Intravesical Liposome Treatment for Interstitial Cystitis

DESCRIPTION (provided by applicant): Interstitial cystitis (IC) is a chronic, severely debilitating disease of the urinary bladder. It can be described as a chronic inflammatory condition of the bladder wall, characterized by urinary frequency and urgency, and severe suprapubic and/or pelvic pain. Presently, there is limited medical therapy for IC and new and effective treatment is a major unmet medical need. Lipella Pharmaceuticals Inc. intends to be the leading company specializing in the use of intravesical liposome technology to treat IC. We have developed a method of formulating highly specific liposomes for intravesical instillation. The technology is licensed from inventions and research by Drs. Leaf Huang and Michael Chancellor at the University of Pittsburgh. Based on their research that a liposome itself can provides a soothing effect to an irritated bladder, Lipella Pharmaceuticals expects that intravesical liposome formulations can present an improved activity in patients with IC. Lipella Pharmaceuticals currently has a number of liposome compositions that demonstrate efficacy in treating induced bladder irritation in a rat model. The most promising compound, LPA-08, is the subject of this grant proposal. The specific composition of LPA-08, and initial efficacy results in rats, indicate that LPA-08 shows promise as a safe and effective therapy for bladder irritation. The effort proposed here would, in part, contribute to pre-clinical data collection prior to filing an FDA Investigational New Drug (IND) application, a regulatory requirement prior to administering LPA-08 in man. Such efforts include exploring the pharmacology of LPA-08, as well as its distribution post- instillation. We propose key preclinical experiments in an animal model to validate follow-on inves ment for clinical development of a novel treatment for painful bladder syndrome, an in-curable chronic illness involving pain, urinary urgency, loss of sleep, depression and anxiety in approximately 500,000 women domestically.