Clinical stage specialty pharmaceutical company Taris Biomedical has begun patient dosing in its second Phase II study with LiRIS, for the treatment of interstitial cystitis (IC).
LiRIS is designed to constantly deliver lidocaine to the bladder of IC patients over an extended period to relieve the painful symptoms associated with the disease.
Queens University, Canada, urology professor and trial principal investigator Dr Curtis Nickel said; "TARIS' first Phase II 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."
The multicentre, randomised Phase II clinical study is designed to assess the safety and efficacy of LiRIS in around 124 patients with interstitial cystitis.
Patients successfully completing the placebo-controlled trial will be eligible for participation in a following open-label extension arm, and will be administered LiRIS.
This study is scheduled to be conducted in up to 15 investigational sites across US and Canada.
Taris president and CEO Dr Purnanand Sarma said; "We anticipate this new study will provide necessary data that will enable us to design a successful registration programe. Interstitial cystitis continues to be a significant unmet medical need, and we believe our technology can fundamentally change the treatment of this debilitating condition."