Lipella’s Liposome Formulation of Botulinum Toxin (LP-09) Superior to Placebo for Overactive Bladder Symptoms in Double-Blind Trial

PITTSBURGH--(BUSINESS WIRE)--Pittsburgh based Lipella Pharmaceuticals Inc. today announced newly published results of a multi-site, double-blind, placebo-controlled clinical trial comparing the bladder instillation of a botulinum toxin in liposome formulation (LP-09) to placebo in 62 subjects diagnosed with overactive bladder (OAB). In the study, instillation of LP-09 showed significant clinical benefit without an increased risk of side effects. These results are published here in The Journal of Urology and are consistent with an earlier LP-09 clinical study previously reported here. The successful trial indicates the growing potential of LP-09 as a promising approach for the treatment of OAB.

“We are excited to continue the development LP-09 for not only OAB, but also for interstitial cystitis.”

 

 

OAB is a urological condition associated with urinary frequency and urgency that affects millions of Americans. While there are approved oral pharmacotherapies for OAB, there remains an unmet medical need for patients who stop oral therapy for lack of efficacy, adverse side-effects, or both. These patients increasingly turn to alternative therapies including neuromodulation and botulinum toxin needle injections during cystoscopy into the urinary bladder. LP-09 is a proprietary topical-liposome-botulinum-toxin formulation that does not require needle injections or cystoscopy.

The LP-09 clinical trial was physician sponsored and conducted at Buddhist Tzu Chi General Hospital and Kaohsiung Chang Gung Memorial Hospital in Taiwan. In the study, a single intravesical instillation of LP-09 was associated with statistically significant improvement in urinary frequency, and urgency severity score for LP-09 vs. placebo four weeks post instillation. These results were not accompanied by an increased post void residual urine volume.

“This is the second controlled clinical study of LP-09 where a dose of LP-09 significantly improved OAB symptoms without increasing residual urine volume,” said Dr. Michael Chancellor, Chief Medical Officer of Lipella. “We are excited to continue the development LP-09 for not only OAB, but also for interstitial cystitis.”

About Lipella Pharmaceuticals Inc.

Lipella Pharmaceuticals Inc., the developer of LP-09, is a specialty biopharmaceutical company focused on the development of topical liposomal formulations for multiple therapeutic applications, including Interstitial Cystitis, Hemorrhagic Cystitis, and Overactive Bladder. LP-09 is not currently approved for commercial use in any indication in the United States. Further company details are available at www.lipella.com.

Citation

Chaung YC, et al. Bladder Instillation of Liposome Encapsulated OnabotulinumtoxinA Improves Overactive Bladder Symptoms- A Prospective Multi-center Double Blind Randomized Trial. J Urol. 2014 Dec;192(6):1743-9