Resurge Therapeutics, a privately held therapeutics company, announced promising six-month clinical results from the initial dose cohort of the ongoing first-in-human study evaluating its novel IntraProstatic Drug Elution (IPDE) therapy. The novel therapy demonstrated meaningful improvements in both symptom severity and urinary flow rates in men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
The results were presented by Flavio Ordones, M.D., of Tauranga, New Zealand, at the American Urology Association Annual Meeting held April 26-29, 2025, in Las Vegas. Ordones' presentation received the “Best in Session” award in the BPH New Technology track.
The multicenter, multinational dose escalation study enrolled patients with confirmed symptomatic BPH, including both irritative and obstructive LUTS and reduced urinary flow. All participants received a single administration of the IPDE therapy. At the six-month mark, the international prostate symptom score improved by an average of 11 points from baseline, while maximum urinary flow rate improved by an average of 5 milliliters per second. Pain scores were minimal, with a mean of zero at discharge. No drug-related or procedural serious adverse events were reported.
“In the U.S. alone, an estimated 40 million men are affected by BPH, with 8 million currently on daily medications – many of whom are unsatisfied with current treatment options,” said Shahram Gholami, M.D., co-founder of Resurge Therapeutics. “Our early clinical results suggest the novel IPDE therapy has the potential to offer durable symptom relief in a single treatment, without the side effects of either oral drugs or surgical procedures and also without the adherence challenges of daily medications.
About IPDE and Resurge Therapeutics
The IPDE therapy is designed to deliver sustained, localized drug release directly to the prostate through a one-time administration. Follow-up evaluations are ongoing, and Resurge plans to release additional data as it becomes available. The company will collaborate with the U.S. Food and Drug Administration to advance the IPDE therapy into further clinical studies and ultimately toward marketing approval.
Resurge Therapeutics was co-founded by Mikael Trollsas, John Stankus and Shahram Gholami. The company is dedicated to pioneering transformative drug delivery therapies that address major unmet needs in urology.
Media Contact:contact@resurgetherapeutics.com
https://c212.net/c/img/favicon.png?sn=SF95629&sd=2025-05-27
View original content:https://www.prnewswire.com/news-releases/resurge-therapeutics-announces-compelling-six-month-clinical-results-from-novel-prostate-drug-delivery-therapy-302464645.html
SOURCE Resurge Therapeutics
https://rt.newswire.ca/rt.gif?NewsItemId=SF95629&Transmission_Id=202505270901PR_NEWS_USPR_____SF95629&DateId=20250527