Lipella Pharmaceuticals Granted Type C Meeting for Rare Disease Candidate

Clinical stage biotechnology company, Lipella Pharmaceuticals (Nasdaq: LIPO) has been granted a Type C meeting request by the FDA. The company expects to meet with the regulator on May 21, 2024 to discuss its proposed Phase 2b clinical trial design for the evaluation of its lead candidate LP-10.

Lipella is developing LP-10 as a potential treatment for moderate to severe hemorrhagic cystitis (HC), a rare and life-threatening bladder condition that can occur months, and even years, after pelvic radiation therapy or bladder-toxic chemotherapy. Its symptoms can be debilitating and include urinary bleeding, urinary pain and incontinence.

“We are eager to advance our LP-10 program efficiently, and our scheduled FDA meeting in the second quarter of 2024 will play a pivotal role in enhancing the regulatory prospects of LP-10,” commented Dr. Michael Chancellor, Lipella’s Chief Medical Officer.

Lipella successfully completed a Phase 2a study of LP-10 in 2023, demonstrating its safety, and potential clinical efficacy in 13 patients with a history of HC. The company’s proposed Phase 2b study is expected 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.

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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Lipella Pharmaceuticals Granted Type C Meeting for Rare Disease Candidate

Catie Corcoran

Biotech Editor