First patient dosed in second Phase 2 study with LiRIS for treatment of Interstitial Cystitis

TARIS Biomedical®, a specialty pharmaceutical company developing innovative, targeted therapies to treat bladder diseases with high unmet medical need, announced today that it has dosed the first patient in its second Phase 2 clinical study with LiRIS®, its novel product candidate, in patients with Interstitial Cystitis (IC). LiRIS® is designed to continuously deliver lidocaine over an extended period directly to the bladder of patients with IC, to relieve the painful and often debilitating symptoms associated with this disease.

“We anticipate this new study will provide necessary data that will enable us to design a successful registration program. Interstitial Cystitis continues to be a significant unmet medical need, and we believe our technology can fundamentally change the treatment of this debilitating condition.”

"TARIS®' first Phase 2 study provided important insights into both the disease and the benefit of LiRIS relative to placebo in this patient population. This new study incorporates these learnings," said J. Curtis Nickel, MD, FRCSC, Professor of Urology, Queens University, Canada, and the trial's principal investigator. Dr. Purnanand Sarma, PhD, President and CEO of TARIS® said, "We anticipate this new study will provide necessary data that will enable us to design a successful registration program. Interstitial Cystitis continues to be a significant unmet medical need, and we believe our technology can fundamentally change the treatment of this debilitating condition."

This multi‐center, randomized, double‐blind, placebo-controlled Phase 2 clinical study will evaluate the safety and efficacy of LiRIS® in up to 124 patients with Interstitial Cystitis. Patients who successfully complete the randomized trial will be eligible to participate in a subsequent open-label extension arm where all patients are eligible to receive LiRIS®. TARIS® plans to conduct this study in up to 15 investigational sites in the US and Canada.

In a separate release issued today, TARIS Biomedical® also announced that it has closed a $12.5M financing, led by its existing investors, Flagship Ventures, Flybridge Capital Partners, Polaris Partners and Third Rock Ventures.

In addition to Interstitial Cystitis, TARIS® is developing a pipeline of novel, targeted therapies designed to treat a variety of bladder diseases, such as bladder cancer and urinary incontinence, utilizing its novel targeted bladder delivery system.