Taris Biomedical has begun enrolling subjects for a Phase II clinical study designed to test its unusual LiRIS drug delivery system in patients with the bladder condition known as interstitial cystitis.
The Lexington, MA company plans to enroll up to 161 women with interstitial cystitis in a double-blind, mult-center, randomized, placebo controlled study that will evaluate the system's impact on bladder pain, urgency, voiding frequency and other interstitial cystitis-related symptoms. LiRIS, known formally as the Lidocaine Releasing Intravescical System, includes semi-permeable silicone tubes inserted into the patient to deliver extended release of lidocaine directly to the bladder, to relieve symptoms such as bladder pain and voiding dysfunction. It is the company's lead product candidate.
Interstitial cystitis, which is also known as bladder pain syndrome, has no known cause and can leave patients urinating up to 60 times a day, Taris said. The condition affects mostly women, as many as 8 million in the U.S. alone.
LiRIS's advance into later-stage clinical trials is a big milestone, in part because of the technology's enormous potential benefit compared to existing treatments.
A typical existing option involves filling a catheter with lidocaine, which lasts only about an hour because a patient discharges it after needing to urinate. Oral treatment alternatives can be ineffective and cause side effects, Taris notes on its website.
Taris' drug delivery device, by contrast, is deployed through a cystoscope and can deliver lidocaine for weeks before it is eventually removed. Related procedures, in theory, would not need additional anesthesia and could be done in a doctors office, Xconomy noted in previous coverage of the company.
Taris is yet another company launched based on technology developed by Massachusetts Institute of Technology scientists Robert Langer and Michael Cima.
Taris raised $18.3 million in series B financing in April--money that will fuel the Phase II study.
- here's the release
- check out previous Xconomy coverage