Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis

This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study in
patients with hip OA. Approximately 440 patients will be randomized to one of two treatment
groups (1:1) and treated with a single IA injection of either 32 mg FX006 or normal saline.

FX006 or saline placebo will be administered as a single IA injection with a 12-week
follow-up period in the double-blind phase.

Patients eligible for the second injection in the open-label phase at Week 12 will receive an
open-label injection of FX006 at Week 12 and return for follow-up visits at Weeks 16, 20, and
24. These patients will complete the study at Week 24.

Patients who are not clinically indicated for a second injection at Week 12 will return to
the clinic at Weeks 16, 20, and 24 and will receive an open-label injection of FX006 at the
first evaluation where the patient has been determined to meet all criteria. Patients will
then return for follow-up visits every 4 weeks for 12 weeks post second injection and will
complete the study 12 weeks post second injection (e.g., Week 24, 28, 32, or 36 depending on
when the patient receives the open-label injection).

Patients who are not eligible for a second injection after evaluation at Weeks 12, 16, 20,
and 24 will complete the study at the Week 24 visit and complete the End of Study (EOS)
assessments.

Inclusion Criteria:

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

- Patients 40 to 80 years of age, inclusive, on the day of randomization (Day 1)

- Body Mass Index (BMI) ≤ 40 kg/m2

- Symptoms associated with OA of the index hip for ≥ 3 months prior to Screening visit

- Currently meet the American College of Radiology (ACR) Criteria (clinical and
radiological) for OA of the index hip

- Kellgren-Lawrence (KL) Grade 2 or 3 in the index hip as confirmed by X-ray during
Screening visit (centrally read)

- Qualifying mean score on the WOMAC A and C (0-10 NRS scale)

- Agree to maintain the similar activity level throughout the study

- Willingness to abstain from use of restricted medications

Exclusion Criteria:

- Patients who cannot washout of prohibited medications

- Diagnosed as secondary OA in the index hip including but not limited to articular
fracture, major dysplasia or congenital abnormality, osteochondritis dissecans,
acromegaly, ochronosis, hemochromatosis, Wilson's disease, or primary
osteochondromatosis, etc.

- Ipsilateral chronic knee pain

- Sciatica

- Atrophic osteoarthritis, femoral head necrosis and/or collapse, or subchondral bone
insufficiency fracture in the index hip joint determined via central reading

- Current or history of infection in the index hip (e.g. osteomyelitis) or current skin
infection at injection site

- Trauma or surgeries (e.g., arthroscopy, knee surgery) of lower limbs within 52 weeks
with sequelae, etc.

- History or current evidence of reactive arthritis, rheumatoid arthritis, psoriatic
arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel
disease, systemic lupus erythematosus or other autoimmune diseases

- Any planned surgeries in the lower limbs during the study period, or any other surgery
during the study period that would require use of a restricted medication

- Presence of surgical hardware or other foreign body in the index hip

- Planned/anticipated surgery of the index hip or any other surgery that would require
use of a restricted medication during the study period

- IA corticosteroid of any joint within 3 months of Screening visit (investigational or
marketed, including FX006)

- IA treatment of index hip with any of the following agents within 6 months of
Screening: any biologic agent or hyaluronic acid (investigational or marketed)

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

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

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

- Planned or expected changes to lifestyle with regard to physical activity, physical
therapy, acupuncture, transcutaneous electrical nerve stimulation (TENS), or bracing
within 1 month prior to Screening and changes throughout the duration of the study

- Women of child-bearing potential (not surgically sterile or post-menopausal for at
least 1 year as documented in medical history) not using a highly effective method or
who are pregnant or nursing