DENMARK – Novo Nordisk has published topline results from six Phase 3a clinical trials in the ONWARDS program of once-weekly insulin icodec in diabetics.
Insulin icodec is a novel once-weekly basal insulin analogue that is designed to cover a full week’s worth of basal insulin requirements with a single subcutaneous injection.
Currently, the longest-lasting basal insulin products are injected once daily. Insulin icodec is currently undergoing phase 3 clinical trials.
Once-weekly insulin icodec was found to be non-inferior to once-daily basal insulin in lowering HbA1c in the ONWARDS 5 study. The primary endpoint was met at the conclusion of the 52-week open-label trial.
The news adds to ONWARDS trial readouts dating back to April. In July, the company announced headline results from the ONWARDS 3 and ONWARDS 4 Phase 3a trials with once-weekly insulin icodec.
ONWARDS 4 looked at basal-bolus treatment in people with Type 2 diabetes, pitting insulin icodec against insulin glargine, sold by Sanofi as Lantus.
The once-weekly insulin icodec achieved a superior reduction in estimated HbA1 of -1.68% points from a baseline HbA1 of 8.9%, compared to -1.31% points for once-daily basal insulins.
Novo Nordisk’s ONWARDS program for once-weekly insulin icodec includes six global phase 3a clinical trials, including one with real-world data (RWD) involving over 4,000 adults with type 1 or type 2 diabetes.
The company’s Onwards program is now down to a single study, and Holst Lange, executive vice president for development at Novo says results are just around the corner.
Insulin icodec is an acylated insulin analog that binds strongly to albumin in the body while decreasing affinity for insulin receptors, resulting in the formation of an inactive reservoir that gradually releases active insulin over time.
The ONWARDS 5 trial had fewer visits than the previous ONWARDS phase 3a trials, and once-weekly insulin icodec appeared to be safe and well-tolerated.
With the completion of the icodec trials, Novo can move closer to the hoped-for approval. It plans to file regulatory documents in the United States, the European Union, and China in the first half of 2023.
“These results include real-world elements and a dosing guide app, which help us better understand how insulin icodec can make a difference for patients in a clinical practice setting,” Holst Lange said in an October 3 release.
“We now look forward to sharing the results with regulatory authorities.”
Novo acquired worldwide marketing rights to Zealand Pharma’s diabetes treatment Zegalogue earlier this month, as well as a US$1.1 billion buyout of Forma Therapeutics Holdings Inc for its sickle cell drug.
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