Latest news with #REDEFINE2
Yahoo
3 days ago
- Business
- Yahoo
Novo Nordisk, Deep Apple Launch Drug Discovery Alliance For Weight Loss Oral Therapies
Deep Apple Therapeutics, Inc. announced on Wednesday a research collaboration and exclusive worldwide license agreement with Novo Nordisk A/S (NYSE:NVO) to discover, develop, and commercialize oral small molecule therapeutics directed at a novel non-incretin GPCR target for cardiometabolic diseases, including obesity. Under the terms of the agreement, Deep Apple will discover and optimize compounds using its proprietary drug discovery platform, which combines machine-learning-powered virtual screening with structural biology enabled by cryo-electron microscopy (cryo-EM) to dramatically improve speed, quality, and novelty in lead generation and optimization. Novo Nordisk will receive exclusive global rights to develop, manufacture, and commercialize the resulting compounds and products in all companies will collaborate on the research plan, with program handoff to Novo Nordisk occurring immediately before the start of IND-enabling studies. Deep Apple is eligible to receive an upfront payment, research costs, and milestone payments from Novo Nordisk. Deep Apple will be eligible to receive up to $812 million in payments and potential royalties on sales of any products that emerge from the collaboration. Recently, the Danish pharma giant initiated a Phase 3 trial to evaluate the efficacy and safety of cagrilintide sc combined with semaglutide sc (CagriSema sc) once weekly for weight management and long-term weight maintenance in obese participants. The two-part study in around 600 participants will last about 3 years and 3 months. In March, Novo Nordisk announced headline results from the REDEFINE 2 phase 3 trial in the global REDEFINE program. REDEFINE 2 is a 68-week efficacy and safety trial investigating once-weekly subcutaneous CagriSema compared to placebo. After 68 weeks, 61.9% of patients treated with CagriSema were on the highest dose. When evaluating treatment effects, if all people adhered to treatment, people treated with CagriSema achieved a weight loss of 15.7% after 68 weeks compared to 3.1% with placebo. Last week, Regeneron Pharmaceuticals, Inc.(NASDAQ:REGN) released interim results from the ongoing Phase 2 COURAGE trial evaluating Regeneron's trevogrumab (anti-GDF8/anti-myostatin) with semaglutide (GLP-1 receptor agonist) with or without garetosmab (anti-activin A) for obesity. The trial demonstrated that approximately 35% of semaglutide-induced weight loss was due to the loss of lean mass. Price Action: NVO stock is up 0.04% at $79.36 at the last check Wednesday. Read Next:Photo by JHVEPhoto via Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? NOVO NORDISK (NVO): Free Stock Analysis Report This article Novo Nordisk, Deep Apple Launch Drug Discovery Alliance For Weight Loss Oral Therapies originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
Reuters
10-03-2025
- Health
- Reuters
Novo Nordisk says trial with next-gen drug in diabetics shows 15.7% weight loss
COPENHAGEN, March 10 (Reuters) - Novo Nordisk ( opens new tab said on Monday its experimental next-generation drug CagriSema helped overweight or obese patients with type 2 diabetes cut their weight by 15.7% after 68 weeks. The data is seen as crucial for the future potential for its experimental next-generation obesity drug, after results published in December from another trial with the drug in people without diabetes showed lower-than-expected weight loss. The new data released on Monday from the phase III trial called REDEFINE 2 was based on about 1,200 people with type 2 diabetes and a body mass index (BMI) of or above 27 after 68 weeks. The REDEFINE 2 trial was based on a flexible protocol, allowing patients to modify their dosing throughout the trial, Novo Nordisk said in a statement. After 68 weeks, 61.9% of patients treated with CagriSema were on the highest dose, it added. If all people adhered to treatment with CagriSema, patients overall achieved weight loss of 15.7% after 68 weeks, compared to 31.1% with placebo. CagriSema is a weekly injection that combines semaglutide, which is the active ingredient in Wegovy and mimics the gut hormone GLP-1, and a separate molecule called cagrilintide that mimics the pancreatic hormone amylin, into a weekly injection. The two hormones combined suppress hunger and help control patients' blood glucose. here.
