LEXINGTON, Mass.--(BUSINESS WIRE)--TARIS Biomedical®, a specialty pharmaceutical company pioneering the development of innovative, targeted therapies using drug delivery to treat bladder diseases with high unmet medical need, announced that it has initiated a Phase 1B clinical study in patients with interstitial cystitis (IC). The study will evaluate the safety and tolerability of TARIS’ innovative product candidate LiRIS® in patients suffering from moderate-to-severe IC. LiRIS® is designed to continuously deliver lidocaine over an extended period directly to the bladder to decrease symptoms associated with IC, such as bladder pain and voiding dysfunction.
“TARIS is developing a pipeline of novel, targeted therapies designed to treat a variety of bladder diseases with high unmet medical need, which leverages common, minimally-invasive urologic procedures to deliver and maintain drug directly to target tissues. Interstitial cystitis is the first of many bladder diseases in which TARIS’ technology could provide tremendous value to patients. Beyond interstitial cystitis, our technology platform has applications in overactive bladder, bladder cancer and others,” said Sarma Duddu, Ph.D., President and CEO, TARIS Biomedical®. “The initiation of this Phase 1B clinical study builds upon a previously completed Phase 1A study in which we successfully established proof-of-concept by demonstrating the tolerability and retention of the TARIS delivery device in the bladder.”
“A major challenge in the treatment of bladder diseases is the delivery of therapeutic agents at sufficient concentrations for the amelioration of bladder symptoms while minimizing systemic adverse effects, commented J. Curtis Nickel, MD, FRCSC, Professor of Urology, Queens University, Canada. While intravesical instillation of therapeutic solutions is a clinically practiced standard of care, effectiveness is limited by its duration of effect, often requiring multiple dosing regimens. There is significant unmet need for therapeutics that enable local sustained delivery of drug directly to the target tissue.”
About Bladder Disease
Bladder diseases, which are difficult to treat with systemic therapies, affect 60 million people in the U.S. alone. These diseases include interstitial cystitis (IC)/painful bladder syndrome (PBS), bladder cancer, overactive bladder, urinary tract infections and chronic pelvic pain syndromes.
About Interstitial Cystitis (IC)/Painful Bladder Syndrome (PBS)
Interstitial Cystitis (IC)/Painful Bladder Syndrome (PBS) are complex bladder diseases associated with significant pain and disability, as well as urinary urgency and/or frequency. People with severe cases of IC/PBS may urinate 25-60 times a day, including frequent nighttime urination, also called nocturia. IC/PBS can dramatically impact quality of life, including loss of work and reduced sexual intimacy; it is associated with suicidal rates five-to-seven times the national average. New therapeutic options for IC/PBS are desperately needed. As many as 15 million people in the U.S. alone experience symptoms consistent with IC/PBS (RAND Interstitial Cystitis Epidemiology (RICE) study, 2009; Parsons, 2004), for which only two medications are approved, both associated with significant limitations.
About TARIS Biomedical®
TARIS Biomedical Inc., a specialty pharmaceutical company with deep domain expertise in therapeutics and drug-delivery, is focused on developing a pipeline of novel therapeutics designed to leverage common, minimally invasive urologic procedures to deliver and maintain drug directly to target tissues. The TARIS core technology and development efforts are being applied to disease areas with high unmet medical need in which current therapies or systemic treatments have failed, with an initial focus on the genitourinary system, specifically for the treatment of bladder diseases. It’s most advanced product candidate, LiRIS® is currently in Phase 1B clinical development for the treatment of interstitial cystitis (IC). Based in Lexington, MA, TARIS Biomedical’s technology was developed by internationally renowned scientists from the Massachusetts Institute of Technology, Robert Langer and Michael Cima, and is backed by leading venture capital firms Flagship Ventures, Flybridge Capital Partners and Polaris Venture Partners. For more information, visit www.tarisbiomedical.com.