Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee

This was a double-blind, randomized, parallel group, dose-ranging, single-dose study. The
study was conducted in male and female patients ≥40 years of age with OA of the knee.

Approximately 300 patients with OA of the knee were randomized, using a centralized
randomization procedure, to 1 of 3 treatment groups (1:1:1) and treated with a single IA
injection of:

- 16 mg FX006,

- 32 mg FX006, or

- normal saline (placebo).

Each patient was evaluated for a total of 24 weeks following a single IA injection. Following
screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 [Baseline],
Weeks 4, 8, 12, 16, 20, and 24).

The study was expected to enroll over approximately 6 to 7 months.

Main Inclusion Criteria:

- Willingness and ability to comply with the study procedures and visit schedules and
ability to follow verbal and written instructions

- Male or female >=40 years of age

- Has documented diagnosis of OA of the index knee made at least 6 months prior to
Screening

- Currently meets American College of Rheumatology (ACR) Criteria (clinical and
radiological) for OA

- Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee per Screening X-ray

- Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)

- Body mass index (BMI) ≤ 40 kg/m2

- Willingness to abstain from use of restricted medications

Main Exclusion Criteria:

- Ipsilateral hip OA

- Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic
conditions which could interfere with the evaluation of the index knee

- History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing
spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or
amyloidosis

- History of arthritides due to crystals (e.g., gout, pseudogout)

- History or clinical signs and symptoms of infection in the index joint

- Knee pain that is not clinically attributable to OA of the knee (e.g., radicular low
back pain and hip pain that is referred to the knee that could cause
misclassification)

- Pain in any other area of the lower extremities or back that is equal to or greater
than the index knee pain

- IA corticosteroid (investigational or marketed) in any joint within 3 months of
Screening

- IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of
Screening

- Intramuscular (IM) corticosteroids (investigational or marketed) within 3 months of
Screening

- Oral corticosteroids (investigational or marketed) within 1 month of Screening

- Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2
weeks of Screening

- Any other IA investigational drug/biologic within 6 months of Screening

- Prior use of FX006

- Women of child-bearing potential not using effective contraception or who are pregnant
or nursing