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Preclinical development and first-in-human study of ATX-MS-1467 for immunotherapy of MS
Heather B Streeter1, Rachel Rigden1, Keith F Martin1
1Apitope Technology Bristol Ltd. (H.B.S., R.R., K.F.M., D.C.W.), Bristol UK; School of Cellular and Molecular Medicine (H.B.S., D.C.W.) and School of Clinical Sciences (N.J.S.), University of Bristol, UK; and Southmead Hospital (N.J.S.), Bristol, UK.
Objective:
The study was designed to test the efficacy of ATX-MS-1467 in a relevant preclinical model and to assess its safety for the treatment of patients with secondary progressive multiple sclerosis (SPMS).
Methods:
ATX-MS-1467 was tested for its ability to suppress experimental autoimmune encephalomyelitis (EAE) in the (Ob x DR2)F1 mouse both before and after disease onset. Safety was assessed by clinical assessment, MRI analysis, and the measurement of immune responses to self- and nonself-antigens in patients with SPMS.
Results:
ATX-MS-1467 displayed a dose-dependent inhibition of EAE and was more effective than glatiramer acetate in the treatment of ongoing disease in humanized mice. A phase 1 open-label dose-escalating study demonstrated that ATX-MS-1467 was safe and well-tolerated in a group of 6 patients with SPMS, up to a dose of 800 µg.
Conclusions:
The results of this study support further development of ATX-MS-1467 in a clinical trial powered to investigate the immunologic and clinical benefits of treatment in relapsing-remitting MS.
Classification Of Evidence:
This study provides Class IV evidence that ATX-MS-1467 is safe and tolerated in a group of 6 patients with SPMS.
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