It is with a heavy heart that we announce that Allergan has apparently abandoned work with LiRIS, the first treatment in history to heal the worst form of IC, Hunner’s lesions, in some patients. Dr. Daniel Radecki, Executive Director of Clinical Development at Allergan, shared the news that “The LiRIS program has been deprioritized” in an email a few days ago.
Deprioritization essentially means that the company has decided to invest their funds elsewhere in the company. Though Dr. Radecki didn’t explain why this decision was made, it is probably related to profitability or poor research results. The IC marketshare is significantly smaller than the cosmetic, vision or menopause market that Allergan has specialized in. We also have not seen the latest round of research results.
Because the ICN assisted with LiRIS clinical trial promotions, I can offer that it was very difficult to find enough patients to fill the Hunner’s lesion study in 2017. Allergan had entry requirements that made some patients reluctant to participate. At one point, they would not allow patients using daily pain medication to participate, an unrealistic and fairly laughable requirement given that these patients often suffer with severe pain. Would a Hunner’s lesion patient voluntarily stop pain medicine to participate? Most would not.
Another key issue was the lack of anesthesia offered by some investigators during required hydrodistention with cystoscopy procedures. As tens of thousands of patients can attest, having your bladder distended is remarkably painful, especially if you have lesions (aka ulcers) on the bladder wall. At the time, I advised Allergan staff that the American Urology Association Guidelines for IC/BPS strongly suggest that anesthesia be used. They, however, said that it was up to each individual research center. Again, patients had every right to balk at that requirement. I wouldn’t have agreed to do it.
I reached out to Taris Biomedical, the company that invented LiRIS and asked if they might revisit working with interstitial cystitis. Jody Kalt replied this morning and said “We share your interest in the LiRIS program. The full ownership of the program sits with Allergan at this time – TARIS does not have the ability to continue work on the program independent of them.”
If you are a patient who has benefited from LiRIS therapy, we hope that you will take to social networking to ask Allergan to reconsider this decision. We began our campaign this morning!