Veru (VERU) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Key insights on muscle loss and weight loss drugs

• GLP-1s and similar weight loss drugs cause significant muscle loss, with 20%-50% of lost weight being muscle, especially concerning for older adults who already have reduced muscle reserves.

• Loss of muscle impacts not only physical function but also metabolic health, contributing to issues like the 'Ozempic plateau' and rebound weight gain after stopping medication.

• Recent clinical data show increased risk of falls and fractures in older patients using GLP-1s, highlighting the clinical relevance of muscle preservation.

• Bariatric surgery and GLP-1s both show that most muscle loss occurs early in treatment, making the first 12-16 weeks critical for intervention.

Enobosarm as a companion therapy

• Enobosarm, a selective androgen receptor modulator, is designed to preserve or increase muscle mass and strength without the side effects of testosterone.

• Clinical trials show enobosarm increases lean body mass and leg strength, with notable results in postmenopausal women and obese patients.

• In obese patients, enobosarm can reduce fat and overall weight while maintaining muscle, making it suitable for combination with GLP-1s.

• Enobosarm also improves bone health and metabolic markers, such as glucose and insulin resistance.

Clinical trial design and regulatory focus

• The ongoing Phase 2 QUALITY trial is testing enobosarm in combination with GLP-1s in older, obese patients, with primary endpoints of lean body mass and functional stair climb tests.

• The trial uses a sensitive stair climb test with added weight to assess functional improvement, aligning with FDA guidance on endpoints.

• Extension studies will assess whether enobosarm can blunt rebound weight gain after stopping GLP-1s, with data expected in early 2025.

• FDA prioritizes functional outcomes over cosmetic muscle gain, and enobosarm has demonstrated improvements in both muscle mass and function.