The Phase 1b trial (NCT03283826) follows promising safety and tolerability results from its open-label Phase 1a part, including a sustained lessening in disability among treated patients with primary progressive MS and secondary progressive MS.
This study’s placebo-controlled second part will assess ATA188’s safety, as well as its potential efficacy via measures of changes in patient disability, MRI imaging, and physical and cognitive function.
“The initiation of this [Phase 1b] study, including first-patient-enrolled, is an important step in further assessing the potential of ATA188 in progressive MS, a complex disease of high unmet medical need where disability continues to progress despite approved treatment options,” AJ Joshi, senior vice president and chief medical officer of Atara Biotherapeutics, said in a press release.
ATA188 is a cell-based therapy designed to counter the harmful effects of Epstein-Barr virus (EBV, a common type of herpes virus). Multiple avenues of research increasingly point toward EBV infection as a likely cause of MS. EBV can cause another class of immune cell, called B-cells, to produce antibodies against the myelin sheath of nerve cells.
Loss of myelin underlies the symptoms and progression of MS. By insulating nerve cells, myelin enables them to efficiently transmit the electrical impulses needed for tasks such as coordinating movement.
In the EBV hypothesis of MS, the body’s T-cells — which normally recognize and destroy foreign molecules like viruses — fail to clear infected B-cells. ATA188 provides patients with T-cells designed to selectively target EBV-infected B-cells.
The ongoing double-blind and randomized Phase 1b study will assess the safety and efficacy of ATA188 versus a placebo in up to 97 people. Its primary endpoints are the therapy’s safety and tolerability, as measured by the incidence of adverse events, and the change from baseline (study’s start) in immunoglobulin G (IgG) index, a measure of immune system health.
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