Semaglutide Treatment for Peripheral Artery Disease Phase III Study Successful, IcoSema Submitted for Market Approval

On November 6, Novo Nordisk released its Q3 2024 financial report, disclosing several important updates:

1. The Phase IIIb STRIDE study of semaglutide 1.0mg for the treatment of Peripheral Artery Disease (PAD) has been successfully completed, and the company plans to apply for an expanded indication in the U.S. and EU in the first half of 2025.
2. The company has submitted a marketing application for IcoSema (Icodec insulin + semaglutide, once a week) for the treatment of type 2 diabetes (T2D) in the EU.
3. Based on the success of the Phase IIIb FRONTIER 5 study, Novo Nordisk expects to submit the first marketing application for Mim8 in 2025.

Details of the Studies

In September, Novo Nordisk successfully completed the 52-week Phase IIIb STRIDE study, which aimed to explore the functional outcomes of semaglutide versus placebo as an adjunctive therapy to standard care for patients with PAD and T2D. Lower limb PAD, caused by arteriosclerosis of the leg arteries, can lead to severe disability, and the risk of PAD is higher in T2D patients compared to non-T2D patients.

The study met its primary endpoint, showing that patients in the semaglutide group had a 13% significant improvement in maximal walking distance compared to the placebo group, with statistical significance and clinical relevance. The maximal walking distance for the semaglutide group increased by 21% (baseline: 185 meters), compared to 8% for the placebo group (baseline: 186 meters). Novo Nordisk expects to apply for an expanded indication for semaglutide in the U.S. and EU in the first half of 2025.

In October, Novo Nordisk submitted a marketing application to the EU for the combination product IcoSema (Icodec insulin + semaglutide, once a week) for the treatment of T2D.

Earlier, in January of this year, Novo Nordisk announced that the Phase IIIa COMBINE 3 study of IcoSema vs. basal insulin in the treatment of T2D had achieved its primary endpoint. With an overall baseline HbA1c of 8.30%, the IcoSema group showed an estimated HbA1c reduction of -1.47%, compared to -1.40% for the insulin glargine U100 and insulin aspart groups (estimated treatment difference: -0.06%).

In October, Novo Nordisk also successfully completed an open-label Phase IIIb FRONTIER 5 study, which included adult and adolescent patients with or without inhibitors suffering from hemophilia A.

This 26-week trial aimed to evaluate the safety of transitioning from Emicizumab prophylaxis to Mim8 prophylaxis. The results showed good tolerance when switching from Emicizumab to Mim8 treatment. Additionally, study participants were very fond of the Mim8 device and reported that the Mim8 pen injector was easy to use. After interacting with regulatory authorities, Novo Nordisk currently expects to submit the first approval application for Mim8 in 2025. 

It is worth mentioning that the Phase IIIa FRONTIER 2 study of Mim8 also had positive results in May this year. The study evaluated the efficacy and safety of weekly and monthly Mim8 prophylaxis in adolescent and adult patients with or without inhibitors. 

The results showed that in previously untreated hemophilia A patients, the weekly Mim8 group and monthly Mim8 group had a 97% and 99% reduction in treatment-related bleeds, respectively, compared to the group that had not received prophylaxis.