Study of FX005 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

The objectives of the study are to assess FX005, as compared to placebo control, for:

• Safety and tolerability
• Analgesic effect
• Pharmacokinetics

Analgesic effect will be assessed using the Western Ontario & McMaster University Osteoarthritis Index (WOMAC), the Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire, and patient and clinical observer global assessments.

Inclusion criteria

• Male or female ≥40 years of age
• Diagnosis of unilateral or bilateral osteoarthritis of the knee for at least 6 months; confirmation of osteoarthritis according to American College of Rheumatology Criteria (clinical and radiological)
• Kellgren-Lawrence grades II or III
• Mean score for the WOMAC A subscale (pain) between 2.0 and 3.5 for the index knee
• Score of 2-3 for the WOMAC A1 score (pain on walking) for the index knee
• Body mass index ≤ 40 kg/m2
• Willingness to abstain from use of restricted medications during the study
• Willingness and ability to comply with the study procedures and visit schedule

Exclusion criteria

• Kellgren-Lawrence Grade 0, I or IV radiographic stage of the index knee
• Clinically apparent tense effusion in index knee
• Presence of surgical hardware or other foreign body in the index knee
• Clinical signs and symptoms of active knee infection or crystal disease
• Intra-articular corticosteroid within 3 months of Screening
• Intra-articular hyaluronic acid within 6 months of Screening
• Other intra-articular therapy within 3 months of Screening
• Prior arthroscopic or open surgery of the index knee within 12 months of Screening
• Planned/anticipated surgery of the index knee during the study period
• History of malignancy or other serious, non-malignant, significant, acute or chronic medical (e.g.. uncontrolled diabetes) or active psychiatric illness
• Skin breakdown at the knee where the injection would take place
• Women who are pregnant, nursing or likely to become pregnant during the time of the study
• Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year) not using effective contraception