Atara Biotherapeutics Inc (NASDAQ:ATRA) announced on Wednesday last week that it signed up the first patient in its Phase 1b study of ATA188, an Allogeneic T-cell Therapy aimed at treating multiple sclerosis.
ATA188 is an EBV-specific T-cell therapy that has been designed to target progressive multiple sclerosis. The Phase 1b clinical study will be conducted as a double-blind, randomized placebo-controlled evaluation that will aim to determine the treatment’s safety and efficacy. The company was pleased to announce that it enrolled its first patient in the study.
The clinical study will also feature key biomarkers and measures designed to monitor the patients’ function. They will also collect data from standard disability measures, cerebrospinal fluid, blood biomarkers, and cognition and outpatient ambulatory activity; it will include MRI imaging.
“We are thrilled at the investigator and patient interest in our randomized placebo-controlled Phase 1b study assessing the efficacy and safety of ATA188,” stated Atara Biotherapeutics’ Chief Medical Officer, AJ Joshi.
Mr. Joshi also added that the study’s launch and the enrollment of the first patient marks an important milestone for the company. It is particularly an important step in evaluating ATA188’s potential as a treatment for combatting aggressive multiple sclerosis. The Chief Medical Officer also noted that the disease has a lot of unmet medical needs, especially as the disability continues to take root.
ATA188‘s Phase 1a study demonstrated significant positive findings in its ability to provide improvements against the disability caused by MS. The company’s researchers are confident in the treatment’s ability to deliver better results in the Phase 1B clinical study.
The randomized, placebo-controlled study will be conducted in multiple clinical sites in the U.S and Australia. Atara researchers will evaluate the primary endpoints at 12 months for the cohort 3-dose treated with a placebo. The patients will then be transferred to an active treatment regimen. All the patients that will have signed up for the clinical study will also get a chance to be part of an open-label extension that will run for an extra 3-years after they go through treatment or the first two years.