Lipella Pharmaceuticals Inc. — Department of Health and Human Services STTR Phase II: DESCRIPTION (provided by applicant): Lipella Pharmaceuticals Inc. (Pittsburgh, PA) is a cl
Lipella Pharmaceuticals Inc. — STTR Phase II award from Department of Health and Human Services.
- Amount
- $741,288
- Agency
- Department of Health and Human Services · National Institutes of Health
- Program / Phase
- STTR · Phase II
- Solicitation
- PA13-235
- NAICS
- —
- Place of performance
- PA
- Period
- —
Description
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 aque