Adicet Bio (NASDAQ:ACET) on Wednesday said that the U.S. Food and Drug Administration has granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis, sending shares up in early trade.
Adicet Bio (ACET) stock climbed +5.14% premarket to $1.43.
“The FDA’s decision to grant ADI-001 Fast Track Designation for lupus nephritis underscores the urgent need for new therapies for this chronic disease,” said Chen Schor, President and Chief Executive Officer of Adicet Bio (ACET).
“We plan to initiate our Phase 1 clinical study in lupus nephritis later this month,” Adicet Bio (ACET) said.
With clinical data for ADI-001 in non-Hodgkin’s lymphoma demonstrating CD19+ B-cell depletion that mirrors data by autologous alpha-beta CAR T in academic clinical studies in several autoimmune diseases, Adicet Bio (ACET) believes the company is positioned to expand its autoimmune program to address additional indications beyond lupus nephritis.
Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need.
Source: Press Release