Lipella Pharmaceuticals announces FDA Type C meeting for LP-10

Lipella Pharmaceuticals announced that the U.S. Food and Drug Administration has granted a Type C meeting request to discuss the company’s proposed Phase-2b clinical trial design for the evaluation of LP-10, an intravesical liposomal formulation of tacrolimus, as a potential treatment for moderate to severe hemorrhagic cystitis. Lipella expects to meet with the FDA on May 21, 2024. HC is a serious, life-threatening form of gross hematuria caused by cancer treatments including pelvic radiation therapy, and certain chemotherapies including cyclophosphamide and ifosfamide, which are most commonly used for the treatment of breast cancer. Lipella successfully completed a Phase-2a open-label, dose-escalation clinical trial in early 2023 demonstrating the safety, and the potential efficacy of LP-10 in 13 patients with a history of HC. The study demonstrated preliminary efficacy in multiple measures, including urine microscopy, urinalysis, urinary urgency, as well as a potential dose response in the reduction of bleeding sites observed during bladder cystoscopy. Lipella published these results in the peer-reviewed journal, International Urology and Nephrology, in September 2023, and received preliminary guidance from the FDA regarding potential registration endpoints. The company’s anticipated Type C meeting with the FDA will focus on reaching an agreement for the proposed Phase-2b trial design, which Lipella expects to be a 36-subject, prospective, double-blind, placebo-controlled study with a primary efficacy assessment derived from the reduction in patient-reported frequency of gross hematuria episodes over a seven-day period.