WATERTOWN, Mass., Aug. 22, 2024 (GLOBE NEWSWIRE) — Abata Therapeutics, a company focused on changing lives with Treg therapies for severe autoimmune and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ABA-101 for the treatment of patients with progressive multiple sclerosis (MS). The FDA recently approved the Investigational New Drug (IND) application for ABA-101, and the initiation of a first-in-human (FIH) Phase 1 trial is imminent.

“There is no effective treatment for progressive MS, and the rapid development of new therapies is critical for patients and their families. We are very pleased that the FDA has granted us Fast Track designation as it will allow us to accelerate our efforts to bring ABA-101 to patients,” said Samantha Singer, MS, MBA, President and CEO of Abata. “We are focused on starting our Phase 1 trial in patients this year and evaluating the potential impact of this important new therapy.”

The FDA grants Fast Track designation to facilitate the development and review of drugs to treat serious diseases and meet unmet medical needs, with the ultimate goal of making important new drugs available to patients sooner. A drug that receives Fast Track designation may be eligible for more frequent meetings and communications with the FDA and ongoing review of all marketing authorization applications, which may lead to earlier drug approval and availability to patients. A drug that receives Fast Track designation may also be eligible for accelerated approval and priority review if relevant criteria are met.

About ABA-101 and progressive multiple sclerosis
ABA-101 is Abata’s autologous Treg therapy being developed to treat progressive multiple sclerosis. It is specifically designed for MS patients with progressive disease who have imaging evidence of progressive inflammatory tissue damage and who are HLA-DRB1*15:01 positive – an estimated patient population of approximately 45,000 in the U.S. today. ABA-101 is created by engineering a patient’s own Tregs to express a T cell receptor (TCR) that specifically recognizes immunogenic myelin fragments in the CNS. This approach is designed to provide a strong safety profile and highly localized anti-inflammatory activity at the site of disease. In in vivo In preclinical studies, ABA-101 was well tolerated and demonstrated antigen-dependent Treg functionality, production of anti-inflammatory cytokines, suppression of inflammatory cytokine production, and therapeutic activity.

About Abata Therapeutics
Abata Therapeutics is committed to changing lives with Treg therapies for severe autoimmune and inflammatory diseases. Founded by pioneers in Treg biology, TCR and antigen discovery, disease pathogenesis, and molecular and imaging biomarkers, Abata has developed a differentiated product engine to develop Treg cell therapies that are tissue-specific, robust, and durable. Abata’s lead program in progressive MS is on track to initiate a Phase 1 trial in 2024, and its second program in type 1 diabetes is in IND-enabled studies. Both indications are tissue-specific autoimmune diseases with significant unmet need, providing a strong rationale for Abata’s Treg approach. The company was founded in 2021 by Third Rock Ventures and is now backed by a diverse consortium of investors including Lightspeed Venture Partners, Biogen, Bristol Myers Squibb, ElevateBio, Eurofarma, Invus, Samsara BioCapital and T1D Fund (formerly JDRF T1D Fund). Abata is based in Watertown, Massachusetts. Please visit abatatx.com or follow us on X (formerly known as Twitter) or LinkedIn for more information.

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Cory Tromblee
Science PR
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Precision AQ
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