 2014 for the obesity-treating Saxenda, a higher dose of the same active ingredient.
Meanwhile, Eli Lilly ($LLY) is fast encroaching on Novo's GLP-1 territory, securing FDA approval last year for the once-weekly Trulicity, the only contender that has measured up to Victoza in a Phase III trial.
- read the statement (PDF)