Affibody’s partner ACELYRIN has announced that the Phase 3 trial of the Affibody molecule izokibep in patients with hidradenitis suppurativa (HS) achieved its primary endpoint of HiSCR75 at 12 weeks, as well as the key secondary endpoints of HiSCR90 and HiSCR100.
“We are delighted that the Phase 3 HS trial of izokibep was successful, again confirming the strength of the Affibody platform in immunology and inflammation. Today’s positive HS data and previously announced psoriatic arthritis (PsA) data support a path to approval for izokibep,” says David Bejker, Chief Executive Officer of Affibody. “Our partner ACELYRIN has determined that a program of this breadth and size is best brought to market by a larger organization with the resources and existing footprint in these indications. Given our continuing confidence in izokibep’s best-in-class potential, underpinned by the breadth of efficacy and safety data generated across multiple indications, we will work with ACELYRIN to bring izokibep to patients in need of novel treatments.”
In addition to the positive Phase 3 HS results, ACELYRIN has announced that they will complete the ongoing HS and PsA trials but will not initiate the planned additional Phase 3 studies of izokibep in these indications.”
In addition to the positive Phase 3 HS results, ACELYRIN has announced that they will complete the ongoing HS and PsA trials but will not initiate the planned additional Phase 3 studies of izokibep in these indications. Top-line data from the ongoing Phase 2b/3 trial of izokibep in uveitis are expected in the fourth quarter of 2024.
“We are pleased that the Phase 3 HS trial of izokibep met its primary endpoint and provided clinically meaningful responses as early as week 12 in this devastating disease. Importantly, we are further encouraged by the deepening responses seen at week 16, with a quarter of the patients achieving HiSCR100. Past experience tells us these responses will deepen even further with continued treatment,” says Nikolai Brun, Chief Medical Officer of Affibody. “These results demonstrate that targeting IL-17A alone with greater potency can achieve the same or greater clinical responses than agents targeting IL-17 subunits more broadly, without their associated safety liabilities.”
Photo of David Bejker: Affibody
