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Veru Announces Successful FDA Meeting Providing Regulatory Clarity for Enobosarm for Muscle Preservation in Combination with GLP-1 RA for Greater Weight Loss in the Treatment of Obesity
Globenewswire· 2025-09-23 12:30
Core Viewpoint - Veru Inc. has received regulatory clarity from the FDA regarding enobosarm, a selective androgen receptor modulator, as a muscle preservation drug candidate in combination with GLP-1 RA for obesity treatment, allowing incremental weight loss as an acceptable primary endpoint for approval [2][3][5]. Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases, with enobosarm and sabizabulin as key drug candidates [9]. FDA Meeting Highlights - The FDA has indicated that incremental weight loss with enobosarm added to GLP-1 RA treatment is an acceptable primary endpoint for approval [2]. - Enobosarm 3mg has been confirmed as an acceptable dosage for future clinical development [2]. - The FDA has encouraged the expansion of the enobosarm development program to include younger populations with obesity [2]. Clinical Development Program - The Phase 2b PLATEAU clinical study will evaluate the effect of enobosarm 3mg on total body weight, physical function, and safety in approximately 180 older and younger patients initiating tirzepatide treatment for weight reduction [6][8]. - The primary efficacy endpoint is the percent change from baseline in total body weight at 72 weeks, with key secondary endpoints including total fat mass, total lean mass, and physical function [7]. Phase 2b QUALITY Study Insights - The Phase 2b QUALITY study demonstrated that enobosarm treatment preserved lean mass and improved physical function while leading to greater fat loss during the 16-week active weight loss period [3][10]. - Enobosarm monotherapy was able to prevent weight regain by 46% after discontinuation of semaglutide, resulting in greater fat loss compared to the placebo group [3]. Weight Loss Plateau Context - The weight loss plateau occurs when patients on GLP-1 RA stop losing weight; approximately 88% of patients in the SURMOUNT-1 study reached this plateau by 72 weeks [4]. - Combining tirzepatide with enobosarm is expected to lead to additional fat loss by preserving muscle and physical function, particularly in older patients [4].
Veru Announces Novel Modified-Release Oral Formulation for Enobosarm
ZACKS· 2025-08-15 14:21
Company Developments - Veru Inc. has selected a novel modified-release oral formulation of enobosarm for chronic weight loss management, which aims to enhance fat loss while preserving lean mass [1][4] - The new formulation was developed in collaboration with Laxxon Medical, utilizing proprietary SPID-Technology for advanced oral delivery profiles [2][3] - The modified-release formulation achieved a distinct target product release profile, including a reduction in maximum plasma concentration and a delayed time to maximum plasma concentration [3] - Veru holds a robust patent estate for the new formulation, with protection extending through 2037 and potential expiry of new patent applications expected in 2046 [4] Clinical Study Results - In a Phase 2b clinical study, enobosarm monotherapy reduced weight regain by 46% compared to placebo after discontinuation of semaglutide, while completely preventing fat regain and preserving lean mass [5] Industry Insights - The global anti-obesity drug market was valued at $4.51 billion in 2023 and is projected to grow at a compound annual growth rate of 25.5% through 2032, driven by the increasing prevalence of obesity [6] - Several companies, including Regeneron Pharmaceuticals and Eli Lilly, are advancing obesity treatments, indicating a competitive landscape in the anti-obesity drug market [7][9]
Veru Reports Fiscal 2025 Third Quarter Financial Results and Clinical Program Progress
Globenewswire· 2025-08-12 10:30
