Therapy Areas: Autoimmune
First Patient Dosed in Synergy, ALPN-101 Phase 2 Lupus Clinical Trial and USD 45m in Development Milestones Achieved Under AbbVie Collaboration
24 June 2021 - - The first patient has been dosed in Synergy, a Phase 2 study of ALPN-101 in patients with Systemic Lupus Erythematosus, US-based clinical-stage immunotherapy company Alpine Immune Sciences, Inc. (NASDAQ: ALPN) said.

Alpine also announced the achievement of USD 45m in pre-option exercise development milestones as part of the 2020 Option and License Agreement with AbbVie.

Synergy (NCT04835441) is a global, randomized, double-blind, placebo-controlled Phase 2 clinical trial of ALPN-101 in moderate-to-severe systemic lupus erythematosus patients. It initiated enrollment in June 2021.

ALPN-101 is a first-in-class, dual inhibitor of the CD28 and ICOS T-cell costimulatory pathways being developed for treatment of systemic lupus erythematosus.

By simultaneously blocking two key costimulatory pathways, ALPN-101 has the potential to improve outcomes in patients suffering from severe autoimmune/inflammatory diseases.

Preclinical studies have demonstrated efficacy in models of SLE, Sjögren's syndrome, arthritis, inflammatory bowel disease, multiple sclerosis, type 1 diabetes, uveitis, and graft versus host disease. In a Phase 1 study in healthy adult volunteers, ALPN-101 was well-tolerated, and exhibited dose-dependent pharmacokinetics and pharmacodynamics.

In June 2020, Alpine entered into an exclusive worldwide option and license agreement with AbbVie for ALPN-101. Prior to the exercise of the license option, Alpine will conduct ALPN-101 development efforts, including a Phase 2 study in systemic lupus erythematosus.

Upon exercise of the option, AbbVie will conduct all future clinical development, manufacturing, and commercialization activities for ALPN-101.

Under the terms of the agreement, Alpine received an upfront payment of USD 60m, has achieved USD 45m of the USD 75m pre-option exercise development milestones, and will also be eligible to receive up to an aggregate of USD 730m for exercise of the option and success-based development, regulatory and commercial milestones.

Alpine Immune Sciences is seeking to create first- or best-in-class multifunctional immunotherapies via unique protein engineering technologies.
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