Atara Biotherapeutics has reported that its Phase II EMBOLD clinical trial of ATA188 for non-active progressive multiple sclerosis (PMS) failed to meet the primary endpoint.

The double-blind, open-label extension, placebo-controlled, randomised trial assessed the efficacy and safety of ATA188 in non-active PMS patients.

According to the initial assessment findings at 12 months, the trial failed to meet the primary endpoint of confirmed disability improvement (CDI) based on the expanded disability status scale (EDSS) versus placebo. 

The fluid and imaging biomarkers also did not offer any additional supportive data.

No new safety signals linked to the treatment were reported in the trial establishing its favourable safety profile so far.

To decide on the further steps for the programme, the company is currently assessing the totality of the trial findings. 

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By GlobalData

Atara president and CEO Pascal Touchon said: “We are surprised and deeply disappointed with the results of EMBOLD, particularly for the MS patient community, which is in urgent need of new treatment options. 

“We are further evaluating the EMBOLD data as we continue to believe in the critical role EBV plays in MS pathogenesis, however, we anticipate stopping the study as no treatment benefit was observed.”

“Looking ahead, we maintain our strong conviction in the potential of our pipeline reinforced by the first-ever regulatory approval of an allogeneic T-cell immunotherapy, EBVALLO, in Europe.” 

In due course, the company intends to cut down its expenditures on ATA188 and concentrate more of its resources on progressing its allogeneic CAR-T pipeline.

The company recently expanded its tab-cel collaboration with Pierre Fabre by carrying out biologics license application (BLA) transfer. 

Through the execution of these activities, the company expects to have a cash runway beyond the third quarter of 2025.