Lipella Pharmaceuticals Inc. (Pittsburgh, PA) is a clinical-stage pharmaceutical company specializing in intravesical therapies for urinary bladder dysfunctions. Lipella is submitting a research proposal to the Small Business Technology Transfer program titled "Developing Intravesical Liposomes for Interstitial Cystitis". The project proposes to evaluate the safety and efficacy of an experimental drug, named LP- 08, for the indication of interstitial cystitis/ bladder pain syndrome (IC/BPS) in a new clinical study. The proposal is divided into two specific aims that support the execution of a Lipella-sponsored Phase IIB randomized clinical trial to evaluate two different doses of LP-08 in IC/BPS patients compared to a placebo dose. IC/BPS is a poorly understood condition with significant unmet medical needs. LP-08 is a liposome formulation delivered directly to the bladder via urinary catheter. Liposomes are vesicles composed of phospholipid bilayers separated by aqueous compartments. The intended primary effect of LP-08 is to alleviate irritation and pain caused by IC/BPS in patients. Successful completion of this STTR would provide significant clinical data on a novel therapy for a debilitating syndrome and greatly improve the prospect of bringing the product to market.
This research proposal is for the National Institutes of Health Small Business Technology Transfer (STTR) program. The project is titled Developing Intravesical Liposomes for Interstitial Cystitis and will further the clinical development of a drg to treat interstitial cystitis/ bladder pain syndrome (IC/BPS). Up to one million people in the United States of America suffer from IC/BPS, an incurable, chronic disease of the bladder believed to be caused by defects in the epithelial cells lining the bladder lumen. There is limited medical therapy for IC/BPS. The development of safe and effective new treatment for IC/BPS is a major unmet need for many Americans.