Alpine Immune Sciences Provides Clinical Update of its Phase 1 Trial of ALPN-101 in Healthy Volunteers at the European League Against Rheumatism (EULAR) E-Congress 2020
-- ALPN-101 was well tolerated and exhibited potent pharmacodynamic activity, enabling Phase 2 development --
The poster, entitled “A Double Blind, Placebo Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study of ALPN-101, a First-in-Class Dual ICOS/CD28 Antagonist, in
This first-in-human study (NCT03748836) randomized 96 healthy adults to receive single or multiple, intravenous or subcutaneous, placebo or ALPN-101 at doses ranging from 1 μg/kg to 10 mg/kg. At all dose levels, ALPN-101 was well tolerated with no severe adverse events, clinically-significant immunogenicity events, or evidence of cytokine release. Pharmacokinetics and pharmacodynamics exhibited desirable dose dependence, with increasing doses corresponding to increasing duration of complete or near-complete target saturation, as well as inhibition of antibody responses to keyhole limpet hemocyanin (KLH) immunization.
“These findings extend upon the previously disclosed single ascending dose data and continue to encourage us regarding ALPN-101’s future potential,” said
A copy of the poster is available in the “Scientific Publications” section of Alpine’s website at www.alpineimmunesciences.com.
ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD™), a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely playing a role in multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease, and multiple sclerosis, ALPN-101 demonstrates efficacy superior to agents blocking the CD28 - CD80/86 and/or ICOS - ICOSL pathways alone. A phase 1b/2 trial of ALPN-101 in acute GVHD (BALANCE, NCT04227938) has been initiated.
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