Lipella Pharma Sees Positive Results for LP-10 Phase 2a Trial
PITTSBURGH, Jan. 11, 2023 /MarketWatch/
Lipella Pharmaceuticals Inc. said it saw positive top-line results from its recently completed Phase 2a clinical trial evaluating the safety and efficacy of its drug candidate LP-10 for hemorrhagic cystitis.
The biotechnology company said its next step will be to communicate with the Food and Drug Administration on the study’s results and the pathway forward to seeking regulatory approval for LP-10.
The study 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.
All subjects tolerated the LP-10 instillations and completed the study without report of product-related serious adverse events. LP-10 pharmacokinetic analysis demonstrated short duration of systemic uptake, decreased cystoscopic bleeding and ulceration sites, and improved patients’ urinary symptoms.
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