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AltruBio Announces Completion of Enrollment in Phase 1 Clinical Study of Neihulizumab (ALTB-168) in Patients with Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)

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AltruBio Announces Completion of Enrollment in Phase 1 Clinical Study of Neihulizumab (ALTB-168) in Patients with Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)

AltruBio Announces Completion of Enrollment in Phase 1 Clinical Study of Neihulizumab (ALTB-168) in Patients with Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)

SAN FRANCISCO, May 12, 2022 (GLOBE NEWSWIRE) -- AltruBio Inc. (“AltruBio” or “the Company”), a clinical stage biotech company dedicated to the development of novel therapeutics for the treatment of immunological diseases with high unmet medical needs, today announced that enrollment has been completed for the Phase 1 clinical study of neihulizumab (ALTB-168) in patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD) or treatment-refractory acute graft-versus-host disease with 24 patients enrolled. This study is designed to establish pharmacokinetics, pharmacodynamics, safety and efficacy in patients with SR-aGVHD.

“We are pleased with the progress of ALTB-168, which has been clinically validated across multiple inflammatory conditions including psoriasis, psoriatic arthritis, ulcerative colitis, and acute GVHD,” said Judy Chou, Ph.D., President and Chief Executive Officer of AltruBio. “Despite headwinds and challenges brought on by the COVID-19 pandemic, we completed enrollment ahead of schedule, a testament to our ability as a company to manage challenging clinical trials. Furthermore, we see rapid enrollment of this study as a measure of confidence from physicians and their belief in the potential of ALTB-168 as a safer and more effective treatment for GVHD. We look forward to sharing efficacy and safety data from the Phase 1 study in the coming months.”

Jesse Hall, M.D., Chief Medical Officer of AltruBio added, “ALTB-168 demonstrated improved patient outcomes in patients with aGVHD, with benefits observed across all organs involved, including in difficult to treat GI disease. With over 190 patients dosed in four different indications, ALTB-168 has been well tolerated and has demonstrate the potential for durable response outcomes. We are encouraged by ALTB-168’s first-in-class mechanism of action, and look forward to rapidly advancing our next generation, ALTB-268, antibody to the clinic. ALTB-268 is a more potent antibody and will allow for subcutaneous administration and is intended to target a broad range of chronic autoimmune diseases. We expect to file an IND in the second half of 2022.”

ABOUT ALTB-168
Neihulizumab (ALTB-168) is an immune checkpoint agonist antibody that regulates T cell homeostasis. The unique mechanism of action provides a natural regulation of T cell homeostasis that induces cell death preferentially in late-stage activated T cells without affecting resting T cells and early-activated T cells. Because pathogenic T cells underlying the inflammatory conditions are usually in late-stage activated state, eliminating this population of cells can potentially result in controlling autoimmune inflammation of T cell associated diseases, such as GvHD.

ALTB-168 is being evaluated in a Phase 1 study (NCT03327857) to establish the pharmacokinetics, pharmacodynamics, safety and efficacy profiles in patients with steroid-refractory or treatment refractory acute graft-versus-host disease (SR/TR-aGVHD).

ABOUT ALTRUBIO INC.
AltruBio is a privately held biotechnology company headquartered in San Francisco that is focused on developing novel 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 first-generation molecule, neihulizumab (ALTB-168), an immune checkpoint agonist antibody targeting PSGL-1/CD162 has achieved proof of mechanism in four autoimmune and inflammatory diseases including ulcerative colitis, steroid refractory acute graft-versus-host disease (SR-aGVHD), psoriatic arthritis, and psoriasis. The next-generation PSGL-1 agonist ALTB-268 is a tetravalent version of ALTB-168 and has demonstrated high potency via the same mechanism, which makes it suitable for subcutaneous administration in the proven indications and is advancing toward IND for multiple 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.

Contacts

AltruBio Inc:
+1-415-655-6603
+886-2-2627-2707
info@altrubio.com

Media Contact:
Darren Opland, PhD
LifeSci Communications
+1-646-627-8387
darren@lifescicomms.com

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