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.
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