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

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 - <60mL/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 effectivemethod 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 orPegloticase
• Gout flare requiring treatment within 14 days prior to or during Screening
• Clinically significant finding during Screening, any ongoing clinically significantillness 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 (unlessgastric band removed for a minimum of 12 months prior to Screening
• Received treatment with or exposure to an Investigational drug or device within 30days - prior to or during Screening
• Prior dosing in ALLN-346 clinical study
• Per Investigator judgment, is not an ideal clinical study candidate