To evaluate the efficacy and safety of teverelix in treatment naïve patients aged over 50 years with symptomatic benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS), and to explore teverelix' potential in preventing AUR secondary to BPH with the aim to inform a planned Phase 2 trial.
This Phase 2, multicenter, randomized, double-blind, placebo-controlled study involved BPH patients with an International Prostate Symptom Score (IPSS) ≥ 13 and uroflow < 13 mL/sec. After a 4-week single-blind placebo run-in, patients were randomized to receive teverelix 60 mg (n = 41) or placebo (n = 40) subcutaneously on day 1 and day 3. The primary endpoint was IPSS reduction at end of treatment period (Week 16); secondary endpoints included uroflow, prostate volume (PV), pharmacokinetics, pharmacodynamics, quality of life (QoL), and safety. Data were analyzed using analysis of covariance with α set at 0.05.
At Week 16, teverelix significantly reduced IPSS by a mean of 6.3 (SD: ± 3.9) versus 1.1 (SD: ± 2.9) for placebo. By Week 2, teverelix showed a mean IPSS reduction of 13.0% compared to 3.8% for placebo, reaching 34.5% by Week 16 versus 5.2% for placebo. Clinically relevant IPSS reductions were observed in 44% of teverelix patients by Week 2, increasing to 83% by Week 12. Teverelix also achieved a significant 11% reduction in PV within 4 weeks, improved maximum urinary flow rate, and enhanced QoL scores.
Teverelix shows potential as an effective, well-tolerated treatment for LUTS secondary to BPH, with rapid and sustained benefits. The significant prostate volume reduction suggests that teverelix may help prevent recurrent AUR, warranting further dedicated studies.
International urology and nephrology. 2024 Oct 20 [Epub ahead of print]
Albertas Ulys, Aušra Černiauskienė, Petrișor Geavlete, Finn Larsen, Carol M MacLean, Steve van Os
National Cancer Institute, Santariskių Str. 1, LT-08660, Vilnius, Lithuania., Vilnius University Hospital Santariskiu Klinikos, Vilnius, Lithuania., Spitalul Clinic de Urgentia "Sf.Ioan", Bucharest, Romania., Antev Ltd, Ibex House, Baker Street, Weybridge, Surrey, KT13 8AH, UK., Antev Ltd, Ibex House, Baker Street, Weybridge, Surrey, KT13 8AH, UK. .