Core Insights - The company reported positive efficacy and safety data from the Phase 2b QUALITY study, indicating that enobosarm combined with semaglutide led to muscle preservation, increased fat loss, and fewer gastrointestinal side effects compared to semaglutide alone [1][3] - The Phase 2b Maintenance Extension study showed that enobosarm significantly reduced body weight regain and fat regain while preserving lean mass after discontinuation of semaglutide [1][7] - A novel modified release oral formulation of enobosarm has been selected for further clinical studies following a pharmacokinetic clinical study [1][9] Clinical Development - The Phase 2b QUALITY study involved 168 older patients (≥60 years) and demonstrated that the 3mg enobosarm dose preserved 100% of total lean mass compared to placebo + semaglutide at 16 weeks (p<0.001) [4][8] - Enobosarm treatment resulted in a 42% greater relative loss of fat mass with the 6mg dose compared to placebo + semaglutide at 16 weeks (p=0.017) [4][8] - The study found that 44.8% of the placebo + semaglutide group experienced at least a 10% decline in stair climb power, indicating a risk of physical function loss [5][8] Safety and Efficacy - Enobosarm plus semaglutide treatment maintained similar mean body weight loss as semaglutide alone while preserving lean mass [4][7] - The enobosarm 3mg monotherapy significantly reduced body weight regain by 46% after semaglutide discontinuation [8] - The safety profile of enobosarm was positive, with no gastrointestinal side effects or evidence of drug-induced liver injury observed [8][9] Financial Overview - As of June 30, 2025, the company reported cash, cash equivalents, and restricted cash of $15.0 million, down from $24.9 million as of September 30, 2024 [12][19] - Research and development expenses decreased to $3.0 million from $4.8 million year-over-year [15][21] - The net loss from continuing operations decreased to $7.3 million, or $0.50 per share, compared to $10.3 million, or $0.71 per share in the previous year [15][22]
Veru Announces Selection of Novel Modified Release Oral Enobosarm Formulation for Chronic Weight Loss Management Following Pharmacokinetic Clinical Study
Globenewswire· 2025-08-11 12:30
Core Insights - Veru Inc. has selected a novel modified release oral formulation of enobosarm for chronic weight loss management after confirming pharmacokinetic endpoints in a clinical study [1][2] - The new formulation aims to improve the pharmacokinetic profile of enobosarm, including reduced maximum plasma concentration and delayed time to maximum plasma concentration [2][3] - The formulation is protected by a robust patent estate, with existing patents extending through 2037 and new applications potentially extending to 2046 [3] Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on innovative medicines for cardiometabolic and inflammatory diseases, with enobosarm and sabizabulin as key drug candidates [4] - Enobosarm is a selective androgen receptor modulator being developed to enhance fat loss while preserving lean mass, particularly in older patients [4][5] Clinical Development - The Phase 2b QUALITY clinical study showed positive results for enobosarm in augmenting fat loss and preventing muscle loss in older patients receiving semaglutide [5][6] - The maintenance extension study confirmed that enobosarm significantly reduced body weight regain and preserved lean mass after discontinuation of semaglutide [6][7] - The company has been granted an FDA meeting to discuss its Phase 3 program for enobosarm [8] Collaboration and Technology - The novel formulation was developed in collaboration with Laxxon Medical, utilizing proprietary SPID-Technology for advanced oral delivery profiles [3][4] - Laxxon Medical is recognized for its innovative drug delivery systems and holds a significant patent portfolio, enhancing the commercialization potential of the new formulation [9][10][12]
Veru Announces Reverse Stock Split
Globenewswire· 2025-08-06 12:30
Core Viewpoint - Veru Inc. is implementing a 1-for-10 reverse stock split to regain compliance with Nasdaq's minimum bid price requirement of $1.00, which was approved by shareholders on July 25, 2025 [3]. Group 1: Reverse Stock Split Details - The reverse stock split will take effect at 11:59 pm CT on August 8, 2025, with trading on a split-adjusted basis starting on August 11, 2025 [1]. - All outstanding stock options and equity incentive plans will be proportionally affected, with every 10 shares converting into 1 share without changing the par value of $0.01 per share [2]. - No fractional shares will be issued; shareholders will receive cash payments for any fractional shares [2]. Group 2: Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on innovative medicines for cardiometabolic and inflammatory diseases [6]. - The company's drug development includes enobosarm, a selective androgen receptor modulator aimed at improving body composition, and sabizabulin, a microtubule disruptor for treating inflammation in cardiovascular disease [6].
