Interstitial Cystitis (IC) is an inflammatory disease marked by hemorrhages in the bladder wall that allow urinary irritants to penetrate the underlying tissue and cause further damage. LP-08 works by coating the irritated bladder mucosal layer with a protective lipid barrier to reduce inflammation and promote healing.

Unlike other liposomal therapies, LP-08 is empty—its components are found abundantly in all animals, including humans. Consisting of sphingomyelin phospholipid bilayers separated by aqueous compartments, LP-08 binds to sphingomyelin in the bladder wall, forming a lipid barrier.

In repeated clinical trials, L8-08 reduced IC-related pain and urinary urgency with no adverse effects reported. In pre-clinical studies, serum analysis showed no trace of the drug or related metabolites, indicating that LP-08 treatment has no systemic impact.

Shown here are the results of a clinical trial published recently in the International Journal of Urology and Nephrology. They show the combined levels of pain and urinary urgency reported by 14 patients at baseline, and then at two points following a course of LP-08 treatment.

After receiving four weekly bladder instillations of LP-08, patients were asked to rate their pain and urgency at four weeks (blue line) and eight weeks (green line). Notice that the total pain and urgency scores are significantly lower after treatment with LP-08. In the case of pain, after four weeks, the vast majority of patients found relief. At both intervals, the most-likely pain score for the population shifted from 5.9 to 1.2 (an 80 percent reduction). Similarly, the most-likely urgency severity score for the population shifted from 5.4 to 2.3 (a 57 percent reduction).

A new LP-08 placebo-controlled, dose-ranging study was recently funded by the National Institutes of Health.