AltruBio Announces FDA Clearance of IND Application for ALTB-268, a Next-Generation Immune Checkpoint Enhancer for the Treatment of Ulcerative Colitis

-Next-generation PSGL-1 agonist antibody with clinically proven mechanism of action receives IND clearance-

-Phase 1 clinical trial expected to launch in 1H 2023 and will evaluate the safety, tolerability, PK/PD, and immunogenicity of ALTB-268 in healthy volunteers-

SAN FRANCISCO, Dec. 06, 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 clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical study of ALTB-268 in healthy volunteers..

“Obtaining IND clearance to advance ALTB-268 into the clinic represents an important milestone for our pipeline-in-a-product platform. We are excited about the prospects of how our next-generation PSGL-1 agonist immune checkpoint enhancer can address the unmet medical needs of patients with chronic autoimmune diseases,” said Judy Chou, Ph.D., President and Chief Executive Officer of AltruBio. “Current therapies for autoimmune diseases globally suppress the immune response, potentially resulting in undesirable results. We are eager to demonstrate that ALTB-268 can treat immune disorders at the source of issues without compromising the overall immune response.”

About ALTB-268
ALTB-268 is a next-generation PSGL-1 antibody agonist that acts as an immune checkpoint enhancer (ICE) that downregulate chronically activated T-cells by inhibiting the T-cell effector function, promoting T-cell exhaustion and apoptosis. PSGL-1 plays a key role in regulating late-stage, chronically activated T-cells. ALTB-268 helps to restore the immune system to a state of balance without interfering with cell migration. It’s unique mechanism of action is the same as first-generation ICE, ALTB-168, which has previously obtained promising phase 2a results in ulcerative colitis. ALTB-268 can be administered subcutaneously and is potentially more potent than the company’s first-generation molecule.

The Phase 1 study will examine the safety and tolerability in healthy volunteers with anticipated interim data in 1H 2023, with plans to follow with initiation of the Phase 2 study in ulcerative colitis.

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, an immune checkpoint agonist antibody targeting PSGL-1 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.


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LifeSci Communications
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