ALBA THERAPEUTICS ANNOUNCES COMPLETION OF FIRST HUMAN TRIAL FOR AT-1001

Alba Therapeutics has announced the successful completion of its first Phase I trial for the drug candidate AT-1001, and that the FDA has granted fast-track designation to AT-1001 for treatment of Celiac disease. Alba plans to begin a proof of concept study demonstrating efficacy of AT-1001 in celiac patients within the next few months.

The fast-track process is designed to facilitate development and expedite the review of new drugs with the potential to address significant unmet medical needs for the treatment of serious or life-threatening conditions. Potential fast-track benefits include FDA input into development, submitting new drug applications in sections rather than all at once and the option of requesting accelerated approval.