A Phase 1 Study to Evaluate ABC008 in Adult Patients with Inclusion Body Myositis
Abcuro is evaluating multiple increasing doses of ABC008 in a Phase 1 study in patients with inclusion body myositis, or IBM at several clinics in Australia. The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ABC008 administered as a single dose initially followed by multiple doses given every 8 weeks for 48 weeks. In addition, a small group of IBM patients will have PET/CT scans of the muscles with an exploratory imaging agent, [89Zr]Zr-Df-crefmirlimab to understand the effect ABC008 may have on diseased muscle.
A Phase 2/3 Study to Determine the Efficacy and Safety of ABC008 in Subjects with Inclusion Body Myositis
A Phase 2/3 blinded, randomized, placebo-controlled study evaluating ABC008 in inclusion body myositis, or IBM patients at several clinics globally. The purpose of this study is to evaluate the safety, tolerability and effect as measured by IBMFRS, the IBM functional rating scale, of one of two doses of ABC008 compared to a placebo given once every 8 weeks by subcutaneous (SC) injection for approximately 76 weeks. Initially, approximately 30 patients will be enrolled to evaluate the safety and tolerability of ABC008 at one of the two doses compared to placebo for 3 doses over 20 weeks. Once Part A is completed, Part B may begin and approximately 201 additional patients will be enrolled and dosed with the one of two doses of ABC008 or placebo every 8 weeks subcutaneously for 76 weeks.
A Phase 1/2 Study of ABC008 in Subjects with T-cell Large Granular Lymphocytic Leukemia (T-LGLL)
A Phase 1/2 open-label study of increasing doses of ABC008 is being conducted at several clinics in subjects with T-cell large granular lymphocytic leukemia, or T-LGLL. The purpose of the study is to understand the safety, tolerability, pharmacokinetics and pharmacodynamic effect as measured by changes in hemoglobin, neutrophils, and platelets in subjects with T-LGLL. Subjects will receive ABC008 every 8 weeks subcutaneously for approximately 48 weeks.
Expanded Access Policy
We understand that there may be circumstances under which patients or caregivers may request treatment with our investigative therapies before they have been approved by regulatory agencies. This is sometimes called “expanded access,” “right to try,” “compassionate use,” “early access,” or a “named patient program.” We use the term “expanded access” to capture all of these.
Participation in clinical trials is the most common way to access investigational therapies. Clinical trials ensure that the safety and efficacy of the investigational therapy are evaluated prior to submission for review and potential approval by regulatory authorities. Therefore, after careful consideration, Abcuro, as a clinical-stage company, has decided that the best way for patients to access our investigational therapies is through clinical trial participation. As a result, we will not offer expanded access at this time.
Any requests for expanded access of our investigational products may be referred to study investigators to determine a patient’s eligibility for one of our ongoing clinical studies.
Once we have completed and analyzed data from our registrational trials, (i.e., a clinical trial in which the results will be used to seek regulatory approval), we will evaluate the initiation of an expanded access program. Should changes be made to our expanded access policy, we will update this website.
Abcuro may revise this policy at any time as provided by the 21st Century Cures Act.