Lipella Pharma Announces Top Line Results In Phase 2A Trial Of LP-10 For Hemorrhagic Cystitis
(RTTNews) - Biotechnology company Lipella Pharmaceuticals Inc. (LIPO) announced top line results for its recently completed Phase 2a clinical trial evaluating the safety and efficacy of its drug candidate LP-10 for Hemorrhagic Cystitis, a rare but highly morbid disease for which there are currently no FDA approved treatments.
The LP-10 Phase 2a clinical trial was a multi-center, dose-escalation study, which recruited 13 subjects with moderate to severe refractory hemorrhagic cystitis. These subjects were treated with up to two courses of LP-10 intravesical bladder instillations.
The top line results indicated that all subjects tolerated LP-10 instillations and completed the study without report of product related serious adverse events. LP-10 pharmacokinetic analysis also demonstrated short duration of systemic uptake. There were also decreased hematuria, decreased cystoscopic bleeding and ulceration sites and improved patients' urinary symptoms.
Further, the responder analysis noted complete response in 3 subjects, partial response in 7 subjects and no response in 3 subjects.
As it next step, the company said it will communicate with the U.S. Food and Drug Administration (FDA) on the study's results and the pathway forward to seeking regulatory approval for LP-10. If approved, it will be a first-in class treatment for the cancer survivor community with hemorrhagic cystitis.
For More Such Health News, visit rttnews.com
Lipella Pharma Soars 48% After FDA Oks IND For LP-310 For Oral Lichen Planus
U.S. Dollar Ticks Lower As Investors Monitor Developments In Middle East
TSX Drops Nearly 2.5%; Materials, Tech Stocks Down Sharply
Swiss Market Ends Modestly Higher
Major European Markets End Mixed As Investors React To Earnings, Economic Data
Chicago Business Barometer Pulls Back But Still Indicates Growth In October
Colgate-Palmolive Q3 Results Rise, Lifts FY26 Base Business EPS View; Stock Gains
