Developing Intravesical Liposomes for Interstitial Cystitis

简介（由申请人提供）：Lipella Pharmaceuticals Inc. （Pittsburgh， PA）是一家临床阶段的制药公司，专门从事膀胱功能障碍的膀胱内治疗。Lipella正在向小企业技术转移项目提交一份名为“开发用于间质性膀胱炎的膀胱内脂质体”的研究提案。本项目拟在一项新的临床研究中评估一种名为LP- 08的实验性药物用于间质性膀胱炎/膀胱疼痛综合征（IC/BPS）适应症的安全性和有效性。该提案分为两个具体目标，支持执行lipella赞助的IIB期随机临床试验，以评估与安慰剂剂量相比，两种不同剂量的LP-08在IC/BPS患者中的作用。IC/BPS是一种鲜为人知的疾病，有大量未满足的医疗需求。LP-08是一种脂质体制剂，通过导尿管直接输送到膀胱。脂质体是由磷脂双层组成的囊泡，由水室隔开。LP-08的预期主要作用是减轻IC/BPS引起的患者的刺激和疼痛。这项STTR的成功完成将为一种治疗衰弱综合征的新疗法提供重要的临床数据，并极大地改善将该产品推向市场的前景。

DESCRIPTION (provided by applicant): 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.