Histopathological image of the active stage of ulcerative colitis. Credit: User:KGH / commons.wikimedia.org.

AltruBio has dosed the first subject in a Phase I clinical trial of its next-generation PSGL-1 antibody agonist, ALTB-268, in healthy volunteers to treat ulcerative colitis.

The double-blind, randomised, single- and multiple- ascending dose Phase I trial will assess the tolerability, safety, pharmacokinetics/pharmacodynamics, and immunogenicity of ALTB-268, which acts as an immune checkpoint enhancer (ICE).

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AltruBio president and CEO Judy Chou said: “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 I 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 realise the ‘pipeline-in-a-product’ potential for multiple autoimmune and inflammatory diseases in a patient population with high unmet medical needs.”

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Interim data from the Phase I trial is expected in the first half of this year, with plans to follow with a Phase II study commencement in ulcerative colitis.

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Without interfering with cell migration, ALTB-268 helps to restore the immune system to a state of balance.

ALTB-268 is a tetravalent version of ALTB-168 and is currently being evaluated in a Phase I study, prior to advancing towards clinical studies in several inflammatory and autoimmune disorders.

The unique mechanism of action of the antibody agonist is the same as first-generation ICE, ALTB-168.

Earlier, ALTB-168 obtained positive Phase IIa results in ulcerative colitis, psoriasis, psoriatic arthritis, and SR/TR-aGVHD.