Atara Bio (ATRA) has revealed data from the first part of the ongoing Phase 1 study of ATA188 for the treatment of progressive forms of multiple sclerosis (MS). ATA188 is an off-the-shelf, allogeneic EBV-specific T-cell immunotherapy.
These data demonstrate that ATA188 was well-tolerated across all four dose cohorts; patients who achieved sustained disability improvements at any timepoint maintained it at all future timepoints and a higher proportion of patients showed sustained disability improvements (SDI) with increasing dose.
“It is very encouraging to see that patients receiving ATA188 who achieved sustained disability improvement at any time point maintained it at all future time points and tended to also show improvements in fatigue and physical function at 12 months,” said the company’s Jakob Dupont.
“These results together with a favorable safety profile highlight the potential of ATA188 for patients with progressive MS and reinforce our excitement around advancing the randomized placebo-controlled portion of the study which is currently enrolling” he added.
All patients in cohorts 1-4 of this Phase 1 study showing SDI at six months, maintained improvement through 12 months. Additionally, a dose-related increase in the number of patients with SDI at 12 months was observed (42% in Cohorts 3 and 4 vs 17% in Cohorts 1 and 2).
Data from the open-label extension (OLE) with redosing at 12 months show that all three patients that achieved SDI at 12 months maintained SDI at 15 months with one patient maintaining SDI at 18 months and another at 24 months.
The study found that ATA188 was well-tolerated, and the safety profile remained consistent with previously reported data. (See ATRA stock analysis on TipRanks)
Shares in Atara rose 5% in Friday’s trading, bringing the stock’s year-to-date loss to 9%. Nonetheless, analysts have a bullish Strong Buy consensus on ATRA’s outlook with the average price target indicating shares can more than double from current levels.
Mizuho Securities analyst Salim Syed estimates ATA188 can do $3.5Bn in unadjusted peak sales, adding that a drug like ATA188 may actually show better results as data matures (i.e. beyond month 12). He notes that crucially patients who achieve sustained disability improvement haven’t reverted, but are rather maintaining effect.
Meanwhile Canaccord Genuity analyst John Newman has a buy rating and $70 price target on the stock, saying: “We continue to expect strong efficacy for ATA-188, and positive results from the randomized trial in progressive multiple sclerosis.”
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