▎WuXiEdited by Kant Content Team
Today, Novo Nordisk (Novo NNovo Nordisk) held its Capital Markets Day 2024, reporting to the public on its latest R&D achievements and the company’s future operational strategies. During the event, the companyAnnounced the impressive trial results of its next-generation weight-loss therapy, Amycretin.WuXi AppTec's content team will combine official information with related media reports to introduce readers to Novo Nordisk's latest R&D progress and strategies.
Image Source: 123RF
Corporate Operating Strategy
According to the report by Novo Nordisk,The company will continue to focus on the development of diabetes and weight loss in the future.In addition to developing the next generation of insulin and GLP-1 therapies, Novo Nordisk will also focus on improving the quality of life for these patients and reducing their risk of death from related comorbidities. Beyond these two areas, Novo Nordisk will also concentrate on the development of therapies in the following different fields, including cardiovascular diseases, rare blood disorders, metabolic dysfunction-associated steatohepatitis (MASH), rare endocrine disorders, chronic kidney disease, as well as Alzheimer's and Parkinson's diseases.▲ Novo Nordisk focuses on the development in different therapeutic fields (Image source: official website of Novo Nordisk)
Novo Nordisk has also promoted its pipeline innovation and advancement in these different fields through cooperation and acquisitions with various companies in recent years.For example, its HS-001, a cell therapy under development in collaboration with Heartseed for the treatment of heart failure patients, has entered Phase 1/2 clinical trials in 2023. The in vivo gene-editing therapy for hemophilia A, developed in partnership with 2seventy bio, also achieved proof-of-concept last year.▲ Novo Nordisk Expands R&D Pipeline Through Collaboration and Acquisition (Image Source: Novo Nordisk's Official Website)
In addition, Novo Nordisk also expects to acquire Inversago Pharma after it reaches certain development and commercial milestones, a move that will encompass its weight-loss therapies, the oral CB1 receptor inverse agonists INV-202 and INV-347. Meanwhile, the small-molecule drug developed by Novo Nordisk in collaboration with Ventus Therapeutics for the treatment of atherosclerotic cardiovascular disease is also expected to enter Phase 1 clinical trials this year.▲Novo Nordisk actively integrates its siRNA platform into applications across different therapeutic areas(Image source: Novo Nordisk official website)
Notably, Novo Nordisk emphasized the progress in its siRNA platform development.Novo Nordisk began a research collaboration with RNAi therapeutics company Dicerna Pharmaceuticals in 2019 and proceeded with it in 2021.AcquisitionTo encapsulate its siRNA platform.By integrating siRNA technology into Novo Nordisk's existing technologies, the company is able to target intracellular targets across different disease areas, further enhancing its R&D capabilities.The company plans to initiate an average of one Phase 1 clinical trial related to siRNA therapy each year.Since 2017, 11 Phase 1 clinical trials have been initiated for siRNA treatments developed through its GalXC intracellular siRNA platform. Additionally, its RNAi therapy Rivfloza (nedosiran) was also approved last year.FDA ApprovalUsed to treat patients with Type 1 Primary Hyperoxaluria (PH1). In addition to targeting intrahepatic targets, siRNA therapies developed through Novo Nordisk's extrahepatic-targeting siRNA platform GalXC-Plus also initiated Phase 1 clinical trials in 2023.Advances in the Field of Weight Loss
Novo Nordisk also delivered a special report today on its development in the weight loss field. One of the most eye-catching updates was the latest clinical trial results of its oral GLP-1 and amylin long-acting co-agonist, amycretin.In this small Phase 1 trial involving 16 patients, those who received the treatment experienced a 13.1% reduction in body weight after 12 weeks, compared to only a 1.1% decrease in the placebo group.In addition, amycretin demonstrated favorable pharmacokinetic properties, as well as a safety profile, tolerability, and adverse event rates similar to those of existing GLP-1-based therapies. Furthermore, industry media outlet Fierce Biotech noted that results from the previous STEP-1 clinical trial showed that patients in the semaglutide group experienced a weight reduction of 14.9% over the 68-week trial period.Although the results between different clinical trials are difficult to compare directly,However, the rapid weight loss effect shown in the early results of amycretin's Phase 1 trial demonstrates the drug's significant potential.
