The purpose of this study is to determine the safety, tolerability, and activity of ICM-203, a recombinant adeno-associated viral (AAV) vector that expresses a therapeutic gene that promotes cartilage formation, reduces joint inflammation and pain, as well as improves joint physical function, by injecting escalating doses of ICM-203 into the knee of subjects with mild to moderate knee osteoarthritis (OA).
Approximately 6 to 18 subjects will be enrolled into 3 successive dose-escalating groups in a 3+3 study design, whereby 3 study subjects in each group will be dosed sequentially with ICM-203 and 3 additional subjects will be dosed at the same dose level if a dose limiting toxicity (DLT) occurs in any of the first 3 subjects.
Body mass index (BMI) of 18.0 to 40.0 kg/m2, inclusive, at the time of screening.
Kellgren-Lawrence grade 2 or grade 3 OA of target knee.
Target knee pain between 4 and 9, inclusive, on an NRS ranging from 0 (no pain) to 10 (worst pain imaginable), at the time of screening.
KOOS function in daily living score >25, a measure of knee function ranging from 0 (extreme problems) to 100 (no problems), at the time of screening .
History of rheumatoid arthritis, psoriatic arthritis, gout, pseudogout, autoimmune OA, chondrocalcinosis, hemochromatosis, villonodular synovitis, and synovial chondromatosis or other disorder that in the opinion of the Investigator could cause inflammation of the knee.
Injection of steroid, hyaluronate or other agent, into the target knee less than 90 days prior to day 1.
Major injury to the target knee, such as torn ligament or severe sprain, within 12 months of screening.
Disability so severe that the subject cannot comply with the study requirements, including knee symptoms that result in significant difficulty or inability to walk.
Sequential
ICM-203
GeneticIntra-articular injection
Treatment-Emergent Adverse Events (TEAEs)
Incidence and Severity of Treatment-Emergent Adverse Events following administration of study drug
Knee pain
Evaluation of change from baseline in knee pain as measured using a Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable)
Knee function
Evaluation of change from baseline in knee function as measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) function in daily living subscale ranging from 0 (extreme problems) to 100 (no problems)
Analgesic use
Evaluation of change from baseline in in use of analgesics, such as acetaminophen and NSAIDs
Humoral response to AAV5.2 capsid
Evaluation of change from baseline in neutralizing antibody titers against AAV5.2 in serum
Cellular immune response to AAV5.2 capsid
Evaluation of change from baseline in T-cell responses to AAV5.2 capsid
Systemic biodistribution of ICM-203
Evaluation of presence of ICM-203 in peripheral blood after administration of study drug
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