Positive 16-week Data From Phase 2b/3 Trial of Izokibep in Psoriatic Arthritis Presented at EULAR 2024 Late Breaking Session

News

June 5, 2024

Stockholm, Sweden, June 5, 2024. Affibody today announced that positive 16-week data from a global Phase 2b/3 trial of izokibep in psoriatic arthritis (PsA) will be presented at the 2024 European Alliance of Associations for Rheumatology Congress (EULAR 2024) taking place June 12-15 in Vienna, Austria.

As announced by Affibody’s partner ACELYRIN, INC. on March 11, 2024, the Phase 2b/3 PsA clinical trial met the primary endpoint of ACR50 at 16 weeks versus placebo with high statistical significance.

Dr. Philip Mease will present the study results in a late breaking oral presentation at EULAR 2024 on Saturday, June 15, 2024.

Presentation details are as follows:
Title: Efficacy and Safety of Izokibep, a Novel IL-17A Inhibitor, in Patients with Active Psoriatic Arthritis: Week 16 Results from a Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2b/3 Study.
Date/Time: Saturday, June 15, 2024; 9:30am – 9:40am CEST.
Presenter: Philip Mease, MD, MACR, Director of Rheumatology Research at Swedish Medical Center, Seattle, USA.

The abstract is available at:
https://scientific.sparx-ip.net/archiveeular/?view=2&c=a&item=2024LBA0005

Additional information about EULAR 2024 is available at: https://congress.eular.org/.

About the Phase 2b/3 Psoriatic Arthritis clinical trial
The Phase 2b/3 clinical trial (NCT05623345) is a global, multi center, randomized double-blind, placebo-controlled, trial evaluating the safety and efficacy of izokibep dosed subcutaneously 160 mg every week (QW) or every two weeks (Q2W) and 80 mg every four weeks (Q4W) versus placebo. 351 adult patients with active PsA were enrolled across 71 sites in the United States and Europe and randomized across the four arms.

For more information about the Phase 2b/3 PsA clinical trial, please visit www.clinicaltrials.gov.

About Psoriatic Arthritis

Psoriatic arthritis (PsA) is a chronic immune-mediated inflammatory disease characterized by multiple manifestations including joint inflammation, skin lesions (psoriasis), and enthesitis (painful inflammation of the tissues that connect ligament and tendons to bone), all contributing to reduced quality of life and the risk of permanent disability. The pathology is dominated by pro-inflammatory T-helper (Th-17) cells that lead to over expression of IL-17, IL-23, and TNF cytokines. It is estimated that approximately 30% of people currently living with psoriasis will develop PsA over time. There remains a large unmet need for more effective therapies to treat PsA across all disease manifestations.

About izokibep

Izokibep is small protein Affibody® therapeutic designed to inhibit IL-17A with high potency through tight binding affinity, the potential for robust tissue penetration due to its small molecular size, about one-tenth the size of a monoclonal antibody, and an albumin binding domain that results in improved pharmacokinetic (PK) properties. Izokibep has been administered to more than a thousand patients, some of whom have been dosed for more than three years. Clinical trial data support the hypothesis that these unique characteristics of izokibep may provide clinically meaningful and differentiated benefits for patients, including resolution of key manifestations of disease.

Izokibep is being evaluated in multiple late-stage trials in moderate-to-severe hidradenitis suppurativa (HS), psoriatic arthritis (PsA), and uveitis, with plans to initiate an additional Phase 3 program in axial spondyloarthritis (AxSpA).

Affibody has licensed izokibep, to ACELYRIN, INC. and Inmagene Biopharmaceuticals Co. Ltd., while retaining an option to co-promote in the Nordic region.

About Affibody® molecules

Affibody® molecules are a novel drug class of small therapeutic proteins with characteristics surpassing monoclonal antibodies (mAbs) and antibody fragments. The Company has created a large library consisting of more than ten billion Affibody® molecules, all with unique binding sites, from which binders to given targets are selected. Affibody® molecules are only 6 kDa in size.

They have demonstrated clinical utilities both as tumor-targeting moieties through their small size and as efficacious disease blocking agents in autoimmune indications by utilizing the inherent properties that allow multi-specific formats.

About Affibody

Affibody is a clinical stage integrated biopharmaceutical company with a broad product pipeline focused on developing innovative bi- and multi-specific next generation biopharmaceutical drugs based on its unique proprietary technology platform, Affibody® molecules.

Through its validated business model, the company has a proven capability of identifying and prioritizing strategic projects in a timely and de-risked way. Affibody has established several partnerships for the development and commercialization of its innovations with international pharmaceutical companies.

Affibody’s main shareholder Patricia Industries is a part of Investor AB.

Further information can be found at: www.affibody.com.

Positive 16-week Data From Phase 2b/3 Trial of Izokibep in Psoriatic Arthritis Presented at EULAR 2024 Late Breaking Session