Allena Pharmaceuticals Gets Fast Track Designation for Kidney Disease Treatment
November 03 2021 - 8:45AM
Dow Jones News
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
(END) Dow Jones Newswires
November 03, 2021 08:30 ET (12:30 GMT)
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