A Phase II/III Study of ABC008 to Determine Efficacy and Safety in IBM

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• 1. Any other form of myositis or myopathy other than IBM, e.g., metabolic or drug-induced myopathy, drug-induced myositis, anti-synthetase syndrome, polymyositis or dermatomyositis, cancer-associated myositis (myositis diagnosed within three years, either before or after), myositis in overlap with another autoimmune disease (e.g., systemic lupus, systemic sclerosis, rheumatoid arthritis), or muscular dystrophy; 2. Any condition, e.g., severe degenerative arthritis with limited range of motion, which precludes the ability to quantitate muscle strength or perform functional assessments (e.g., mTUG), in the Investigator’s opinion; 3. Presence of another autoimmune or autoinflammatory disease which, in the view of the Principal Investigator or MM, may impact the subject’s ability to perform study procedures such that it would confound clinical assessment. Examples include rheumatoid arthritis, psoriatic arthritis, axial spondyloarthropathy, inflammatory bowel disease, systemic lupus erythematosus. Subjects with Sjogren’s syndrome, T-cell large granular lymphocyte leukemia (T-LGLL), or well-controlled thyroid disease are permitted 4. Receipt of any of the following treatments within the following time frames before Screening (or as otherwise specified): a. Intravenous or intramuscular corticosteroids: four weeks; b. Oral prednisone (or prednisone equivalent) >7.5 mg/day at Screening; c. Use of nonbiologic immunosuppressants (e.g., cyclosporine, mycophenolate mofetil or sodium, azathioprine, methotrexate, sirolimus, Janus kinase inhibitors): 12 weeks; d. Intra-articular therapies, such as corticosteroids or hyaluronic acid preparations: four weeks; e. Intravenous, intramuscular, or SC immunoglobulin (IVIG, IMIG, or SCIG): 12 weeks; f. Cytokine, integrin, or activin antagonists or selective co-stimulation modulators, including but not limited to, interleukin (IL)-1, IL-6, IL-17, IL-12/23, IL-23, interferon, integrin, and tumor necrosis factor α antagonists, abatacept, bimagrumab: 12 weeks; g. Cell-depleting or modulating therapies (e.g., alemtuzumab, antithymocyte globulin, atacicept, belimumab, obinutuzumab, ocrelizumab, ofatumumab, rituximab, siplizumab): 12 months; h. Use of chemotherapeutic regimens or other cytotoxic therapies, e.g., cyclophosphamide, doxorubicin or hydroxyrubicin, vincristine, and prednisone; purine analogs, alkylating agents: 24 weeks; i. Other immunomodulatory biologics: 12 weeks or five half-lives, whichever is longer; j. Transfusion with blood, packed red blood cells, or platelets or treatment with plasmapheresis or plasma exchange: six weeks; k. Anabolic steroids: four weeks; l. Growth hormone: four weeks; m. Physiologic supplementation with testosterone permitted provided dose stable for four weeks before Screening and expected to stay stable during the study; n. Therapies associated with neuromuscular side effects including antimalarial drugs (e.g., chloroquine, hydroxychloroquine), colchicine, cholesterol-lowering drugs (e.g., statins) except if on stable dose for at least 12 weeks, and without impact on assessment of IBM progression; 5. Initiation of an exercise or a physical therapy regimen within four weeks of Screening. Any exercise or physical therapy regimen initiated prior to the Screening Visit must have been stable for at least four weeks prior to Screening; Please refer to protocol for a complete list of the exclusion criteria