Atara Biotherapeutics‘ cell-based therapy ATA188 is safe and well-tolerated in people with progressive forms of multiple sclerosis (MS), and induces a sustained reduction in disability in a dose-dependent manner, findings from the first part of a Phase 1 clinical trial show.
ATA188 had an acceptable safety and tolerability profile across all four doses tested. But more people on higher doses experienced sustained decreases in disability, and researchers chose the 20 million dose (the second highest dose) for further testing in this trial’s second part.
Patient enrollment for this randomized, placebo-controlled part two is again underway at sites in the U.S. and Australia after a temporary pause in response to the COVID-19 pandemic, the company said in a press release.
The new data were presented at the 2020 European Academy of Neurology (EAN) Congress — which was held virtually due to the pandemic — in the poster “Phase 1 study of the safety and efficacy of ATA188, an off-the-shelf, allogeneic Epstein-Barr virus-targeted T-cell immunotherapy to treat progressive forms of multiple sclerosis” (EAN registration is needed to access the presentations).
Infection with the Epstein-Barr virus (EBV, a common form of the herpes virus) is increasingly seen as a possible cause of MS, leading B-cells to go rogue and produce antibodies that wrongly attack the protective myelin coating of nerve cells.
ATA188 is designed to help patients get rid of these damaging B-cells, by providing them with T-cells (immune cells with the ability to fight threats) that have been modified to eliminate EBV-infected cells.
The ongoing Phase 1a/1b trial (NCT03283826) is assessing the safety and effectiveness of ATA188 in a near equal mix of patients with either primary progressive MS (PPMS) or secondary progressive disease (SPMS).
It is being conducted in two parts. First, 25 patients were given one of four ATA188 doses — 5 million (5 x 106), 10 million (1 x 107), 20 million (2 x 107), or 40 million (4 x 107) cells — to determine the safest and most effective dose for future testing. The first three dose groups had six patients; in the fourth group, seven patients received the 40 million dose.
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