Benzinga | Nov 3, 2021 09:17AM EDT

Allena Pharmaceuticals Says Receives Fast Track Designation From FDA For Development Of ALLN-346 For Chronic Treatment Of Hyperuricemia In Patients With Gout And Advanced Chronic Kidney Disease

Allena Pharmaceuticals, Inc. (NASDAQ:ALNA) ("Allena" or the "Company"), a late-stage biopharmaceutical company deploying its novel oral biologic platform to discover, develop and commercialize first-in-class, oral enzyme therapeutics for difficult-to-treat metabolic diseases, today announced that its orally-administered, urate-degrading enzyme, ALLN-346, has received Fast Track designation from the U.S. Food and Drug Administration (FDA). ALLN-346 is in Phase 2 development for the treatment of hyperuricemia in gout patients with advanced chronic kidney disease (CKD).

"We are delighted to have received Fast Track designation for ALLN-346," commented, David J. Clark, M.D., Chief Medical Officer of Allena. " ALLN-346 has a novel mechanism of action for this indication as it is designed to exert its effect in the intestinal tract, leading us to believe that this oral biologic may represent a meaningful new approach to treat gout patients with advanced chronic kidney disease, if approved. With approximately 500,000 patients in the U.S. affected by both disorders, this is an area of high unmet medical need. The timing of this news is also fortuitous with many of our advisors in the nephrology and rheumatology communities gathering virtually for the American Society of Nephrology and American College of Rheumatology meetings this week."

In gout patients with advanced CKD, the intestinal tract becomes the primary route of elimination for urate, and ALLN-346 is specifically designed to capitalize on this physiologic adaptation by enhancing the breakdown and secretion of urate in the intestinal tract. Currently available therapies are either dose-limited or contraindicated in this challenging patient population due to safety and tolerability concerns.

Robert Terkeltaub, M.D., Professor of Medicine, University of California, San Diego School of Medicine and scientific advisor to Allena Pharmaceuticals, noted, "Hyperuricemia and gout in the setting of advanced CKD are not only more difficult to treat, but also are associated with higher risk of progression to end-stage renal disease (ESRD). Currently available urate-lowering therapies are limited in their use for CKD patients based on dosing restrictions, tolerability and safety concerns, and reduced effectiveness, compared to options for the broader gout population. By directly breaking down uric acid in the intestinal tract, ALLN-346 has the potential to provide a well-tolerated new therapeutic tool, if approved, for this difficult-to-treat patient population."