Veru to Report Fiscal 2025 Third Quarter Financial Results on August 12th
Globenewswire· 2025-08-05 12:30
Core Viewpoint - Veru Inc. is preparing to discuss its fiscal 2025 third quarter financial results and provide a business update during a conference call on August 12, 2025 [1] Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [3] Enobosarm Obesity Program - Enobosarm is being developed as a next-generation drug to enhance fat loss while preserving lean mass, making weight reduction more tissue-selective when used with GLP-1 RA drugs [4] - The Phase 2b QUALITY clinical study showed positive topline and safety results, evaluating enobosarm in older patients receiving semaglutide for chronic weight management [4][5] - The study confirmed that enobosarm significantly reduced body weight regain and preserved lean mass after discontinuation of semaglutide treatment [6] Clinical Trials and FDA Interaction - The company has been granted a meeting with the FDA to discuss its Phase 3 program for enobosarm [7]
Veru to Participate in the 2025 BTIG Virtual Biotech Conference
Globenewswire· 2025-07-22 12:30
Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [2] - The company's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [2] Enobosarm Obesity Program - Enobosarm is being developed as a next-generation drug to enhance fat loss while preserving lean mass, particularly in older patients receiving semaglutide for chronic weight management [3][4] - The Phase 2b QUALITY clinical study showed positive topline and safety results, with participants losing an average of 11.88 lbs during the active weight loss period [4] - After discontinuation of semaglutide, the placebo group regained 43% of lost body weight, while the enobosarm 3mg and 6mg groups regained only 1.41% (2.73 lbs) and 2.87% (5.29 lbs) respectively, demonstrating a significant reduction in weight regain [4][5] - Enobosarm monotherapy preserved more than 100% of lean mass compared to the placebo group, which experienced a loss of lean mass [5][6] Sabizabulin Atherosclerosis Inflammation Program - Sabizabulin is being explored for the treatment of inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [8][9] - The drug has shown broad anti-inflammatory activity in previous clinical studies, with a safety database consisting of 266 dosed patients [8][9] - The company believes that combining sabizabulin with statin therapy could effectively reduce inflammation and slow the progression of atherosclerotic cardiovascular disease [8][9] Upcoming Events - Veru Inc. will participate in one-on-one meetings and a fireside chat presentation with investors at the 2025 BTIG Virtual Biotech Conference on July 29-30, 2025 [1]
Veru Reports Positive Results from Phase 2b QUALITY and Maintenance Extension Study Showing Enobosarm Significantly Reduced Body Weight Regain, Prevented Fat Regain, and Preserved Lean Mass After Semaglutide Discontinuation
Globenewswire· 2025-06-24 12:30
Core Insights - Veru Inc. announced positive topline efficacy and safety results from the Phase 2b QUALITY clinical study, particularly highlighting the effectiveness of enobosarm in weight management after discontinuing semaglutide treatment [1][15] - Enobosarm 3mg significantly reduced body weight regain by 46% and completely prevented fat regain compared to placebo, while preserving lean mass [1][4] - The company has been granted a meeting with the FDA to discuss advancing enobosarm into Phase 3 clinical trials [1][15] Efficacy Results - In the placebo group, participants regained 43% of the body weight lost during the initial study phase after stopping semaglutide, while the enobosarm 3mg group regained only 1.41% (2.73 lbs) [1][4] - Enobosarm treatment resulted in up to 93% greater fat loss and 100% preservation of lean mass compared to the placebo group at the end of the study [1][4][6] - The enobosarm plus semaglutide regimen preserved 100% of lean mass, with 99% of body weight loss attributed to fat [2][5] Safety Profile - Enobosarm monotherapy maintained a positive safety profile with essentially no gastrointestinal side effects observed during the maintenance period [1][10] - There were no significant adverse events related to liver injury or increases in prostate-specific antigen levels, and no reports of suicidal ideation were noted [11][12] Study Design - The Phase 2b Maintenance Extension study involved 148 participants who discontinued semaglutide and received either placebo, enobosarm 3mg, or enobosarm 6mg for 12 weeks [3][15] - The study aimed to assess the role of enobosarm in preserving lean mass and preventing weight regain after stopping semaglutide [3][8] Future Outlook - The company anticipates reporting full Phase 2b QUALITY and Maintenance Extension clinical trial data at leading scientific conferences and in publications [2][15] - Enobosarm is positioned as a next-generation drug that enhances weight reduction by GLP-1 RA drugs, focusing on fat loss while preserving lean mass [14][15]
