FDA grants fast track designation to Alvine celiac disease therapeutic

Alvine is at present conducting Phase 2 trials with ALV003, an orally administered mixture of two recombinant gluten-specific proteases, a cysteine protease and a prolyl endopeptidase, in conjunction with a gluten-free diet.

ALV003 targets gluten and degrades it into small fragments, which, in vitro, diminishes its immunogenicity.

Alvine president and chief executive officer Abhay Joshi said the fast track designation reflects the potential of ALV003 to address the unmet medical needs of celiac disease patients.

"Building on the data from our earlier phase 2A trial that demonstrated the ability of ALV003 to diminish gluten-induced intestinal injury in well-controlled celiac disease patients, we look forward to pursuing phase 2 and phase 3 trials under the Fast Track program," Joshi added.

With a fast track designation, there is an opportunity for more frequent interactions with the FDA during clinical development and for the possibility of priority review.