We finally have explanation as to why the LiRIS drug delivery device was “deprioritized.” In September, the data for the final studies was released and showed that it was not successful in reducing IC symptoms, pain and, ideally, the quantity of lesions.
LiRIS was a medical device developed by Taris Biomedical (now Johnson & Johnson) to deliver continuous medication to the bladder over a two week period. Also known as the “lidocaine pretzel”, this hollow noodle like device was filled with lidocaine and then inserted into the bladder via the urethra where it delivered continuous medication to the bladder wall. Once treatment was completed, it was then removed again via urethra. Both the concept and the technology have the potential of revolutionizing the treatment of various bladder disease, especially the treatment of bladder cancer and UTI.
LiRIS was originally intended as a treatment for bladder pain and utilized lidocaine as the medication. In the first Phase 1B “proof of concept” trial, researchers reported a remarkable finding that changed the scope of their studies. Every lesion patient in that small study experienced reduction and/or resolution of their Hunner’s lesions.(1) Had they found a new therapy for lesions?
Jill Osborne, IC Network founder, shared “One of the original participants in that study called my office and shared that her lesions had disappeared and her pain was gone after just two weeks of treatment. Up to that point, I had never heard of LiRIS and immediately called the company for information. I eventually had a meeting the CEO of the company. His enthusiasm was palpable but he asked that I not discuss the data until they published their results. I was, admittedly, very excited for this patient population who are in desperate need of new treatments.”
Top IC researchers in the USA, including Robert Evans (NC), Robert Moldwin (NY) and others, were intrigued by the early data and joined in the clinical trials.
Allergan Funded Studies Failed
Pharmaceutical giant Allergan bought LiRIS from Taris for an estimated $300 million dollars with the goal of bringing it through FDA approval and to market.(3) They funded two phase 2 studies to assess the efficacy and safety of lidocaine-releasing intravesical system (LiRIS) in IC/BPS patients with or without Hunner’s lesions. Both studies were multicenter, randomized, double-blind, placebo-controlled, and enrolled women aged ≥18 years.
In total, 190 patients received the treatment and their results were disappointing. LiRIS showed no statistically significant difference in pain, frequency and urgency symptoms.(2) There was also no clear trend for reduction in number of Hunner’s lesions for LiRIS vs placebo. Sadly, these studies did not demonstrate a treatment effect of LiRIS 400 mg compared with placebo, either in patients with IC/BPS with HL, or in those without HL.
We don’t know why the Allergan studies failed or if the original study was flawed in some way. There was some concern about the Allergan clinical trial entry requirements as they initially excluded patients who required pain medication as well as participants in previous LiRIS studies. At least one patient in California refused to participate after discovering that the doctor was planning on doing a hydrodistention with cystoscopy in their office without anesthesia. Are these relevant? Probably not.
The LiRIS drug delivery system is a remarkable medical device that could revolutionize the treatment of bladder cancer, recurring UTI and perhaps, in the future, interstitial cystitis. Johnson & Johnson certainly recognized its potential when they purchased Taris Biomedical in December of 2019.(4) Let’s hope that they have more luck than the IC researchers.
1. Peters K, et al. Safety, Tolerability and Preliminary Efficacy of LiRIS 400mg in Women With Ulcerative IC. AUA 2016 Abstract MP72-616
2. Evans R, et al. Safety, Tolerability and Efficacy of LiRIS 400mg in Women with IC/BPS with or without Hunner’s Lesions. Neurourol Urodyn. 2021 Sep;40(7):1730-1739.
3. Allergan Acquires LiRIS Program From Taris Biomedical. Drug Development & Delivery. Allergan Press Release (no date published) https://drug-dev.com/allergan-acquires-liris-program-from-taris-biomedical/
4. Novel Drug Delivery Technology Strengthens Targeted Oncologic Therapy Approach. December 20, 2019. Jannsen Press Release https://www.janssen.com/johnson-johnson-acquires-taris-biomedical-focus-transforming-treatment-bladder-cancer