Veru to Participate in the Virtual BTIG Obesity Health Forum
Globenewswire· 2025-06-11 12:30
Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [2] - The company's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [2] Enobosarm Development - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by making GLP-1 RA drugs more tissue selective for fat loss while preserving lean mass [2] - Positive topline and safety results were announced from the Phase 2b QUALITY clinical study, which involved 168 older patients (≥60 years) receiving semaglutide for chronic weight management [3] - The Phase 2b extension study will evaluate whether enobosarm can prevent fat regain after stopping GLP-1 RA treatment, with topline results expected in Q2 2025 [3] Sabizabulin Development - Sabizabulin is being explored as a treatment for inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [4][5] - The drug has shown broad anti-inflammatory activity in previous clinical studies, with a safety database consisting of 266 dosed patients [4][5] - The company plans to submit a new IND for sabizabulin's proposed indication by the first half of 2026 [6] Market Opportunity - The decision to explore sabizabulin for atherosclerotic cardiovascular disease is based on the large global market opportunity and the high probability of success due to its mechanism of action being similar to colchicine [5] - The company aims to assess the progression of coronary atherosclerosis using coronary CT angiography imaging as a primary endpoint in a small Phase 2 proof of concept study [5]
创新药周报20250602:贝莫苏拜+安罗替尼 VS K药1L NSCLC III期成功
Huachuang Securities· 2025-06-03 00:25
Investment Rating - The report indicates a positive investment rating for the innovative drug sector, particularly highlighting the success of the combination therapy of Bemesumab and Anlotinib in treating NSCLC [8][11]. Core Insights - The report emphasizes the significant progress in the treatment of non-small cell lung cancer (NSCLC) through innovative therapies, particularly the combination of immune checkpoint inhibitors and anti-angiogenic agents, which have shown improved progression-free survival (PFS) rates compared to traditional therapies [7][11]. - The CAMPASS trial demonstrated that the combination of Bemesumab and Anlotinib significantly extended the median PFS to 11.0 months compared to 7.1 months for the control group, marking a notable advancement in first-line treatment options for PD-L1 positive advanced NSCLC [11]. - The report also discusses the ongoing clinical trials and the potential for new drug approvals, indicating a robust pipeline for innovative therapies in the oncology sector [12][47]. Summary by Sections Section 1: Focus on Innovative Drugs - The report reviews the latest developments in innovative drugs, particularly in the context of NSCLC treatments and highlights the importance of combination therapies [2][3]. Section 2: Clinical Trial Results - The report details the results of the CAMPASS trial, which compared the efficacy of Bemesumab combined with Anlotinib against Pembrolizumab in treating advanced NSCLC, showcasing a significant improvement in PFS [11][12]. - It also covers the mid-term analysis of the TQB2450-III-12 trial, which further supports the efficacy of the Bemesumab and Anlotinib combination in squamous NSCLC [13]. Section 3: Market Developments - The report notes the recent approvals and submissions for new drug indications, reflecting a dynamic and rapidly evolving market for innovative cancer therapies [45][49]. - It highlights the performance of various biotech companies in the market, indicating significant fluctuations in stock prices and market capitalization [41][43].