Allena Pharmaceuticals, Inc. 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). 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. The Phase 2a program, comprised of a one-week inpatient trial (Study 201) and a two-week outpatient trial (Study 202), is designed to assess initial bioactivity data and additional safety data for ALLN-346, the second orally delivered, non-absorbed enzyme developed using the company?s proprietary oral enzyme technology platform. Study 201 is a one-week study being conducted at a clinical pharmacology unit enrolling patients with hyperuricemia. Patients are to be randomized (2:1) to receive either five capsules of ALLN-346 or matching placebo three times daily. Study 202 is a two-week, outpatient study expected to enroll 24 hyperuricemic patients with gout and mild-to-moderate CKD. Patients are to be randomized (2:1) to receive either five capsules of ALLN-346 or a matching placebo three times daily. Of the two currently planned cohorts of 12 patients each, one cohort will consist of patients with an estimated glomerular filtration rate (eGFR) of 60-89 mL/minute (CKD Stage 2), and the other will consist of patients with an eGFR of 30-59 mL/minute (CKD Stage 3). For both studies, key bioactivity endpoints will include measurements of serum urate and urine uric acid. Both studies will also assess safety and tolerability in the hyperuricemia, gout and CKD patient populations. The company plans to report initial data from these studies beginning 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.