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1月前
Veru Teams Up With Novo Nordisk for Obesity Combination Therapy Trial (VERU)June 4, 2026 10:22 AM
IH Market News Veru Inc. (NASDAQ:VERU) has entered into a clinical supply agreement with Novo Nordisk A/S (NYSE:NVO) to support its upcoming Phase 2b PLATEAU study, which will investigate a combination treatment for obesity in older adults. The agreement, signed on June 2, 2026, brings together Veru’s investigational therapy enobosarm and Novo Nordisk’s blockbuster weight-loss drug Wegovy. Phase 2b Study to Assess Combination Approach The PLATEAU clinical trial will evaluate the use of enobosarm alongside Wegovy (semaglutide injection) in older patients with obesity who are undergoing weight-loss treatment with Wegovy. Enobosarm is an oral selective androgen receptor modulator (SARM) that Veru is developing as part of its broader metabolic health and obesity strategy. The study is designed to examine the potential benefits of combining the two therapies in this patient population. Novo Nordisk to Supply Wegovy Under the terms of the agreement, Veru will serve as both sponsor and operator of the Phase 2b trial. Novo Nordisk will provide Wegovy for the study at no cost, supporting the clinical programme while allowing Veru to retain responsibility for trial execution and development activities. The arrangement gives Veru access to one of the leading GLP-1 obesity treatments while advancing its own clinical research efforts. Collaboration Includes Clinical Insights As part of the partnership, Veru will share knowledge and data related to obesity and weight-management studies with Novo Nordisk. This includes information regarding trial design, methodology and clinical execution, as well as regular updates covering study progress, protocol modifications and safety findings. The collaboration is intended to facilitate efficient study management while expanding understanding of combination approaches in obesity treatment. Veru Retains Global Rights to Enobosarm The company emphasized that it continues to hold full worldwide development and commercialization rights for enobosarm. However, the agreement grants Novo Nordisk a right of first negotiation should Veru seek to develop, commercialize or license intellectual property involving enobosarm in combination with any Novo Nordisk GLP-1 product for any therapeutic indication. The arrangement preserves Veru’s strategic flexibility while establishing a framework for potential future collaboration between the two companies in the growing obesity treatment market. Veru stock price Novo Nordisk stock price Original: Veru Teams Up With Novo Nordisk for Obesity Combination Therapy Trial (VERU)
iHub News
1月前
Veru Teams Up With Novo Nordisk for Obesity Combination Therapy Trial (HDRN)June 4, 2026 10:22 AM
IH Market News Veru Inc. (NASDAQ:VERU) has entered into a clinical supply agreement with Novo Nordisk A/S (NYSE:NVO) to support its upcoming Phase 2b PLATEAU study, which will investigate a combination treatment for obesity in older adults. The agreement, signed on June 2, 2026, brings together Veru’s investigational therapy enobosarm and Novo Nordisk’s blockbuster weight-loss drug Wegovy. Phase 2b Study to Assess Combination Approach The PLATEAU clinical trial will evaluate the use of enobosarm alongside Wegovy (semaglutide injection) in older patients with obesity who are undergoing weight-loss treatment with Wegovy. Enobosarm is an oral selective androgen receptor modulator (SARM) that Veru is developing as part of its broader metabolic health and obesity strategy. The study is designed to examine the potential benefits of combining the two therapies in this patient population. Novo Nordisk to Supply Wegovy Under the terms of the agreement, Veru will serve as both sponsor and operator of the Phase 2b trial. Novo Nordisk will provide Wegovy for the study at no cost, supporting the clinical programme while allowing Veru to retain responsibility for trial execution and development activities. The arrangement gives Veru access to one of the leading GLP-1 obesity treatments while advancing its own clinical research efforts. Collaboration Includes Clinical Insights As part of the partnership, Veru will share knowledge and data related to obesity and weight-management studies with Novo Nordisk. This includes information regarding trial design, methodology and clinical execution, as well as regular updates covering study progress, protocol modifications and safety findings. The collaboration is intended to facilitate efficient study management while expanding understanding of combination approaches in obesity treatment. Veru Retains Global Rights to Enobosarm The company emphasized that it continues to hold full worldwide development and commercialization rights for enobosarm. However, the agreement grants Novo Nordisk a right of first negotiation should Veru seek to develop, commercialize or license intellectual property involving enobosarm in combination with any Novo Nordisk GLP-1 product for any therapeutic indication. The arrangement preserves Veru’s strategic flexibility while establishing a framework for potential future collaboration between the two companies in the growing obesity treatment market. Veru stock price Novo Nordisk stock price Original: Veru Teams Up With Novo Nordisk for Obesity Combination Therapy Trial (HDRN)
glenn1919
1年前
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tw0122
2年前
$1.03 + 19% Veru to Deliver Keynote Presentation on the Scientific Support for Enobosarm in Combination with GLP-1 Receptor Agonist to Preserve Muscle for Higher Quality Weight Loss at the 4th Edition of the World Obesity and Weight Management Congress
Source: GlobeNewswire Inc.
Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced that the Company will present at the World Obesity and Weight Management Congress, taking place October 24-26, 2024, in Baltimore, Maryland.
Keynote Presentation Name: Advancing enobosarm, an oral novel Selective Androgen Receptor Modulator (SARM), to avoid muscle loss and augment fat loss when combined with a Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) drugs for potentially higher quality weight loss
Date: October 25, 2024
Start and end time: 9:40 AM – 10:20 AM Eastern Daylight Time
Location: Best Western Plus Hotel & Conference Center, Baltimore, MD
Additional information on the meeting can be found on the following website: https://obesityworldconference.com/
About the Enobosarm Phase 2b clinical trial
The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial is designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to preserve muscle and augment fat loss in 168 patients with sarcopenic obesity or overweight elderly (>60 years of age) patients receiving semaglutide (Wegovy®). The primary endpoint is total lean body mass, and the key secondary endpoints are total body fat mass and physical function as measured by stair climb test at 16 weeks. The Phase 2b clinical trial is actively enrolling patients from up to 15 clinical sites in the United States. Topline clinical results from the trial are expected in January of 2025.
After completing the efficacy dose-finding portion of the Phase 2b clinical trial, it is expected that participants will then continue in blinded fashion into a Phase 2b extension clinical trial where all patients will stop receiving a GLP-1 RA, but will continue taking placebo, enobosarm 3mg, or enobosarm 6mg for an additional 12 weeks. The Phase 2b extension clinical trial will evaluate whether enobosarm can maintain muscle and prevent the fat and weight gain that occurs after discontinuing a GLP-1 RA. The topline results of the separate blinded Phase 2b extension clinical study are expected in calendar Q2 2025.
About Sarcopenic Obesity
According to the CDC, 41.5% of older adults have obesity in the United States and could benefit from a weight loss medication. Up to 34.4% of these obese patients over the age of 60 have sarcopenic obesity. This large subpopulation of sarcopenic obese patients is especially at risk for taking GLP-1 drugs for weight loss as they already have critically low amount of muscle due to age-related muscle loss. Further loss of muscle mass when taking a GLP-1 RA medication may lead to muscle weakness leading to poor balance, decreased gait speed, mobility disability, loss of independence, falls, bone fractures and increased mortality which is a condition like age-related frailty. Because of the magnitude and speed of muscle loss while on GLP-1 RA therapy for weight loss, GLP-1 RA drugs may accelerate the development of frailty in older obese or overweight elderly patients.
About Enobosarm
Enobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), a novel oral daily selective androgen receptor modulator (SARM), has been previously studied in 5 clinical studies involving 968 older normal men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer. Advanced cancer causes the loss of appetite where there is significant unintentional loss or wasting of both muscle and fat mass which is similar to what is observed with in patients taking GLP-1 RA drugs. We believe the totality of the clinical data from these previous five clinical trials demonstrates that enobosarm treatment leads to dose-dependent increases in muscle mass with improvements in physical function as well as significant dose-dependent reductions in fat mass. The patient data that were generated from these five enobosarm clinical trials in both elderly patients and in patients with a cancer induced appetite suppression provide strong clinical rationale for enobosarm. The expectation is that enobosarm in combination with a GLP-1 RA would potentially augment the fat reduction and total weight loss while preserving muscle mass.
Enobosarm has a large safety database, which includes 27 clinical trials involving 1581 men and women, some of which included patients dosed for up to 3 years. In this large safety database, enobosarm was generally well tolerated with no increases in gastrointestinal side effects. This is important as there are already significant and frequent gastrointestinal side effects with a GLP-1 RA treatment alone.
About Veru Inc.
Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin.
Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 ENABLAR-2 clinical trial of enobosarm and abemaciclib for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting.
Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The Company does not intend to undertake further development of sabizabulin for the treatment of viral-induced ARDS until we obtain funding from government grants, pharmaceutical company partnerships, or other similar third-party external sources.
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