Allena Pharmaceuticals, Inc. reported that it has dosed the first patient in a second Phase 2a trial of ALLN-346 (the ALLN-346 202 Trial), a novel, orally-administered, urate-degrading enzyme in development for the treatment of gout in patients with chronic kidney disease (CKD). The Phase 2a program, comprised of this two-week outpatient trial and a one-week inpatient trial currently being conducted in a clinical pharmacology unit, is designed to assess initial bioactivity data and additional safety data for ALLN-346, the second orally delivered, non-absorbed enzyme developed using Allena's proprietary oral enzyme technology platform. The Phase 2a Program for ALLN-346: The Phase 2a trial (Study 202) announced an outpatient study expected to enroll 24 hyperuricemic patients with gout and mild-to-moderate chronic kidney disease. Patients are to be randomized (2:1) to receive either five capsules of ALLN-346 or matching placebo, three times daily, during a two-week treatment period. Of the two cohorts of 12 patients each, the first cohort will consist of patients with an eGFR (estimated glomerular filtration rate) of 60-89 mls/minute, and the second will consist of patients with an eGFR of 30-59 mls/minute. The other Phase 2a trial (Study 201), initiated in July, is a one-week study conducted in a clinical pharmacology unit (CPU) setting enrolling patients with hyperuricemia. Patients are randomized (2:1) to receive either ALLN-346 or matching placebo. Dosing of ALLN-346 for the initial cohort of approximately 12 patients is five capsules of ALLN-346 three times daily, with the dose level of ALLN-346 for any additional cohorts to be determined based upon data from the first cohort. For both studies, key bioactivity endpoints will include measurements of serum uric acid and urine uric acid. Both studies will also assess safety and tolerability in the hyperuricemia, gout and chronic kidney disease patient populations.