Ardea Biosciences (RDEA) 8-K Ardea Biosciences Announces Positive End-of-Phase 2 Meetings with FDA for Lesinurad

Long-term

Allopurinol

Safety

Trial

(LASSO)

–

open-label

interventional

studies

of

allopurinol

in gout patients otherwise eligible for the following Phase 3 studies:

Combination Study of Lesinurad in Allopurinol Standard of Care Inadequate Responders

(CLEAR #1)

–

randomized,

placebo-controlled

trial

of

lesinurad

added

to

allopurinol in

patients not reaching sUA target with allopurinol alone; North America

Combination Study of Lesinurad in Allopurinol Standard of Care Inadequate Responders

(CLEAR #2)

–

randomized,

placebo-controlled

trial

of

lesinurad

added

to

allopurinol in

patients not reaching sUA target with allopurinol alone; Global

Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors (LIGHT) –

randomized, placebo-controlled trial of lesinurad monotherapy in patients where febuxostat

and/or allopurinol

are

contraindicated

(due

to

intolerance,

drug

interactions,

co-morbidities,

etc); Global

Combination Treatment Study in Subjects with Tophaceous Gout Using Lesinurad and

Febuxostat (CRYSTAL)

–

randomized,

placebo-controlled

trial

of

lesinurad

in

combination

with febuxostat for the treatment of hyperuricemia in gout patients with tophi (resolution of

tophi is a key secondary endpoint); Global

Total patients planned for Phase

3

studies:

2000

–

2500

1

Exhibit 99.2

Long-term

Allopurinol

Safety

Study

Evaluating

Outcomes

in Gout

Patients

(LASSO

-

N.

America

&

Global)

Population:

–

Up

to

2500

pts

with

hyperuricemia

(sUA

>

8

mg/dL)

at

~300

centers

Design:

–

Provide therapy with allopurinol at the medically appropriate doses; monitor patients

for a minimum of 2 months prior to their being eligible for enrollment into Phase 3

program (~3 months or greater on allopurinol prior to Phase 3 baseline)

Objectives:

–

Generate patients for the Phase 3 program with well-documented inadequate

efficacy or intolerance

to

allopurinol

(ultimately

will

speed

up

enrollment

of

Phase 3

program)

2

Allopurinol prescribed at

labeled dose

Phase 3 -

Allopurinol SoC Inadequate Responders NA and ROW

Phase 3 -

Allopurinol SoC Inadequate Responders North America

Phase

3

–

Febuxostat

and

Allopurinol

Intolerant

Monotherapy

Combination

Study

of

LEsinurad

in

Allopurinol

Standard

of

Care

Inadequate

Responders

(CLEAR

-

N.

America)

Endpoints:

–

Primary: proportion of subjects with sUA level < 6.0 mg/dL after 6 months

–

Key Secondary: Assessment of gout flare rate, tophi resolution and quality of life measurements.

Screening

Period

Gout flare prophylaxis

3

RDEA594

200 mg + ALLO

RDEA594

Placebo + ALLO

3 weeks

1 week

Month 1 to Month 6 primary endpoint

Month 12 secondary endpoints

RDEA594

400 mg + ALLO

Combination Study of LEsinurad in Allopurinol Standard of

Care

Inadequate

Responders

(CLEAR

-

Global)

Endpoints:

–

Primary:

proportion

of

subjects

with

sUA

level

<

6.0

mg/dL

after

6

months

–

Key

Secondary:

Assessment

of

gout

flare

rate,

tophi

resolution

and

quality

of

life

measurements.

Screening

Period

Gout flare prophylaxis

4

RDEA594

200 mg + ALLO

RDEA594

Placebo + ALLO

3 weeks

1 week

Month 1 to Month 6 primary endpoint

Month 12 secondary endpoints

RDEA594

400 mg + ALLO

LesInurad

Monotherapy

in

Gout

Subjects

Intolerant

to

Xanthine

Oxidase

Inhibitors

(LIGHT

-

Global)

Endpoints:

–

Primary: Proportion of patients whose sUA levels are < 6.0 mg/dL after 6 months

5

Screening

Period

Gout flare prophylaxis

RDEA594

400 mg

RDEA594

Placebo

3 weeks

Month 1 to Month 6 primary endpoint

Placebo Patients Switched to Active at 6 months

RDEA594

400 mg

Combination

TReatment

StudY

in

Subjects

with

TophAeous

Gout

Using

LesInurad

and

Febuxostat

(CRYSTAL

-

Global)

Endpoints:

–

Primary –

proportion of subjects with sUA level < 5.0 mg/dL after 6 months

–

Key Secondary -

proportion of subjects with resolution of tophi at 6, 9 and 12 mos, gout flare

rate and quality of life measurements

RDEA594 200 mg +FBX 80 mg

Gout flare prophylaxis

6

RDEA594

Placebo +FBX 80 mg

RDEA594 400 mg +FBX 80 mg

FBX 80 mg

3 weeks

Month 1 to Month 6 primary endpoint

Month 12 secondary endpoints