A Study to Investigate the Effectiveness, Safety, and Tolerability of MAG200 Solution for Intra-articular Injection Compared With Placebo in Participants Aged 35 to 75 Years of Age With Symptomatic Osteoarthritis of the Knee.

Inclusion criteria

• Males and females aged ≥ 35 years to ≤ 75 years inclusive.
• BMI ≥ 19.0 to ≤ 35.0 kg/m2.
• Documented clinical diagnosis of OA of the study knee.
• Documented radiological grading of Grade 2 or Grade 3 medial and/or lateral compartment OA of the study knee.
• Documented radiological grading of OARSI JSN 1-2 of the medial and/or lateral compartment of the study knee.
• Primary OA treatment of the study knee already attempted within the last 12 months, defined as:

• Prescribed analgesia/anti-inflammatory medication where appropriate, AND
• an attempted exercise program prescribed by a physical therapist (e.g., physiotherapist, osteopath) or medical practitioner for at least 8 weeks, AND
• weight management, where appropriate.
• Moderate to severe knee specific activity related pain score on the NRS for Pain over the past week.
• Moderate to severe knee specific functional limitation on KOOS-PS.
• Less than 5 degrees varus or valgus knee deformity of the study knee relative to neutral alignment.

Exclusion criteria

• Any of the following relating to the study knee:

• Radiological evidence of KL Grade 4 OA (involving medial, lateral and/or patellofemoral compartment) or OARSI JSN 3.
• History of recurrent mechanical instability and / or locking.
• Joint surgery or significant knee injury within 12 months prior to Day 1.
• Metal in-situ resulting in metal artefact which impacts/prevents MRI assessment.
• MRI confirmed:

i. Generalised full thickness chondral loss involving tibial and/or femoral weight bearing surfaces ii. Total meniscectomy iii. Complete posterior meniscal root tear iv. Subchondral insufficiency fracture v. Osteonecrosis vi. Malignant bone marrow infiltration vii. Solid tumors viii. Traumatic fracture/bone contusion ix. Knee pathology requiring orthopaedic assessment/intervention (e.g., significant loose body)

• Other causes of the knee symptoms unrelated to knee OA.
• Significant and debilitating OA in the non-study knee.