Equillium Inc. said the U.S. Food and Drug Administration granted fast-track designation for its drug EQ001 for treating a complication of stem cell transplants.
EQ001 is under development to treat acute graft versus host disease, or aGVHD, which occurs after stem cell transplant procedures and causes diarrhea, skin rashes and liver damage. The severity of the disease varies among patients but can be life-threatening in some cases.
Equillium plans to start a phase 1b/2 study in early 2019 named Equate to evaluate the safety, tolerability and clinical activity of EQ001 in patients with aGVHD.
The fast-track designation will qualify Equillium to meet and communicate more frequently with the FDA during the development of EQ001. It will also allow for the accelerated approval and priority review of the drug's application.
The San Diego, Calif.-based biotechnology company develops products for autoimmune and inflammatory disorders.