New York, December 20, 2023 – Clinical-stage biotechnology company, Lipella Pharmaceuticals (Nasdaq: LIPO) is celebrating a year of strategic accomplishments on its first anniversary as a public company. Lipella is advancing three clinical indications and has been granted two Orphan Drug Designations by the US Food and Drug Administration (FDA).
Today, the company announced it has successfully completed a Type C meeting with the FDA, focused on the clinical program for LP-10, Lipella’s lead product candidate for the treatment of hemorrhagic cystitis (HC).
Commenting on the meeting, Lipella’s Chief Executive Officer, Jonathan Kaufman, PhD., said, “The FDA’s feedback from our recent Type C meeting gives us a clear path forward into 2024. Our planned Phase-2b trial for LP-10 will involve 36 subjects in a double-blind, placebo-controlled study, focusing on the treatment’s impact on gross hematuria.”
LP-10 has been evaluated in a multi-center Phase 2a dose escalation trial of 13 subjects with moderate to severe refractory HC. Positive top line results demonstrated safety and efficacy, short duration of systemic uptake, and a dose response including decreased hematuria, decreased cystoscopic bleeding and ulceration sites, and improved urinary symptoms in patients.
Lipella’s Chief Medical Officer, Dr. Michael Chancellor, reflected on the year’s achievements, commenting, “Our first year as a public company, especially during challenging market conditions, has been remarkable. Heading into 2024, we are enthusiastic about advancing our assets through clinical trials, bolstered by two orphan designations.”
During 2023, Lipella achieved a number of critical milestones:
- The company received FDA clearance and central Institutional Review Board (IRB) approval for its Investigational New Drug (IND) application for a Phase 2a multicenter trial of an oral rinse formulation of LP-310, targeting Oral Lichen Planus (OLP) and is now selecting study sites for this trial.
- Lipella was granted orphan drug designation for LP-310 in the treatment of oral graft-versus-host disease (GVHD) with tacrolimus and expects to submit a Phase 2a IND for this indication in the first quarter of 2024.
- The company delivered results from its successful Phase 2a clinical trial evaluating LP-10 for the treatment of HC at Biotech Showcase in January, followed by additional detail in a late-breaking presentation at the annual meeting of the American Urologic Association in April 2023.
HC is a severe rare condition often triggered by pelvic radiation therapy and specific chemotherapies, and characterized by gross hematuria (blood in the urine). There is no approved drug treatment and Lipella’s LP-10 stands at the forefront of addressing this unmet medical need.
About Lipella Pharmaceuticals Inc.
Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications. Additionally, Lipella maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella completed its initial public offering in December 2022. For more information, please visit www.lipella.com or LinkedIn.
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