The U.S. Food and Drug Administration granted orphan drug designations to San Diego-based Equillium’s drug candidate for the prevention and treatment of a tissue disease.
EQ001 is aimed at acute graft-versus-host disease, or aGVHD, which can cause vomiting, difficulty breathing and other issues. It occurs after a transplant, when immune cells from the donor attack the host patient’s tissues.
With the designations, Equillium is eligible for clinical research tax credits, an FDA fee waiver and an additional seven years of market exclusivity, if the drug is approved.
“Acute GVHD is a life-threatening condition faced by up to 50 percent of those who have undergone a hematopoietic stem cell transplant, and there are currently no approved therapies for either the prevention or treatment of aGVHD,” said Stephen Connelly, chief scientific officer of Equillium, in a statement. “Receiving both FDA Orphan Drug designations for EQ001 underscores the grave need for new treatment options.”
The company plans to start a phase 1b/2 clinical trial in early 2019, which will test EQ001 in combination with corticosteroids, which are drugs for inflammation.
The company in October raised $71.6 million in an initial public offering, skipping the steps that generally come before an IPO. Check out this San Diego Business Journal profile for more.