SAN FRANCISCO, CA, USA I January 23, 2023 I 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 it has dosed the first patient in a Phase 1 study evaluating ALTB-268, its next-generation PSGL-1 antibody agonist serving as an immune checkpoint enhancer (ICE), in healthy volunteers.
“The dosing of the first patient in this Phase 1 clinical trial represents a major milestone for AltruBio, and we look forward to executing on the clinical potential of ALTB-268, our next-generation, subcutaneously administered ICE,” said Judy Chou, Ph.D., President and Chief Executive Officer of AltruBio. “We are thrilled to bring ALTB-268 into the clinic to evaluate its safety and tolerability as a first step towards providing not only a more conveniently administered but potentially more durable and effective treatment option for patients suffering from immunological diseases including ulcerative colitis. The Phase 1 study was built on the clinically validated mechanism of action and strong preclinical data which showcased the improved potency in eliminating pathogenic chronic T cells. We believe ALTB-268 can realize the ‘pipeline-in-a-product’ potential for multiple autoimmune and inflammatory diseases in a patient population with high unmet medical needs.”
The Phase 1 trial in healthy volunteers is a randomized, double-blind, single- and multiple- ascending dose study evaluating the safety, tolerability, pharmacokinetic/pharmacodynamic and immunogenicity of ALTB-268.
ALTB-268 is a next-generation PSGL-1 antibody agonist that acts as an immune checkpoint enhancer (ICE) that downregulates 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. Its unique mechanism of action is the same as first-generation ICE, ALTB-168, which has previously obtained promising Phase 2a results in ulcerative colitis, psoriasis, psoriatic arthritis, and SR/TR-aGVHD. 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 a 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, 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. ALTB-268 is now being evaluated in a Phase 1 clinical trial before advancing towards clinical studies in multiple autoimmune and inflammatory disorders.