Affibody and Inmagene autoimmune partnership completes regulatory milestone

09-Mar-2021 - Last updated on 09-Mar-2021 at 16:28 GMT

Affibody and Inmagene Biopharmaceuticals report that the US FDA has cleared the interleukin-17 (IL-17) blocker, izokibep, to proceed to phase 2 clinical development in non-infectious intermediate, posterior, and pan-uveitis.

Uveitis is an orphan disease with significant unmet medical need. It is an inflammation of the uveal tract but can also include the inflammation of nearby tissues, such as the retina, the optic nerve, and the vitreous humor. It is one of the leading causes of blindness worldwide.

Sweden’s Affibody and Inmagene, which has wholly owned subsidiaries in San Diego, Shanghai, and Hangzhou, are jointly developing izokibep, a novel bispecific agent, targeting both subunits of IL-17A as well as albumin, to treat multiple autoimmune diseases.

Affibody is managing the global clinical trials for uveitis.

The phase 2 trial testing the efficacy and safety of izokibep in the treatment and prevention of relapse/recurrence of non-infectious intermediate, posterior or pan-uveitis, the LINNAEA study - includes an initial pilot phase. The study will run for one year; it will evaluate IL-17 blocker in 110 patients, and will comprise around 50 trial sites in Europe and North America.

David Bejker, CEO of Affibody, said the phase 2 trial has been developed in close collaboration with leading ophthalmologists.

“We have designed the study to evaluate the role of izokibep as a first-line therapeutic option for active non-infectious uveitis as well as a steroid-sparing immunomodulatory agent,” added Dr Quan Dong Nguyen, principal coordinating investigator, the LINNAEA Study, and professor of ophthalmology at the Byers Eye Institute, Stanford University School of Medicine.

Going beyond uveitis

Affibody and Inmagene will continue to file additional investigational new drug (IND) applications in autoimmune diseases during 2021.

Bejker told BioPharma-Reporter that IL-17 is a central node in inflammatory disease and the company believes there is significant untapped potential in the IL-17 biology, especially in specialty indications.

In terms of which other indications the partners might be focusing on, he explained that Affibody undertook a big-data supported review, mining the universe of IL-17 driven indications for potential focus areas:

“We looked at more than 800 indications and ended up with a long list of more than 150 that have been reported to be associated with IL-17. Out of this set we have selected a number of areas where we believe there is a unique fit for us, including spondyloarthritis (i.e. PsA and axSpa), ophthalmology (i.e. uveitis), vessels (where we have plans to start studies in Takayasu’s arteritis), and neuroinflammation (where we have early KOL interactions).”