1 Phase 2b/3 trial in moderate to-severe hidradenitis suppurativa (HS) and uveitis. Planned inclusion into registrational package for HS and non-infectious uveitis (as applicable) if granted orphan drug designation and following consultation with relevant health authorities. We have not previously completed any clinical trials for uveitis and are currently conducting our first Phase 2b/3 trial.
2 Phase 2b/3 trial in PsA.
3 IL-17A Inhibitor; Excludes (i) development, commercialization and manufacturing rights in mainland China, Hong Kong, Macau, South Korea and Taiwan, and (ii) development rights in certain other Asia Pacific countries including, without limitation, Australia, India, New Zealand and Singapore. We retain decision making authority for izokibep global development. Potential opportunity to extend certain IP protection into early 2040’s.
4 Based on data from our Phase 2 and ongoing Phase 2b/3 trials in PsA, we intend to discuss with the FDA initiation of the Phase 3 program in AxSpA without completing earlier clinical trials in AxSpA. The FDA may require us to complete a Phase 2 trial in AxSpA prior to initiating our planned Phase 3 program.
5 Worldwide rights to non-oncology indications. Potential opportunity to extend certain IP protection into 2043.
6 Potential opportunity to extend certain IP protection to 2039.
7 Based on preclinical studies demonstrating highly potent inhibition of the c-KIT pathway targeting mast cell proliferation and degranulation across mast-cell driven diseases such as Chronic Urticaria, an inflammatory disease that is driven by the release of histamine and other vasoactive molecules produced by mast cells.
Hidradenitis suppurativa (HS) is a very painful, lifelong, and recurring skin condition that causes abscesses and scarring 1,2. Areas often affected include the groin and genitals, the armpits, areas around the anus, and below the breasts1,2.