Yahoo
10-03-2025
- Health
- Yahoo
Novo Nordisk A/S: CagriSema demonstrates superior weight loss in adults with obesity or overweight and type 2 diabetes in the REDEFINE 2 trial
Bagsværd, Denmark, 10 March 2025 – Today, Novo Nordisk announced headline results from REDEFINE 2, a phase 3 trial in the global REDEFINE programme. REDEFINE 2 is a 68-week efficacy and safety trial investigating once-weekly subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to placebo. The trial included 1,206 randomised people with obesity or overweight and type 2 diabetes and a mean baseline body weight of 102 kg. The trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss at week 68 with CagriSema versus placebo. The REDEFINE 2 trial was based on a flexible protocol, allowing patients to modify their dosing throughout the trial. After 68 weeks, 61.9% of patients treated with CagriSema were on the highest dose. When evaluating the effects of treatment, if all people adhered to treatment1, people treated with CagriSema achieved a superior weight loss of 15.7% after 68 weeks compared to 3.1% with placebo. Weight loss of 5% or more after 68 weeks was a co-primary endpoint and was achieved by 89.7% of patients on CagriSema, compared to 30.3% by placebo. When applying the treatment policy estimand2, people treated with CagriSema achieved a superior weight loss of 13.7% compared to 3.4% with placebo. In the trial, CagriSema appeared to have a safe and well-tolerated profile. The most common adverse events with CagriSema were gastrointestinal, and the vast majority were mild to moderate and diminished over time, consistent with the GLP-1 receptor agonist class. 'The REDEFINE 2 results confirmed the superior efficacy of CagriSema in people with overweight or obesity and type 2 diabetes', said Martin Holst Lange, executive vice president for Development at Novo Nordisk. 'We look forward to bringing this second pivotal trial to regulatory authorities with the aim of making this next-generation therapy available to the millions of patients in need.' Novo Nordisk expects to file for the first regulatory approval of CagriSema in the first quarter of 2026. The detailed results from REDEFINE 1 and REDEFINE 2 will be presented at a scientific conference in 2025. About CagriSemaOnce-weekly subcutaneous CagriSema is being investigated by Novo Nordisk as a treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme). CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg. The two molecules induce weight loss by reducing hunger, increasing feelings of fullness and thereby helping people eat less and reduce their calorie intake. About the REDEFINE clinical trial programmeREDEFINE is a phase 3 clinical development programme with once-weekly subcutaneous CagriSema in obesity. The global clinical trial programme consists of two pivotal phase 3 trials, which have enrolled approximately 4,600 adults with overweight or obesity. The phase 3 trial programme includes: REDEFINE 1 – a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema, cagrilintide 2.4 mg and semaglutide 2.4 mg versus placebo in 3,417 adults with obesity or overweight with one or more comorbidities and without type 2 diabetes. REDEFINE 2 – a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema versus placebo in 1,200 adults with type 2 diabetes and either obesity or overweight. REDEFINE 3 – an event-driven cardiovascular outcomes phase 3 trial of once-weekly CagriSema versus placebo in 7,000 adults with established cardiovascular disease with or without type 2 diabetes. REDEFINE 4 – an 84-week efficacy and safety phase 3 trial of once-weekly CagriSema versus once-weekly tirzepatide 15 mg in 800 adults with obesity. About Novo NordiskNovo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 76,300 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289ambre@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode +45 3075 5956 jrde@ Sina Meyer +45 3079 6656 azey@ Ida Schaap Melvold +45 3077 5649idmg@ Max Ung +45 3077 6414 mxun@ Frederik Taylor Pitter +1 609 613 0568 fptr@ Company announcement No 11 / 20251 Based on the trial product estimand according to the trial protocol, regardless of dose strength2 Based on the treatment policy estimand: treatment effect regardless of treatment adherence Attachment CA250310-CagriSema-REDEFINE2Sign in to access your portfolio
