Allena Pharmaceuticals Inc. (NASDAQ: ALNA) has announced that the FDA has granted its orally delivered, urate degrading enzyme, ALLN-346, a fast track designation.
ALLN-346 is a treatment product currently in Phase 2 development for hyperuricemia in gout treatment for patients with advanced chronic kidney disease. Recently, Allena finalized a phase 1b dose-escalation study of ALLN-346 in healthy volunteers.
Allena receives Fast track Designation for ALLN-346.
The company’s chief medical officer David Clark said, “We are delighted to have received Fast Track designation for ALLN-346. 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.”
The intestinal system becomes the principal route of urate elimination in gout patients with severe CKD, and ALLN-346 is mainly intended to take advantage of this physiologic adaptation by boosting urate secretion and breakdown in the intestinal tract. Unfortunately, due to safety and tolerability concerns, currently available medications are either contraindicated or dose-limited in this challenging patient population.
Hyperuricemia in advanced CKD related to high risk of progression
Allena Scientific Advisor Robert Terkeltaub, “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.”
