- Atara Biotherapeutics Inc ATRA completed the planned Interim Analysis of the ATA188 Phase 2 study (EMBOLD) in progressive multiple sclerosis patients.
- The analysis’ primary focus was on expanded disability status scale (EDSS) improvement at six months and overall safety, and also included evaluation of EDSS beyond six months for patients.
- The analysis was also designed to assess if a sample size increase was needed. It was planned to occur before enrolling patient 80 to enable an increased sample size if needed.
- EDSS improvement appeared to be predictive of improvement at 12 months.
- Also See: Read Why Did HC Wainwright Cut Price Target On Atara Biotherapeutics.
- There was no sufficient dataset to draw conclusions about the predictive value of six months EDSS improvements for 12 months.
- The safety monitoring committee believes the six-month interim endpoint may be an inaccurate measure. It recommended continuing the study without sample size adjustment until the final analysis.
- The final read-out of the study’s primary endpoint of confirmed EDSS improvement at 12 months is planned for October 2023.
- Price Action: ATRA shares are down 52% at $4.16 during the premarket session on the last check Wednesday.
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