Introduction to Enobosarm
Enobosarm, also known as ostarine, MK-2866, GTx-024, and VERU-024, is a novel oral selective androgen receptor modulator (SARM) being developed by Veru Inc. This drug candidate holds promise in several therapeutic areas, including weight loss, oncology, and potentially other indications.
Clinical Development Overview
Weight Loss and Muscle Preservation
Enobosarm is currently in a Phase 2b clinical trial to evaluate its efficacy in preserving muscle mass and physical function, while enhancing fat loss in patients receiving Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs. These GLP-1 RA drugs are highly effective for weight loss but often result in significant muscle loss, which can be detrimental to metabolism, strength, and overall physical function. Up to 50% of the weight lost with GLP-1 RA drugs can come from muscle, highlighting the need for a treatment like enobosarm to maintain muscle mass[2][3].
The Phase 2b clinical trial, known as the QUALITY study, aims to assess whether enobosarm can augment fat loss and prevent muscle loss in sarcopenic obese or overweight elderly patients. The trial has received FDA clearance, and results from the separate Phase 2b open-label extension study are expected in the second quarter of 2025[2][3].
Previous Clinical Data
Enobosarm has been studied in five previous clinical trials involving 968 participants, including older normal men, postmenopausal women, and older patients with muscle wasting due to advanced cancer. These studies demonstrated dose-dependent increases in muscle mass, improvements in physical function, and significant reductions in fat mass. This data provides strong clinical rationale for the ongoing and future trials of enobosarm[2][5].
Oncology Indications
Metastatic Breast Cancer
Veru Inc. is also developing enobosarm for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+), and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer. The company has prioritized the Phase 3 ENABLAR-2 clinical trial, which will evaluate enobosarm in combination with abemaciclib (a CDK 4/6 inhibitor) in the second-line treatment setting. This decision was made to focus on a potentially more responsive patient population earlier in the treatment sequence[4].
The ENABLAR-2 study involves two stages: the first stage will assess the efficacy and safety of enobosarm with or without abemaciclib, and the second stage will enroll approximately 200 subjects to evaluate progression-free survival as the primary endpoint. If the study shows significant improvement in overall response rate (ORR), the company plans to seek an accelerated approval regulatory pathway[4].
Financial and Operational Updates
Funding and Resources
Veru Inc. has secured significant funding to support the clinical trials of enobosarm. The company raised $35.2 million in a public offering, which, combined with its existing cash balance of $40.6 million, is expected to cover the costs of the ongoing and planned clinical trials. This financial stability is crucial for advancing the development of enobosarm without immediate funding constraints[3].
Strategic Focus
Veru Inc. has transformed into a pure biopharmaceutical company by selling its FC2 female condom business for $18 million. This move allows the company to focus exclusively on its pharmaceutical pipeline, with enobosarm being a key priority. The company has also reduced its workforce by 90% to align with its new strategic focus[5].
Market Projection
Potential Market Opportunity
The combination of enobosarm with GLP-1 RA drugs for weight loss represents a significant market opportunity. Given that GLP-1 RA drugs are widely used and effective but come with the drawback of muscle loss, enobosarm could address a critical unmet medical need. This combination therapy has the potential to result in higher quality weight loss by preferentially increasing fat loss while preserving muscle mass and improving physical function. The global market for this indication could be substantial, potentially reaching into the multi-billion dollar range[3].
Competitive Landscape
In the weight loss and muscle preservation market, enobosarm stands out due to its unique mechanism of action as a SARM. Unlike traditional weight loss drugs that often result in muscle loss, enobosarm's ability to maintain or even increase muscle mass while reducing fat makes it an attractive option. In the oncology space, particularly for metastatic breast cancer, the combination of enobosarm with abemaciclib offers a novel therapeutic approach that could differentiate it from existing treatments[4].
Key Takeaways
- Clinical Trials: Enobosarm is in Phase 2b clinical trials for weight loss and muscle preservation, with results expected in Q2 2025.
- Oncology: Enobosarm is being developed for AR+ ER+ HER2- metastatic breast cancer in the second-line setting.
- Financial Stability: Veru Inc. has sufficient funding to complete the ongoing and planned clinical trials.
- Market Potential: The combination of enobosarm with GLP-1 RA drugs and its use in oncology represent significant market opportunities.
- Unique Mechanism: Enobosarm's ability to preserve muscle mass and improve physical function sets it apart in the weight loss and oncology markets.
FAQs
Q: What is enobosarm, and how does it work?
A: Enobosarm is a selective androgen receptor modulator (SARM) that works by targeting androgen receptors to increase muscle mass and reduce fat mass. It is being developed for various indications, including weight loss and metastatic breast cancer.
Q: What are the current clinical trials for enobosarm?
A: Enobosarm is currently in a Phase 2b clinical trial (QUALITY study) to evaluate its efficacy in preserving muscle mass and enhancing fat loss in patients receiving GLP-1 RA drugs. It is also in the Phase 3 ENABLAR-2 clinical trial for the treatment of AR+ ER+ HER2- metastatic breast cancer.
Q: What is the expected market potential for enobosarm?
A: The market potential for enobosarm is significant, particularly in the weight loss and oncology sectors. The combination with GLP-1 RA drugs could represent a multi-billion dollar global opportunity.
Q: How is Veru Inc. funded for the development of enobosarm?
A: Veru Inc. has raised $35.2 million in a public offering and has a cash balance of $40.6 million, which is expected to cover the costs of the ongoing and planned clinical trials.
Q: What other therapeutic areas is enobosarm being explored for?
A: Besides weight loss and metastatic breast cancer, enobosarm is not currently being explored for other therapeutic areas, but its mechanism of action suggests potential applications in conditions involving muscle wasting.
Sources
- Veru Announces Meta-analysis of Body Composition Data from Phase 2b Extension Clinical Trial of Enobosarm. Veru Inc.
- Veru Announces FDA Clearance of IND Application to Initiate Phase 2b Clinical Trial with Enobosarm. GlobeNewswire.
- Earnings call: Veru Inc. announces progress on Enobosarm drug trials. Investing.com.
- Veru Reports Clinical Data from the Discontinued ARTEST Study of Enobosarm. BioSpace.
- Veru Sells FC2 Female Condom Business for $18M. Stock Titan.
Last updated: 2025-01-02
