EBV T-Cell Treatment for MS: Trial Update

Research Update: ATA188 Phase 2 EMBOLD Study

Today, Atara Biotherapeutics provided an update on their Phase 2 randomised clinical trial, called the EMBOLD study, which is testing the safety and effectiveness of ATA188 in people living with non-active progressive forms of multiple sclerosis. 

ATA188 is a T-cell based therapy that aims to target Epstein-Barr virus (EBV) in people living with multiple sclerosis.  It is thought that this approach may provide clinical benefits for people living with MS, based on the results of previous smaller trials by multiple research groups.  For more information about how this treatment works, watch our video that discusses it and other potential EBV treatment avenues for multiple sclerosis here.

The update provided today was in the form of a press release and conference call.  It is important to note that no data has been presented to this point.  As a result, we are purely providing a short summary of what was announced, so that our community has access to the information as soon as possible.  As always, we will provide further details as soon as they become available.  We will be in a position to discuss the results in more depth and comment further after we’ve seen published data.

The original press release from Atara Biotherapeutics can be found here.

The key points to take from the update are as follows:

1. 1. 1. 1. This analysis included a review by the Independent Data and Safety Monitoring Committee (IDSMC).  It did not find any safety concerns with the treatment.

       

      1. 1. An interim analysis has been performed on the data that is currently available for the 6 month time-point of 34 participants.

       

      1. 1. It was thought from previous work that the 6 month results may be predictive of EDSS improvement at 12 months.  However, the data analysed from this Phase 2 trial was inconclusive.

       

      1. 1. It has been decided that the trial will continue on to the 12 month mark.  Results for all participants are expected in October 2023.

       

      1. 1. It has also been decided that an increase in the number of participants will not be required to obtain conclusive results from this trial.

       

So what does this all mean? 

Essentially, the most important message at this stage is that there have been no safety concerns identified in the initial part of this trial.  While there are no meaningful results to report at this stage, the trial has had good levels of recruitment and we can expect to hear the final 12 month analysis in October next year.