ACELYRIN, INC., Affibody AB, and Inmagene Biopharmaceuticals, today announced that a 16-week, global, Phase 2 clinical trial of izokibep in patients with psoriatic arthritis (PsA) met its primary endpoint in a pre-specified interim analysis.
The double-blind, placebo-controlled Phase 2 clinical trial, designed and conducted by Affibody AB, evaluated the safety and efficacy of izokibep dosed 80 mg every two weeks (Q2W) or 40 mg Q2W, versus placebo Q2W, in adult patients with active PsA. The interim analysis primary endpoint was ACR50 at 16 weeks. No new safety issues were identified.
"There are now two positive Phase 2 trials with izokibep, one in PsA and one in psoriasis, both demonstrating the safety and efficacy of izokibep and highlighting its potential as a therapeutic across multiple IL-17 driven diseases," said Paul Peloso, MD, chief medical officer (CMO) of ACELYRIN. "We look forward to the trial continuation and presenting results in a future scientific forum."
"Psoriatic arthritis is a painful and debilitating inflammatory disease of the peripheral joints, skin, and nails, and can also involve the spine. We are pleased this Phase 2 trial met its primary endpoint while also confirming the safety of izokibep," commented Prof. Nikolai Brun, CMO of Affibody.
"This is an important milestone to the overall advancement of izokibep," said Jean-Louis Saillot, MD, chief development officer of Inmagene. "We look forward to working closely with our partners ACELYRIN and Affibody to advance the global programs targeting multiple autoimmune indications."
More than 300 patients have been exposed to izokibep to date, many for up to three years. The interim PsA Phase 2 trial data confirm the safety profile of izokibep and support the strategy of fully evaluating IL-17A inhibition in pursuit of transformative efficacy across many disease states.
ACELYRIN holds worldwide rights to izokibep except development and commercialization by Inmagene in selected Asian countries, including China, Hong Kong, Macau, South Korea, and Taiwan, and excluding Japan, and commercialization by Affibody in the Nordic countries.
Izokibep is a unique, antibody mimetic, interleukin-17A (IL-17A) inhibitor designed to overcome the limitations of monoclonal antibodies. With extraordinary potency and small molecular size, izokibep can reach high drug exposure levels through a single, subcutaneous injection that monoclonal antibodies require IV administration to achieve. In addition, the small size of izokibep—about a tenth the size of a monoclonal antibody —also enables its potential to reach targeted tissues that may otherwise be inaccessible to the much larger monoclonal antibodies.
ACELYRIN, INC. is a biopharma company focused on providing patients life- changing new treatment options by identifying, acquiring, and accelerating development and commercialization of promising drug candidates and leveraging its expertise to rapidly advance these medicines to patients. For more information, please visit acelyrin.com.
Affibody AB is a clinical-stage biopharmaceutical company with a broad product pipeline focused on developing innovative bi- and multi-specific next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod®. Affibody AB is a holding of Patricia Industries. For more information, please visit affibody.com.
Inmagene Biopharmaceuticals, with wholly owned subsidiaries in San Diego, Shanghai, Hangzhou, and Sydney, is a leading biotech company focused on immunology-related therapeutic areas. Believing in "borderless innovation," the Inmagene team integrates efficient resources worldwide to develop drugs for patients globally. Inmagene is operating twelve "Smart Innovation" programs to create and develop novel drug candidates for the global market. For more information, please visit inmagenebio.com.
This press release contains forward-looking statements. While ACELYRIN, INC., Affibody AB, and Inmagene Biopharmaceuticals consider the projections to be based on reasonable assumptions, these forward-looking statements may be called into question by a number of hazards and uncertainties, so that actual results may differ materially from those anticipated in such forward-looking statements.