Sep 10, 2013
Apitope Technology Ltd. announced that in a phase I study in 42 people with relapsing MS, the experimental treatment ATX-MS-1467 reduced disease activity on MRI scans when given intradermally (within the skin). (Apitope press release, September 3, 2013). Details about its safety and tolerability were not announced.
Apitope was the first in a series of partnerships between the National MS Society’s drug development arm, Fast Forward, and early stage biotechnology companies. The company successfully leveraged this support by entering into a research, development and license agreement with Merck Serono for development and commercialization ATX-MS-1467.
Background: Multiple sclerosis involves immune attacks launched on the brain and spinal cord. Apitope has developed a proprietary approach to identify pieces of proteins, called “peptides” derived from human antigenic proteins that might be able to reinstate “immune tolerance” – in effect, train immune cells to ignore target tissues – to suppress such an attack. ATX-MS-1467 is a mixture of four such peptides. An earlier clinical trial in 6 people with secondary-progressive MS indicated that the drug was well tolerated with early evidence of potential efficacy.
The Study: The current study recruited 42 people with relapsing MS (relapsing-remitting, and secondary-progressive with relapses). Participants were randomly assigned to receive ATX-MS-1467 delivered via injection into layers of skin (intradermally) or subcutaneously (under the skin), every two weeks, for a total of nine doses. Participants were then followed for 22 weeks. (For further details, see the study’s listing on clinicaltrials.gov.
The press release reports a significant decrease in disease activity seen on MRI scans in the group treated by intradermal injection, but not in those treated with subcutaneous (under the skin) injection.
Comment: The complete results of this study and further, phase II and phase III studies will help to determine whether ATX-MS-1467 has potential to be developed into a safe and effective treatment for people with MS. These results are an example of how, by connecting people, ideas, and resources, the Society is helping promising treatments to break through barriers, move through the pipeline, and enter clinical trials -- faster.
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