▎WuXiEdited by Kant Content Team

Novo Nordisk announced positive results for its investigational diabetes therapy IcoSema in the pivotal Phase 3 trial COMBINE 1 at this year's first-half investor meeting.The company is scheduled to submit the therapy's marketing application for treating Type 2 Diabetes (T2D) patients to the regulatory authorities in China, the United States, and the European Union in the second half of this year.

The COMBINE 1 trial, which has been announced this time, is an international Phase 3 trial designed to compare the blood glucose control effects of once-weekly IcoSema with once-weekly insulin Icodec in patients with type 2 diabetes.A total of 1291 patients were enrolled in the trial and randomly assigned to receive IcoSema orIcodec InsulinTreatment lasts for 52 weeks, followed by a 5-week follow-up period.

The analysis shows,The trial met its primary endpoint, with HbA1c levels in the IcoSema group decreasing by 1.6 percentage points from baseline at week 52, compared to a 0.9 percentage point reduction in the insulin icodec group.Point, the difference is statistically significant.As for the secondary endpoints,Patients in the IcoSema group lost 3.7 kilograms at 52 weeks, while those in the insulin icodec group gained 1.9 kilograms., The difference between the two groups was statistically significant.

▲COMBINE 1 Trial Design and Results (Source: Reference [1])

In addition,The probability of severe hypoglycemic events in the IcoSema group (0.14 events per patient per year) was also significantly lower than that in patients treated with insulin icodec (0.63 events per patient per year).。IcoSema Demonstrates Good Safety and Tolerability in Trials.

IcoSema has three late-stage studies for the development of type 2 diabetes. In addition to COMBINE 1, Novo Nordisk announced positive COMBINE 3 data earlier this year and stated in its first-quarter financial report that the COMBINE 2 trial had been successfully completed. The results of the COMBINE 3 Phase 3a clinical trial, announced in January this year, showed,In 679 patients with type 2 diabetes who had poor glycemic control on once-daily basal insulin, once-weekly IcoSema demonstrated non-inferiority in reducing HbA1c compared to once-daily insulin therapy.

▲Icodec Insulin Structure (Image Source: Reference [4])

IcoSema is a fixed-ratio combination of once-weekly insulin icodec and once-weekly semaglutide.Icodec insulin is a human insulin analog with three amino acid substitutions and an attached C20 eicosanedioic acid chain, allowing the molecule to reversibly bind to albumin, thereby extending its half-life to 196 hours (approximately 7 days). It reaches a steady state after 3-4 weekly injections. This therapy is designed for once-weekly subcutaneous injection.Icodec insulin has been approved in the EU, Canada, Australia, and Japan under the trade name Awiqli.Semaglutide is a glucagon-like peptide-1 (GLP-1) analog, which, through breakthrough optimization of the peptide chain structure, extends the molecular half-life to 7 days, allowing for once-weekly dosing with very stable blood drug concentration.

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References:

[1] Novo Nordisk – a focused healthcare company. Retrieved August 12, 2024 from https://cdn.ipaper.io/iPaper/Files/d486663f-a195-49e2-b8ee-443a0d235bc6.pdf?Policy=eyJTdGF0ZW1lbnQiOlt7IlJlc291cmNlIjoiaHR0cHM6Ly9jZG4uaXBhcGVyLmlvL2lQYXBlci9GaWxlcy8qIiwiQ29uZGl0aW9uIjp7IkRhdGVMZXNzVGhhbiI6eyJBV1M6RXBvY2hUaW1lIjoxNzU0OTg2OTIxfX19XX0_&Signature=M6V4924Oo3vrU6mzHvAKurhKN0yttg4LvpOBJNUOlHit4jsH3XY-f0cnlPktIKS9WFDJnJYZ8N3WnH5bDeZvpd2eU~5PQOraACYcd7ZmivuQDEaYUyPRWzQdpRZqra5qqUrqh1~jUS6zxTkXkoQArA7lxjV5oMggLDLFXV~FcxI_&Key-Pair-Id=APKAIPGQN6BDBMBZ2LCA

[2] Novo Nordisk gears up for FDA filing with late-phase insulin plus semaglutide data. Retrieved August 12, 2024 from https://endpts.com/novo-nordisk-gears-up-for-fda-filing-with-late-phase-insulin-plus-semaglutide-data/

[3] After icodec rejection, Novo Nordisk plots 2024 FDA filing for once-weekly insulin and semaglutide combo. Retrieved August 12, 2024 from

https://www.fiercepharma.com/pharma/after-icodec-rejection-novo-nordisk-plots-2024-fda-filing-once-weekly-insulin-and

[4] Bajaj HS, Goldenberg RM. Insulin Icodec Weekly: A Basal Insulin Analogue for Type 2 Diabetes. touchREV Endocrinol. 2023 May;19(1):4-6. doi: 10.17925/EE.2023.19.1.4. Epub 2023 Mar 16. PMID: 37313230; PMCID: PMC10258611.

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