Lipella Pharmaceuticals Announces Enrollment of First Patient in Phase-2 Trial in Interstitial Cystitis
Lipella has enrolled and treated the first patient in a 36-subject, Phase-2a, U.S. clinical trial designed to evaluate the safety and efficacy of LP-08 in patients with Interstitial Cystitis
Pittsburgh, PA (PRWEB) August 27, 2015
Lipella Pharmaceuticals Inc. today announced dose administration for the first patient in a Phase-2 clinical study testing its liposomal formulation (LP-08) in 36 subjects diagnosed with Interstitial Cystitis, an incurable, chronic, and debilitating disease of the urinary bladder that involves urinary urgency, frequency and chronic pelvic pain. The study will assess the safety and tolerability of two dose levels of LP-08 compared to placebo.
The study is comprised of two parts. The first part of the study is a dose-ranging, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of LP-08 at 20 mg and 80 mg doses compared to placebo. The second part of the study is an Open Label Extension study of the safety, tolerability and efficacy of an LP-08 80 mg dose. For further study details, refer to the following link to ClinicalTrials.gov: Link
The initiation of the Phase-2a study follows the successful conclusion of an open-label clinical trial evaluating LP-08 in 14 subjects. In this prior study, a course of four weekly intravesical instillations of LP-08 was associated with statistically significant improvements in pelvic pain and urgency scores four weeks beyond the completion of treatment. These benefits were not accompanied by treatment-associated adverse events. This positive outcome was published in the journal International Urology and Nephrology.
About Lipella Pharmaceuticals Inc.
Lipella Pharmaceuticals is a biopharmaceutical company focused on the development of new drugs to treat patients with urinary bladder diseases and disorders. More information is available at http://www.lipella.com.
Lipella Pharmaceuticals Inc.
Source: Lipella Pharmaceuticals Inc.
Peters KM, et al. Liposomal bladder instillations for IC/BPS: an open‐label clinical evaluation. International Urology and Nephrology 46(12):2291-2295, 2014.
The project described is supported by Award Number R44D0K85733 from the National Institute of Diabetes And Digestive And Kidney Diseases. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Diabetes And Digestive And Kidney Diseases or the National Institutes of Health.