Study to Evaluate the Effect of FX006 on Synovial Inflammation in Patients With OA of the Knee

This is an open-label study assessing the effect of the administration of a single
intra-articular (IA) injection of FX006 32 mg on synovial volume in patients with
osteoarthritis (OA) of the knee. The study will be conducted in male and female patients who
are ≥ 40 years of age.

Eligible patients who provide written consent and meet all entry criteria will undergo
initial ultrasound examination and MRI with contrast of the index knee, and then receive a
single IA injection of FX006 administered to the index knee at Baseline/Day 1. Patients will
return to the clinic at Weeks 6 and 24 for an MRI with contrast of the index knee and other
assessments. Patients must also have a blood sample drawn for Estimated Glomerular Filtration
Rate (eGFR) testing within 30 days prior to the scheduled MRIs. In addition, a patient
questionnaire will be administered and adverse events (AEs) and concomitant medication
updates will be collected via telephone at Weeks 12 and 18.

Inclusion Criteria:

- Written consent to participate in the study

- Male or female ≥ 40 years of age

- Body mass index (BMI) ≤ 40 kg/m^2

- Ambulatory and in good general health

- Willing and able to comply with the study procedures and visit schedules and able to
follow verbal and written instructions

- Willing to abstain from use of protocol-restricted medications during the study

- Symptoms associated with OA of the index knee for ≥ 6 months prior to Screening
(patient self-report is acceptable)

- 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 based on X-ray performed during
Screening (centrally read)

Exclusion Criteria:

- Any inflammatory arthritis including reactive arthritis, rheumatoid arthritis,
psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory
bowel disease, gout or secondary OA from gout

- History of infection or crystal disease in the index knee joint

- Unstable index knee joint (such as a torn anterior cruciate ligament) within 12 months
of Screening

- Surgery or arthroscopy of the index knee within 12 months of Screening

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

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

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

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

- Any other IA drug/biologic in the index knee within 6 months of Screening or 5
half-lives (whichever is longer) (e.g., platelet rich plasma (PRP) injection, stem
cells, prolotherapy and amniotic fluid injection)

- Prior administration of FX006

- eGFR results <40 mL/minute

- Any contraindication to MRI Scanning (e.g., presence of certain ferromagnetic foreign
bodies or electronic devices including most cardiac pacemakers, claustrophobia)

- Known hypersensitivity to any form of radiographic contrast

- Females who are pregnant or nursing or plan to become pregnant during the study; men
who plan to conceive during the study