Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease

A Randomized, Double-Blind, Placebo-Controlled Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects With Gout and Mild to Moderate Chronic Kidney Disease

The purpose of this Phase IIa study is to evaluate the safety, tolerability and pharmacodynamics of ALLN-346 in subjects with hyperuricemia and gout, and with mild to moderate chronic kidney disease.

This is a randomized, double-blind, placebo-controlled parallel group, multi-center phase II clinical study or orally administered ALLN-346 in subjects with hyperuricemia, gout and mild to moderate chronic kidney disease over a two-week period. Subjects will be enrolled in two cohorts based on estimated glomerular filtration rate (eGFR).

Inclusion Criteria:

• Male or female, age 18 to 70 years
• Serum UA level ≥ 8.0 mg/dL at Screening (hyperuricemia)
• Meets 2015 American College of Rheumatology (ACR)/EULAR criteria for gout
• Screening eGFR of ≥60 - <90 mL/minute/1.73 m2 for Cohort A and ≥30 - <60 mL/minute/1.73 m2 for Cohort B.
• Concomitant medications stable for a minimum of 4 weeks prior to and during Screening
• Body Mass Index (BMI) ≥ 18 and ≤ 40 kg/m2, inclusive, at screening
• Not pregnant, not capable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation

Exclusion Criteria:

• Currently taking any oral urate-lowering medication within 2 weeks prior to Screening
• Prior uricase therapy or exposure to recombinant uricase, such as Rasburicase or Pegloticase
• Gout flare requiring treatment within 14 days prior to or during Screening
• Clinically significant finding during Screening, any ongoing clinically significant illness requiring a clinically significant intervention or change in management within 4 weeks prior to or during Screening
• History of GI surgery, including gastric sleeve, Roux-en-Y or gastric banding (unless gastric band removed for a minimum of 12 months prior to Screening
• Received treatment with or exposure to an Investigational drug or device within 30 days - prior to or during Screening
• Prior dosing in ALLN-346 clinical study
• Per Investigator judgment, is not an ideal clinical study candidate