Lipella Pharmaceuticals announced that the results of its successful Phase 2a clinical trial have been the published in the peer-reviewed Journal of Urology and Nephrology. The article highlights the clinically meaningful efficacy and safety profile of Lipella’s lead product candidate, LP-10 as a potential treatment for hemorrhagic cystitis. LP-10 has received Orphan Disease Designation from the US Food and Drug Administration (FDA) for the treatment of hemorrhagic cystitis, a potentially fatal disease with great unmet need and no currently approved drug treatment. Lipella is scheduled to have a Type-C meeting with FDA in Q4 and expects to initiate a Phase 2b clinical trial for LP-10 in January 2024. Pharmacokinetic analysis demonstrated a very short duration of systemic uptake and symptomatic improvements including: decreased hematuria, decreased cystoscopic bleeding, a reduced number of ulceration sites, and improved urinary symptoms.
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