#United States #San Jose #BPH Treatment #Prostate Therapy #Resurge Therapeutics

Resurge Therapeutics Announces Compelling Six-Month Clinical Results from Novel Prostate Drug Delivery Therapy

In a significant advancement for men's health, Resurge Therapeutics has unveiled promising results from its ongoing first-in-human study of the IntraProstatic Drug Elution (IPDE) therapy. This innovative approach is designed to address the challenges posed by benign prostatic hyperplasia (BPH), a condition affecting millions of men worldwide.

The Clinical Study

The initial findings, presented by Dr. Flavio Ordones at the American Urology Association Annual Meeting in Las Vegas, have showcased notable improvements in symptom severity and urinary flow rates in men experiencing lower urinary tract symptoms (LUTS) due to BPH. The study, which is a multicenter and multinational dose escalation trial, involved patients with confirmed symptomatic BPH.

Every participant received a single administration of the IPDE therapy, and at the six-month follow-up, the results were encouraging. The international prostate symptom score demonstrated an average improvement of 11 points from the baseline. Additionally, the maximum urinary flow rate increased by an impressive average of 5 milliliters per second, highlighting the therapy's effectiveness.

What makes these results even more remarkable is the minimal pain reported — with an average score of zero at discharge — and the absence of serious drug-related adverse events. This suggests a high safety profile for the IPDE therapy, which sets it apart from existing treatment options.

The Impacts on Men's Health

Dr. Shahram Gholami, co-founder of Resurge Therapeutics, emphasized the scale of the issue at hand, noting that around 40 million men in the U.S. are affected by BPH, with 8 million currently relying on daily medications that often leave them dissatisfied. The recent clinical findings suggest that the novel IPDE therapy may provide durable relief from symptoms through a single treatment, which would avoid the side effects commonly associated with oral medications and surgical options. Furthermore, it eliminates the need for daily medication adherence, which many patients find challenging.

Understanding IPDE Therapy

The IPDE therapy offers a unique mechanism, delivering localized drug release directly to the prostate. This approach is designed to provide sustained relief from the symptoms of LUTS linked to BPH with a single administration, marking a potential game changer in urological treatment options. Resurge's commitment to advancing this therapy underlines its goal of addressing critical unmet needs within the field of urology.

The company will continue to gather data and plans to collaborate with the U.S. Food and Drug Administration as it progresses towards further clinical studies and marketing approval. Resurge Therapeutics, co-founded by Mikael Trollsas, John Stankus, and Shahram Gholami, is determined to lead innovations in drug delivery systems to improve patient outcomes.

Looking Forward

With the promising early results from the IPDE therapy, Resurge Therapeutics is on the verge of making substantial strides in prostate health treatments. Follow-up evaluations are currently ongoing, and healthcare professionals anticipate additional data that could further substantiate the therapy's potential.

This landmark research underscores the importance of continued innovation in urological treatments and highlights the significant impact that effective therapies can have on the quality of life for millions of men suffering from BPH. As the healthcare community looks toward the future, Resurge Therapeutics stands at the forefront, championing revolutionary approaches that aim to enhance men's health.