Abata Therapeutics Receives FDA Fast Track Designation for Progressive Multiple Sclerosis Treatment

Abata Therapeutics recently announced the US FDA has granted Fast Track designation for ABA-101 for the treatment of patients with progressive multiple sclerosis (MS). The FDA recently cleared ABA-101’s Investigational New Drug (IND) application, and initiation of a first-in-human (FIH) Phase 1 study is imminent.

“There are no effective treatments for progressive MS, and rapidly advancing new therapies is critical for patients and their families. We are very pleased that the FDA granted us Fast Track designation as it will enable us to expedite our efforts to bring ABA-101 to patients,” said Samantha Singer, MS, MBA, President and Chief Executive Officer of Abata. “We are focused on initiating our Phase 1 study this year in patients and evaluating the potential impact of this important new therapy.”

The FDA grants Fast Track designation to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, with the ultimate goal of getting important new drugs to patients earlier. A drug that receives Fast Track designation may be eligible for more frequent meetings and communications with the FDA and rolling review of any application for marketing approval, which may lead to earlier drug approval and access for patients. A drug receiving Fast Track designation also may be eligible for Accelerated Approval and Priority Review if relevant criteria are met.

ABA-101 is Abata’s autologous Treg therapy in development for the treatment of progressive multiple sclerosis. It was specifically designed for MS patients with progressive disease who have imaging evidence of ongoing inflammatory tissue injury and are HLA-DRB1*15:01 positive – an estimated patient group of about 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 was designed to offer a strong safety profile and a highly localized anti-inflammatory effect at the site of disease. In in vivo preclinical studies, ABA-101 was well-tolerated and demonstrated antigen-dependent Treg functionality, anti-inflammatory cytokine production, suppression of the production of inflammatory cytokines and therapeutic effect.

Abata Therapeutics is dedicated to transforming 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 create engineered 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 study in 2024, and its second program in type 1 diabetes is in IND-enabling studies. Both indications are tissue-specific autoimmune diseases with substantial unmet need, supporting a strong rationale for Abata’s Treg approach. The company was launched in 2021 by Third Rock Ventures, and today is supported by a diverse syndicate 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, MA. For more information, visit  abatatx.com.