The Food and Drug Administration (FDA) has granted Fast Track designation to ALLN-346 for the treatment of hyperuricemia in gout patients with advanced chronic kidney disease.

ALLN-346 is an investigational, first-in-class, nonabsorbed, orally-administered enzyme that breaks down urate in the gastrointestinal tract. In a recently completed phase 1b multiple ascending dose study ( Identifier: NCT04829435), ALLN-346 was found to be well tolerated with no evidence of systemic absorption. The Company believes that ALLN-346 has the potential to treat hyperuricemia and lower the risk of urate-related complications.  

The Company is currently evaluating the safety, tolerability, and pharmacodynamics of ALLN-346 in patients with hyperuricemia and chronic kidney disease in a phase 2a clinical program that consists of 2 trials: Study 201 ( Identifier: NCT04987242) and Study 202 ( Identifier: NCT04987294). Initial data from these studies are expected in late 2021 or early 2022.

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“We are delighted to have received Fast Track designation for ALLN-346,” said David J. Clark, MD, 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.”

The FDA’s Fast Track designation allows for expedited review of therapies that are meant to treat serious or life-threatening conditions. Generally, the designation is granted to therapies that are expected to have an impact on factors such as survival and daily functioning.


Allena Pharmaceuticals receives Fast Track designation from FDA for the development of ALLN-346 for chronic treatment of hyperuricemia in patients with gout and advanced chronic kidney disease. News release. Allena Pharmaceuticals, Inc. Accessed November 3, 2021.

This article originally appeared on MPR