Equillium got U.S. FDA’s Fast Track designation for itolizumab for the treatment of lupus nephritis, after startign the phase 1 study of itolizumab in patients with lupus and lupus nephritis in September 2019.
The FDA’s Fast Track program is designed to facilitate the development of new treatments for serious or life-threatening conditions for which there is a significant unmet medical need. Companies with investigational drugs that receive Fast Track designation benefit from more frequent meetings or communications with the FDA to discuss the drug’s development plan and may be eligible for accelerated approval and priority review.
Krishna Polu, chief medical officer said that receiving Fast Track designation recognizes the promising therapeutic potential of itolizumab for the treatment for lupus nephritis, particularly given its ability to modulate both the activity and trafficking of effector T cells. He said: “Additionally, by monitoring levels of the CD6-ALCAM pathway in the urine in the EQUALISE trial we will be assessing the opportunity to take a personalized medicine approach to identify patients where the CD6-ALCAM pathway may be a dominant driver of the disease.”
Kenneth Kalunian, the lead principal investigator on the EQUALISE trial added that lupus nephritis, is a complication of systemic lupus, and a devastating disease that affects roughly 100,000 patients in the United States. He said that the existing immunosuppressive therapies have improved five-year survival for lupus nephritis patients, its still more than half that don’t have an adequate response to treatment, and many progress to end-stage renal disease requiring dialysis or transplant. “There are no FDA approved therapies for lupus nephritis; however, the evaluation of itolizumab provides optimism that we may alleviate this significant unmet medical need for lupus nephritis patients,” he said.