Atara Biotherapeutics, Inc. ATRA announced initial ATA188 phase I safety results for patients with progressive multiple sclerosis (MS) at the 5th Congress of the European Academy of Neurology (EAN) in Oslo, Norway. The primary objective of the ongoing ATA188 phase I, dose-escalating clinical study is to evaluate safety and tolerability for patients with progressive MS.
ATA188 is a T-cell immunotherapy targeting Epstein-Barr virus (EBV) antigens, believed to be important for the potential treatment of MS. MS is a chronic autoimmune, inflammatory disease that affects axons in the central nervous system (CNS).
Shares of the company have plunged 42.2% year to date against the industry’s growth of 5.7%.
Initial safety results, as of Apr 8, 2019, showed that the first three ATA188 dose cohorts were well tolerated, with no dose-limiting toxicities and no ≥3 grade treatment-related, treatment-emergent adverse events. The key secondary endpoints of the phase I study include measures of clinical improvement, such as expanded disability status scale (EDSS), MRI imaging and other clinical activity measures. The study is ongoing and aims to identify a recommended phase II dose (RP2D). Further, a phase Ib extension period for this study, using the RP2D, is now planned following the completion of the open-label, dose-escalation period.
MS is a crowded market, with many companies already having drugs in their portfolio approved for this indication. Biogen, Inc. BIIB holds a strong position in this market with a wide range of products, including Avonex, Tysabri, Tecfidera and Plegridy. In March, swiss pharma giant Novartis AG NVS received FDA approval for its pipeline candidate Mayzent (siponimod), a next generation, selective sphingosine 1-phosphate receptor modulator, for the treatment of adults with relapsing forms of MS. Also Celgene’s CELG ozanimod, being developed for the treatment of people with relapsing forms of MS, is under review in the United States and Europe.
Atara currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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