Equillium Granted U.S. FDA Fast Track Designation for EQ001

Equillium (Nasdaq:EQ), a biotechnology company developing treatments for severe immuno-inflammatory disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EQ001 for the treatment of acute graft-versus-host disease (aGVHD).

As quoted in the press release:

“FDA Fast Track designation of EQ001 highlights the significant need for novel approaches for the first line treatment of aGVHD in combination with corticosteroids and positions Equillium to rapidly advance a promising treatment to patients suffering with this common complication after hematopoietic stem cell transplant,” said Krishna Polu, M.D., chief medical officer of Equillium. “We are excited about this important achievement and believe the opportunity for more frequent dialog with the FDA will benefit the efficient development of EQ001 in aGVHD. Our team is working closely with investigators and trial sites to rapidly prepare for dosing of the first patients in the EQUATE trial early next year.”

“Graft-versus-host disease is a very serious immuno-inflammatory condition that is the leading cause of non-relapse related mortality in patients undergoing allogeneic hematopoietic stem cell transplantation and aGVHD is an area of major unmet clinical need,” said John Koreth, M.D., director of Translational Research for Stem Cell Transplantation at Dana-Farber Cancer Institute, who is the lead investigator of the EQUATE clinical trial. “Safe and effective therapies are needed for the treatment of this life-threatening complication.  We are very excited to participate in the EQUATE trial for the treatment of aGHVD with EQ001, which carries forward some of the pioneering work conducted at the Dana-Farber by Drs. Jerome Ritz and Robert Soiffer that elucidated the role of CD6+ T effector cells in the development of aGVHD. An anti-CD6 targeted approach has the potential to improve outcomes in patients who develop aGVHD and I look forward to leading the EQUATE trial to evaluate the safety and activity of EQ001 in these patients.”

Click here to read the full press release.