Lipella to Proceed with Phase 2b Clinical Trial in Hemorrhagic Cystitis
Clinical stage biotechnology company, Lipella Pharmaceuticals (Nasdaq: LIPO) has received Type C meeting guidance from the FDA regarding the design of its Phase 2b clinical trial. The FDA provided preliminary agreement on Lipella’s overall trial design, including objectives, safety monitoring, control group monitoring, the dosing protocol, the primary efficacy endpoint, and sample size considerations.
The company will evaluate its lead product candidate, LP-10 (liposomal tacrolimus) as a treatment for hemorrhagic cystitis in approximately 36 patients in the second half of 2024. Lipella has demonstrated preliminary safety and efficacy of LP-10 in a Phase 2a study, which resulted in improved urinary symptoms, including decreased hematuria, decreased cystoscopic bleeding, and a reduced number of ulceration sites.
Commenting on the news, Lipella’s Chief Medical Officer, Dr. Michael Chancellor, said, “We can now proceed with the confidence that our Phase 2b study design can successfully meet its regulatory objectives. This clarity significantly advances our value proposition.”
The expected annual revenue per patient for LP-10 is estimated at $20,000 for each intravesical instillation. With a potential market penetration of 50% among the 60,000 patients suffering from hemorrhagic cystitis each year, the revenue opportunity could reach approximately $1.2 billion annually in the U.S. alone.
Hemorrhagic cystitis is a severe, rare and chronic condition often triggered by pelvic radiation therapy and specific chemotherapies, and characterized by significant urinary blood loss. There are currently no FDA approved treatments for moderate to severe hemorrhagic cystitis, a highly morbid and sometimes fatal condition. Lipella’s LP-10 stands at the forefront of addressing this unmet medical need.
About Lipella Pharmaceuticals
Lipella 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, the company maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella recently completed an initial public offering in December 2022. For more information, visit www.lipella.com or LinkedIn for updates.
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