▲Oral amycretin shows significant weight loss effect in Phase 1 trial(Image source: Novo Nordisk's official website)
In addition to amycretin, Novo Nordisk's CagriSema (a fixed-dose combination of semaglutide and the long-acting amylin analog cagrilintide) also showed positive results in a 20-week Phase 1 trial.CagriSema can lead to a weight loss of up to 17.1% in patients during the trial period, while the figure for the semaglutide group was only 9.8%.Currently, there are five Phase 3 clinical trials related to CagriSema ongoing.▲CagriSema Shows Positive Weight Loss Effects(Image Source: Novo Nordisk Official Website)
▲Five ongoing Phase 3 trials of CagriSema(Image source: Novo Nordisk's official website)
In addition, Novo NordiskDe's oral CB1 receptor inverse agonist INV-202 also showed positive results in Phase 1 clinical trials.After 28 days of treatment, patients in the INV-202 group experienced an average weight loss of 3.5 kilograms (3.3%), while patients in the placebo group gained 0.6 kilograms (0.5%), with a statistically significant difference between the two groups.The phase 2 trial for INV-202 in the treatment of obesity has been initiated, while the phase 1 trial for INV-347, the next-generation small molecule of INV-202, has also been launched.▲INV-202 Shows Positive Weight Loss Effects(Image source: Novo Nordisk's official website)
Advances in the Field of Diabetes
Currently, Novo Nordisk has several diabetes-related trials underway. In addition to testing the efficacy and safety of different doses and administration methods of semaglutide in diabetes patients, the company is also evaluating the effects of amycretin, INV-202, and its GIP/GLP-1 therapy NN9650 for treating diabetes and its related comorbidities. Novo Nordisk also has a DNA-based therapy in Phase 1 clinical development and three ongoing cell therapy research programs aimed at treating Type 1 diabetes.▲ Clinical Trials Related to Diabetes by Novo Nordisk(Image source: Novo Nordisk's official website)
▲ Clinical Trials Related to Diabetes by Novo Nordisk(Image source: Novo Nordisk's official website)
In a Phase 1 clinical trial examining its GIP/GLP-1 therapy,Compared with placebo, this therapy significantly reduced patients' glycated hemoglobin levels (HbA1c) by Week 4 and led to a nearly 12% decrease in body weight by Week 15.The therapy simultaneously demonstrated good safety, tolerability, and pharmacokinetic properties. Based on these results, Novo Nordisk expects to initiate related Phase 2 trials in patients with type 2 diabetes and obesity in the first half of 2024.▲ Positive Clinical Trial Results of Novo Nordisk's GIP/GLP-1 Therapy(Image source: Novo Nordisk official website)
In addition, the company also expects to initiate Phase 2 trials in the second half of 2024 to evaluate the efficacy and safety of oral and subcutaneous amycretin in patients with type 2 diabetes.▲Novo Nordisk to Conduct Phase 2 Clinical Trial of Amycretin in Diabetes Patients(Image source: Novo Nordisk official website)
With the announcement of these positive clinical trial results, as well as Novo NordiskNovo Nordisk continues to advance its diversified R&D pipeline, with expectations that the company will bring more innovative and effective therapies in the future, benefiting patient populations across various fields.
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ParticipateReferences:
[1] Highlights to be presented at Novo Nordisk’s Capital
Markets Day 2024. Retrieved March 7, 2024 from https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=167029
[2] Novo touts early data for next-gen oral weight loss drug
as it outlines next steps. Retrieved March 7, 2024 from https://endpts.com/novo-reports-early-weight-loss-data-for-amycretin-outlines-next-steps/
[3] Another day, another win for Novo in obesity, as early
oral med appears to beat Wegovy. Retrieved March 7, 2024 from https://www.fiercebiotech.com/biotech/another-day-another-win-novo-obesity-early-oral-med-beats-wegovy
[4] Heartseed and Novo Nordisk announce first patient dosed in clinical
study with HS-001 – a cell therapy designed to restore heart function in people
with advanced heart failure. Retrieved March 7, 2024 from https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=158901
[5] 2seventy bio and Novo Nordisk Collaboration Delivers Key Proof of
Concept Data, Triggering $15 Million Preclinical Milestone in In Vivo Gene
Editing Hemophilia A Program. Retrieved March 7, 2024 from https://ir.2seventybio.com/news-releases/news-release-details/2seventy-bio-and-novo-nordisk-collaboration-delivers-key-proof
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