AltruBio’s Neihulizumab Granted Fast Track Designation by the FDA for Steroid Refractory Acute Graft Versus Host Disease

REDWOOD CITY, Calif., March 08, 2021 (GLOBE NEWSWIRE) -- AltruBio Inc. (“AltruBio” or “the Company”), a clinical stage biotech company, announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for its immune checkpoint regulator, neihulizumab (AbGn-168H), for steroid refractory acute graft-versus-host disease (SR-aGVHD). Neihulizumab previously received orphan drug designation from the FDA for the treatment of aGVHD.

Dr. Judy Chou, president & CEO of AltruBio stated, “Receiving Fast Track designation for neihulizumab in steroid refractory acute GVHD is another important regulatory milestone for this clinical program. This designation validates the fact that although there are treatment options for this condition, significant unmet medical need remains. We believe neihulizumab has the potential to make a meaningful impact on the clinical outcome of patients, and we look forward to working closely with the FDA to further demonstrate this in our ongoing clinical trials.”

In order to be considered for Fast Track in an indication with approved therapies, a Fast Track drug must show the potential for advantage over available therapy. The Fast Track program is meant to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

Neihulizumab is an immune checkpoint regulator targeting PSGL-1, triggering the depletion of chronically activated T cells. This mechanism has been evaluated in four autoimmune and inflammatory diseases and has demonstrated clinical proof of concept and safety in more than 170 patients. It is currently being studied in a Phase 1b multi-dose trial in SR-aGVHD. In addition to the company sponsored SR-aGVHD trial, it is currently being studied for front line acute graft versus host disease (aGVHD) in an investigator sponsored trial.


AltruBio is a privately held biotechnology company headquartered in the San Francisco Bay Area that is focused on developing novel antibody therapeutics for the treatment of immunological diseases with high unmet medical needs. The company has leveraged its deep understanding of the role PSGL-1 plays as an immune checkpoint regulator protein to develop a platform for T-cell mediated immunological diseases. Its lead molecule, neihulizumab (AbGn-168H), an immune checkpoint agonist antibody targeting PSGL-1/CD162, is developed for intravenous administration and has achieved proof of mechanism in four autoimmune and inflammatory diseases, and is currently prioritized for further clinical development in steroid refractory acute graft-versus-host disease (SR-aGVHD). The company also has a number of next generation PSGL-1 antibodies at the preclinical stage. Its lead preclinical candidate, leiolizumab (AbGn-268), has demonstrated higher potency than AbGn-168H and is advancing toward IND for autoimmune and inflammatory disorders.

Note on Forward-Looking Statements
Statements made in this news release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as expects, believes, intends, and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as the Company's ability to raise additional capital, and risks related to the Company's ability to initiate, and enroll patients in, planned clinical trials. You should not place undue reliance on any forward-looking statements. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by law.


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Media Contact:
Darren Opland, PhD
LifeSci Communications