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Positive Phase 2 Clinical Results for Izokibep in Psoriatic Arthritis Published
2025-04-29 11:45:00

Solna, Sweden, April 29, 2025. Affibody AB (“Affibody”) today announced that a publication outlining the positive results from a Phase 2 clinical study with izokibep, a next generation IL-17 inhibitor, in psoriatic arthritis (PsA) is available online.

The article, with the title “Efficacy and safety of izokibep in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study”, is published in Annals of the Rheumatic Diseases, which is the leading rheumatology journal.

The Phase 2 clinical study of izokibep in 135 patients with PsA met its primary endpoint of ACR50 at week 16 with high statistical significance compared to placebo as well as several clinically important secondary endpoints including Psoriasis Area and Severity Index (PASI) response and quality of life improvement. The treatment with izokibep continued for up to 46 weeks with increasing improvements in key manifestations of disease. Izokibep was well-tolerated in line with previous studies.

“We are delighted that the clinical study data have been published in this prestigious journal further validating the successful results,” said David Bejker, CEO of Affibody.

Citation and link to publication
P.C. Taylor et al., Efficacy and safety of izokibep in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study, Ann Rheum Dis (2025), https://doi.org/10.1016/j.ard.2025.02.019

About izokibep

Izokibep is an Affibody® molecule 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. 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 has been administered to more than a thousand patients, some of whom have been dosed for more than three years.

Late-stage trials of izokibep in hidradenitis suppurativa (HS) and psoriatic arthritis (PsA) have demonstrated levels of clinical response comparable with next generation approaches to IL-17 inhibition. These data also demonstrate that targeting IL-17A alone with greater potency can achieve the same or better clinical responses than agents targeting IL-17 subunits more broadly than IL-17A, without their associated safety liabilities.

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 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.

Disclaimer

This press release contains forward-looking statements. While Affibody consider the projections to be based on reasonable assumptions, these forward-looking statements may be called into question by several hazards and uncertainties, so that actual results may differ materially from those anticipated in such forward-looking statements.

Contacts

Affibody
David Bejker, CEO, +46 706 454 948
Peter Zerhouni, CFO and CBO, +46 706 420 044

Affibody Media Contact
Richard Hayhurst/Ola Björkman, RHA Communications, +44 7711 821 527, richard@rhacomms.eu

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Positive Phase 2 Clinical Results for Izokibep in Psoriatic Arthritis Published

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