Izokibep meets ACR50 endpoint in PsA, has ‘deepening’ benefit in hidradenitis suppurativa
Click Here to Manage Email Alerts
Key takeaways:
- Izokibep achieved ACR50 response at week 16 in a phase 2b/3 PsA trial and showed continued benefit in a hidradenitis suppurativa open-label extension.
- The IL-17A inhibitor maintained favorable safety in each trial.
Izokibep achieved the primary endpoint of ACR50 response in a phase 2b/3 psoriatic arthritis trial, and demonstrated sustained, “deepening” benefit in hidradenitis suppurativa, according to top-line data from its manufacturer.
In a press release, Affibody Medical AB added that the drug additionally exhibited “robust clinical responses” for ACR70 and Psoriasis Area and Severity Index 100, as well as composite endpoints of ACR50/PASI100 and minimal disease activity, in PsA.
“It is encouraging to see the positive effect of izokibep in these hard-to-treat patients,” Nikolai Brun, MD, PhD, chief medical officer of Affibody Medical AB, which has licensed the drug to Acelyrin and Inmagene Biopharmaceuticals, said in the release. “High orders of response, such as ACR70 in PsA and HiSCR100 in [hidradenitis suppurativa], demonstrate the unique ability of izokibep to help patients otherwise inadequately treated.”
In the PsA trial, the interleukin-17A inhibitor met ACR50 at week 16 with “high statistical significance,” with additional responses seen in ACR70 and PASI 100, read the release. The drug was well-tolerated, with a discontinuation rate of less than 3%, according to the data. The company stated that the trial is expected to be the first of two registrational trials.
Meanwhile, in a 32-week open-label extension of the phase 2b hidradenitis suppurativa trial, izokibep continued leading to clinical improvements while maintaining a favorable safety profile. Patients switching to izokibep at week 16 achieved similar response to those treated at baseline, according to the release.
“We are pleased to see the exciting results — especially the robust placebo crossover responses — from this long-term follow-up in [hidradenitis suppurativa], despite the initial primary endpoint of this study not meeting statistical significance,” Affibody CEO David Bejker said in the release. “The [hidradenitis suppurativa] data together with the positive data on PsA bolsters our excitement for izokibep and confirms izokibep as a leading candidate among the next generation of IL-17 treatments.”
An ongoing phase 3 trial in hidradenitis suppurativa is expected to release top-line data this year, with another planned in “approximately 400 patients to address FDA guidance on size of safety database,” according to the release.
Read more about
Click Here to Manage Email Alerts