TARIS commences LiRIS Phase 1B clinical study in interstitial cystitis

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.

“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.”

"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."