The next generation biopharmaceuticals

Positive Top-line Clinical Data for Izokibep in Hidradenitis Suppurativa

2023-01-05

Positive Top-line Clinical Data for Izokibep in Hidradenitis Suppurativa

• Izokibep achieves higher orders of Hidradenitis Suppurativa Clinical Responses (HiSCR) in an open label part of the ongoing Phase 2b/3 trial.

• Safety results consistent with previous trials of izokibep and the IL-17Ai class, with no increased risk of infection, including candida infections.

Solna, Sweden, January 5, 2023. Affibody’s partner ACELYRIN, Inc. today announced top-line 12-week open label data from a Phase 2b/3 trial of izokibep in patients with moderate-to-severe Hidradenitis Suppurativa (HS).

The 30-patient open label Part A of the Phase 2b/3 trial (NCT05355805) evaluated clinical response and safety of izokibep administered via subcutaneous injection to patients with moderate-to-severe HS. Izokibep demonstrated higher orders of Hidradenitis Suppurativa Clinical Responses, where low-to-no placebo responses have been reported historically. The safety data reported were consistent with previous trials of izokibep as well as the IL-17Ai class. Notably, there was no evidence of increased risk of infection and no candida infections were reported in this trial.

The full data from Part A of this trial will be presented at a future scientific meeting. The double-blind, placebo-controlled Part B of this Phase 2b/3 trial is ongoing, and based on the Part A results, ACELYRIN will accelerate initiation of the second confirmatory trial in HS.

About Hidradenitis Suppurativa

Hidradenitis Suppurativa (HS) is an autoimmune disease characterized by inflammation of the exocrine glands and leading to skin abscesses, pain, scarring, malodor, and a devasting impacting on patient’s ability to perform ordinary daily tasks and quality of life. HS is typically painful and may significantly limit everyday activities, for instance, walking, hugging, moving, and sitting down.

About izokibep

Izokibep has been administered to over 300 patients, some for up to three years. It is a small therapeutic protein inhibitor of interleukin-17A (IL-17A) designed to overcome the limitations of monoclonal antibodies. With high potency and small molecular size – about one tenth the size of a traditional monoclonal antibody – izokibep can reach high drug exposure levels through a single, subcutaneous injection that monoclonal antibodies otherwise require IV administration to achieve.

Izokibep is based on Affibody’s proprietary technology platform, Affibody® molecules, and has been partnered with Inmagene Biopharmaceuticals Co. Ltd. and ACELYRIN Inc. Affibody has retained the marketing rights for the Nordic countries.

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

Camilla Danell, CFO

+46 706 454 948

+46 761 148 910

Affibody Investor Contact

Alexandra Roy

aroy@soleburytrout.com

Affibody Media Contact

Richard Hayhurst/Ola Bjorkman

+44 7711 821 527

RHApr

richard@rhapr.eu

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.

Affibody in short

Affibody is a Swedish biotech company focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod™.

Upcoming reports Financial calendar

  • Interim Report January to March 2020 (May 15, 2020)
  • Interim Report January to June 2020 (August 21, 2020)
  • Interim Report January to September 2020 (November 13, 2020)
  • Year End Report 2020 (February 2021)