SAN FRANCISCO, Jan. 19, 2023 (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 David T. Rubin, M.D., Professor of Medicine at the University of Chicago and AltruBio Scientific Advisory Board member, will share a poster presentation on first-generation immune checkpoint enhancer (ICE), ALTB-168 (neihulizumab), at the Crohn’s & Colitis Congress 2023, to be held in Denver, Colorado on January 19-21, 2023.
The poster being presented on-site by Dr. Rubin will provide data on the Phase 2 open label study of ALTB-168 (neihulizumab) in patients with moderately to severely active anti-TNFα and/or anti-integrin refractory ulcerative colitis (UC).
“With more than three million people in the U.S. suffering from inflammatory bowel disease, there remains a significant unmet need for novel therapies to achieve sustained remission,” said Dr. Rubin. “I am pleased to present results that demonstrate the safety and tolerability of neihulizumab as well as promising signals of response and remission in this particularly tough to treat group of patients.”
Jesse Hall, M.D., Chief Medical Officer of AltruBio, added, “We’re pleased to share data supporting favorable safety and clinical benefit as a result of downregulating activated T cells through the unique mechanism of action targeting PSGL-1. With the promising data of ALTB-168 in UC, our next generation ICE ALTB-268, a tetravalent version of ALTB-168, has been developed in a patient-friendly, subcutaneous dosage form and will expand the potential to treat patients suffering from a variety of autoimmune and immune-mediated inflammatory diseases, including UC. We look forward to sharing more clinical progress this year.”
The ALTB-168 (neihulizumab) Phase 2 trial is an open label, single arm, multiple dose proof of principle study to evaluate efficacy, safety, tolerability, and immunogenicity of ALTB-168 in patients with moderate to severe active UC who are refractory or intolerant to anti-TNFα and/or anti-integrin therapy. Two regimens were tested: 5 weekly IV doses plus 3 bi-weekly IV doses of 9 mg/kg ALTB-168 (5+3 regimen), and 8 weekly IV doses plus 2 bi-weekly IV doses of 9 mg/kg ALTB-168 (8+2 regimen). More information about the trial is available on clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT03298022).
Data highlights include:
- In the 5+3 regimen, among the 10 enrolled subjects, 9 were included in the efficacy analysis where 2 (22%) subjects achieved clinical response at Week 12 and 1 (11%) subject achieved clinical response at Week 2.
- In the 8+2 regimen, among 14 enrolled subjects, 7 (50%) subjects achieved clinical response and 29% achieved clinical remission at Week 12.
Details about the poster presentation are as follows:
Title: A Phase II Open Label Study of Neihulizumab, an anti-CD162 (PSGL-1 ) antibody, in patients with moderate to severe active, anti-TNFα and/or anti-integrin refractory ulcerative colitis
Presentation Number: P037
Presenter: David T. Rubin, M.D., University of Chicago
Date: Thursday, January 19, 2023
Time: 7:15 p.m. – 8:30 p.m. ET
Location: Exhibit/Poster Hall (Aurora Halls 1/2) – Gaylord Resort
For more information and to register for the Crohn’s & Colitis Congress 2023, visit the conference website.
ALTB-168 is an immune checkpoint enhancer that regulates T cell homeostasis. The unique mechanism of action of this agonist antibody maintains T cell homeostasis by preferentially inducing downregulation of activated T cells, potentially sparing resting T cells and early-activated T cells. Because pathogenic T cells involved in inflammatory conditions are usually in an activated and/or auto-activated states, eliminating this population of cells can potentially control inflammation in T cell associated diseases, such as UC.
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, ALTB-168, a PSGL-1 agonist antibody serving as an immune checkpoint enhancer (ICE), 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 ICE, ALTB-268, is a tetravalent version of ALTB-168 and has demonstrated higher potency via the same mechanism, making it suitable for subcutaneous administration. The IND for ALTB-268 has been accepted and ALTB-268 is advancing towards clinical studies in multiple autoimmune and inflammatory disorders.
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