The Phase I trial will assess single and multiple-ascending intravenous and / or subcutaneous doses. Credit: Hush Naidoo on Unsplash. Alpine Immune Sciences has commenced dosing of patients in a Phase I clinical trial of its investigational product ALPN-101 intended for treating autoimmune and inflammatory diseases.
ALPN-101 is a first-in-class dual ICOS/CD28 inhibitor that consists of an Fc fusion protein of human inducible T cell co-stimulator ligand (ICOSL) variant immunoglobulin domain vIgD.
CD28 and ICOS are costimulatory molecules associated with autoimmune and inflammatory diseases.
The randomised, first-in-human trial will assess the safety and tolerability of single and multiple-ascending intravenous and / or subcutaneous doses of ALPN-101.
The placebo-controlled, blinded study will also monitor the product’s pharmacokinetics, pharmacodynamics and exploratory biomarkers in order to establish its potential to treat autoimmune and inflammatory disorders.
Alpine Immune Sciences executive chairman and CEO Mitchell Gold said: “This first dosing in the initial clinical trial of ALPN-101 is an important milestone for Alpine as we have now transitioned to a clinical-stage development company.
“We look forward to further exploring how our first-in-class dual ICOS/CD28 antagonist will potentially improve outcomes of patients suffering from debilitating autoimmune and inflammatory diseases such as GvHD and psoriatic arthritis.”
The Phase I trial will be conducted in two parts and will enrol around 104 healthy volunteers at a single clinical site in Australia.
The first part of the trial will see subjects administered with a single dose of ALPN-101 or placebo, while the second part will involve four doses.
Alpine Immune expects to complete the trial by November this year.
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