Allena Pharmaceuticals Gets Fast Track Designation for Kidney Disease Treatment
8:15 am ET November 3, 2021 (Dow Jones) Print
By Chris Wack
Allena Pharmaceuticals Inc. said its orally-administered, urate-degrading enzyme, ALLN-346, has received Fast Track designation from the U.S. Food and Drug Administration.
ALLN-346 is in Phase 2 development for the treatment of hyperuricemia in gout patients with advanced chronic kidney disease.
The biopharmaceutical company said that 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.
The Phase 2a program is comprised of a one-week inpatient trial and a two-week outpatient trial, designed to assess initial bioactivity data and additional safety data for ALLN-346.
Allena plans to report initial data from these studies in late 2021 or early 2022. Initial data from the Phase 2a program will potentially assist the company in determining the optimal dosing paradigm and target population for later stage clinical trials.
Allena shares were up 11% to 95 cents in premarket trading.
Write to Chris Wack at chris.wack@wsj.com
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