Elixiron Immunotherapeutics, a clinical stage biotech company, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its interferon-gamma-neutralizing human antibody, EI‑001 for the treatment of hemophagocytic lymphohistiocytosis (HLH).
SAN FRANCISCO, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Elixiron Immunotherapeutics, a clinical stage biotech company, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its interferon-gamma-neutralizing human antibody, EI‑001 for the treatment of hemophagocytic lymphohistiocytosis (HLH).
“HLH is a life-threatening disease in children and adults requiring aggressive intervention to control the symptoms that are driven in large part by aberrant or excessive interferon-gamma production,” said Hung-Kai Kevin Chen, Chief Executive Officer of Elixiron. “The Orphan Drug Designation will definitely accelerate our ability to bring EI‑001 to market sooner rather than later, to offer patients what we feel will be a better treatment than currently-available options.”
Orphan Drug Designation serves to support drug candidates in development for underserved patient populations or rare disorders that affect fewer than 200,000 people in the U.S., providing for various incentives including tax credits for eligible clinical trials, waiver of application fees, and market exclusivity for seven years upon FDA approval.
About Hemophagocytic Lymphohistiocytosis (HLH)
HLH is a rare, life-threatening hyper-inflammatory disease characterized by marked immune activation and uncontrolled hemophagocytosis driven by activated macrophages. Among the cytokines elevated in HLH, interferon-gamma was found to be the most sensitive and early indicator of disease activity, and a critical pathogenic role of interferon-gamma has been confirmed in animal models as well as in clinical trials in which interferon-gamma-neutralizing antibody improved disease symptoms.
About EI-001
EI‑001 is an interferon-gamma-neutralizing human antibody that was isolated as an autoantibody from a human subject by single B cell antibody cloning. Interferon-gamma is a major driver of pathology in HLH and is thought to be an important target in some other inflammatory or immunological disorders including vitiligo. EI-001 is currently in a phase I safety trial (NCT04994912).
About Elixiron Immunotherapeutics
Elixiron Immunotherapeutics is developing innovative immunotherapies to address unmet needs in rare and immunological diseases. Besides EI‑001, Elixiron has an orally-administered, small molecule inhibitor of the colony stimulating factor‑1 receptor (CSF‑1R) kinase, EI-1071, that has successfully completed phase I development. EI‑1071 is being developed for the treatment of Alzheimer’s disease with funding support in part from the Alzheimer’s Association Part the Cloud program. For more information, visit elixiron.com and follow the company on LinkedIn.
Contact
Yuri Zhao
Email: media@elixiron.com
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