Positive Results from Phase 3 Clinical Trial of Izokibep in Hidradenitis Suppurativa to be Presented at EADV 2024 in Late-Breaking Session

News

September 19, 2024

Stockholm, Sweden, September 19, 2024. Affibody today announced that the positive results from a Phase 3 trial of izokibep in hidradenitis suppurativa will be presented at the 2024 European Academy of Dermatology and Venereology (EADV 2024) taking place September 25-28, 2024, in Amsterdam, Netherlands.

As announced by Affibody’s partner ACELYRIN, INC. on August 13, 2024, the Phase 3 trial of the Affibody® molecule izokibep in patients with hidradenitis suppurativa achieved its primary endpoint of HiSCR75 at 12 weeks, as well as the key secondary endpoints of HiSCR90 and HiSCR100.

Dr. Kim Papp will present the study results in a late breaking oral presentation at EADV 2024 on Wednesday, September 25, 2024. Presentation details are as follows:

Title: Efficacy and Safety of Izokibep, a Novel IL-17A Inhibitor, in Moderate-to-Severe Hidradenitis Suppurativa: Week 12 Results from a Randomized, Double-Blind, Placebo Controlled, Multicenter, Phase 3 Study
Date/Time: Wednesday, September 25, 2024; 4:00 – 4:15PM CEST
Presenter: Kim Papp, M.D., Ph.D., President and Director of Research, Probity Medical Research, Inc.
Abstract ID: 7995

Additional information about EADV 2024 is available at: https://eadv.org/congress/.

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. 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.

Izokibep is being evaluated in multiple late-stage trials in moderate-to-severe hidradenitis suppurativa, psoriatic arthritis, and uveitis. Top-line data from the ongoing Phase 2b/3 trial of izokibep in uveitis is expected in the fourth quarter of 2024.

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

About Hidradenitis Suppurativa

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease causing scarring, abscesses, malodor, and severe pain. HS typically occurs in areas with high concentrations of sweat glands and is typically accompanied by pain, malodor, drainage, and disfigurement that contribute to disability and a devastating impact on quality of life. Patients with HS miss a greater number of days of work and have increased disability compared to the average population.

HiSCR measures response to treatment in HS with HiSCR75 indicating at least a 75% reduction in total abscess and inflammatory nodule count (AN count), with no increase in abscess count, and no increase in draining fistula count relative to baseline. Higher orders such as HiSCR90, and HiSCR100 indicate 90%, and 100% reduction respectively.

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 Results from Phase 3 Clinical Trial of Izokibep in Hidradenitis Suppurativa to be Presented at EADV 2024 in Late-Breaking Session