Sumitomo Pharma Shares Urology and Oncology Data at AUA 2024

Sumitomo Pharma America, Inc. (SMPA) recently shared data from their Phase 3 study, URO-901-3005, at the American Urological Association (AUA) Annual Meeting. This study evaluated the effectiveness, safety, and tolerability of vibegron (GEMTESA) in men with overactive bladder (OAB) who were also receiving treatment for benign prostatic hyperplasia (BPH). The findings were subsequently published in the Journal of Urology.

The study involved approximately 1,100 men experiencing OAB symptoms while undergoing pharmacological therapy for BPH. Participants were randomly assigned to receive either vibegron (75 mg daily) or a placebo over a 24-week period. Statistically significant and clinically meaningful improvements were observed in all primary and secondary endpoints. By Week 12, notable reductions were seen in the average number of daily urination episodes (-2.04 compared to -1.30 for the placebo) and urgency episodes (-2.88 compared to -1.93 for the placebo). These improvements were evident as early as Week 2 and persisted through Week 24.

Dr. Janet Owens-Grillo, Executive Director of Clinical Research at SMPA, emphasized the significance of these findings, noting that no current treatments exist for persistent OAB symptoms in men undergoing BPH treatment. Vibegron also met all secondary endpoints by Week 12. These included significant reductions in nocturia episodes, urge urinary incontinence episodes, and the International Prostate Symptom Score (IPSS)-storage score. Additionally, there was a significant increase in the volume voided per micturition. Throughout the study, vibegron was well-tolerated and demonstrated a safety profile comparable to placebo, with no new safety concerns.

Quality of life assessments using the overactive bladder questionnaire (OAB-q) indicated significant improvements in scores from baseline compared to placebo at both Week 12 and Week 24. Despite these promising results, the use of GEMTESA in men with OAB symptoms receiving BPH treatment has not yet been approved by regulatory authorities.

SMPA, in collaboration with Pfizer, also presented a poster on a discrete choice experiment related to advanced prostate cancer. The study explored patient preferences between oral and injectable androgen deprivation therapy (ADT). Results suggested that patients showed a preference for an oral option regardless of their prior experience with injectable treatments. This highlights the necessity for enhanced education on treatment options and improved communication between patients and healthcare providers.

Adele Gulfo, CEO of the Biopharma Commercial Unit at SMPA, expressed pride in the company's commitment to advancing scientific and therapeutic solutions for patients with limited or no options. The data shared at the AUA Annual Meeting underscored SMPA's dedication to addressing unmet urological conditions.

Vibegron, a β3 adrenergic receptor agonist, is being investigated for treating men with OAB symptoms who are also receiving pharmacological therapy for BPH in the U.S. Currently, GEMTESA is approved for treating OAB symptoms in adults, including urge urinary incontinence, urgency, and urinary frequency. Vibegron functions by selectively targeting β3 adrenergic receptors, helping to relax the bladder detrusor muscle and increase bladder capacity. The drug is also under investigation in China for the treatment of OAB.

Overactive bladder involves involuntary contractions of the bladder muscle, leading to symptoms like urinary urgency, urgency incontinence, and frequent urination. This condition affects around 33 million adults in the U.S. Benign prostatic hyperplasia, a condition characterized by an enlarged prostate, affects many men, particularly as they age, with symptoms often overlapping with OAB.

Sumitomo Pharma, a global pharmaceutical company, operates in various regions, focusing on oncology, urology, women's health, rare diseases, psychiatry, neurology, and cell and gene therapies. Their goal is to accelerate the development of novel therapies to meet patient needs.