Alba Therapeutics's AT-1001 gains FDA fast-track designation

By Angela McDaniels

Seattle, Oct. 26 - Alba Therapeutics Corp. said it has successfully completed the first phase-one trial for its drug candidate AT-1001 and won fast-track designation for the compound from the U.S. Food and Drug Administration.

Alba said it plans to begin a proof-of-concept study demonstrating the efficacy of AT-1001 for treating patients with Celiac disease in the next few months.

The fast-track process is designed to speed the development and review of new drugs with the potential to address significant unmet medical needs for the treatment of serious or life-threatening conditions, the company said.

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.

Alba is a biopharmaceutical company based in Baltimore, Md. that concentrates on disease-modifying therapeutics and drug delivery adjuvants based on the zonulin pathway.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.