Hidradenitis Suppurativa Treatment Shows Positive Results in Phase 3 Trial
Izokibep from Affibody is a small therapeutic protein designed to inhibit IL-17A.
Positive results have been announced from a global phase 3 trial that’s evaluating the safety and efficacy of izokibep for the treatment of hidradenitis suppurativa in adults, Affibody announced in a news release.1
Hidradenitis Suppurativa Treatment Shows Positive Results in Phase 3 Trial / MdBabul - stock.adobe.com
Data from the phase 3 trial (NCT05905783) showed that izokibep met its primary endpoint of a Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at 12 weeks. The therapy also met its key secondary endpoints of HiSCR90 and HiSCR100. HiSCR is an evaluation method for hidradenitis suppurativa treatment and includes the following criteria: 50% or more reduction in the number of inflammatory lesions; no increase in the number of abscesses; and no increase in the number of draining fistulas.2
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“We are pleased that the phase 3 hidradenitis suppurativa trial of izokibep met its primary endpoint and provided clinically meaningful responses as early as week 12 in this devastating disease,” Nikolai Brun, chief medical officer at Affibody, said in a release.1 “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.”
Izokibep is a small therapeutic protein designed to inhibit IL-17A. It was created by Affibody as part of the company’s novel drug class of molecules that are similar to monoclonal antibodies and antibody fragments. Izokibep has potential for robust tissue penetration due to its size, which Affibody hypothesizes may provide clinically meaningful and differentiated benefits for patients.
The izokibep study was a randomized, double-blind, placebo-controlled, multicenter phase 3 trial evaluating the therapy in adult patients with a moderate to severe hidradenitis suppurativa diagnosis for at least 6 or more months prior to study enrollment. The study cohort included 258 patients who received either 160 mg izokibep administered via subcutaneous injection or placebo.
At 12 weeks, 33% of patients who received the therapy achieved HiSCR75 compared to 21% in the placebo group. For HiSCR90 and HiSCR100, 25% and 22% of patients in the izokibep group achieved those endpoints, respectively. Preliminary data through week 16 also showed that 40% of patients in the therapy group achieved HiSCR75, demonstrating a deepening response over time.
Additionally, izokibep was seen to be well tolerated and no new safety signals were identified in the trial. Investigators said the fact that there were no cases of candida infection, liver toxicity or suicidal ideation or behavior in patients who received the therapy was of particular note.
“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,” David Bejker , CEO at Affibody, said in a release.1 “Today’s positive hidradenitis suppurativa data and previously announced psoriatic arthritis data support a path to approval for izokibep…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 [our partner] Acelyrin to bring izokibep to patients in need of novel treatments.”
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References
1. Positive Phase 3 Results in Hidradenitis Suppurativa Further Strengthen Competitive Profile of Izokibep. News Release. Affibody. August 13, 2024. Accessed August 14, 2024. https://www.affibody.se/press/positive-phase-3-results-in-hidradenitis-suppurativa-further-strengthen-competitive-profile-of-izokibep/
2. Kimball AB, Jemec GB, Yang M, et al. Assessing the validity, responsiveness and meaningfulness of the Hidradenitis Suppurativa Clinical Response (HiSCR) as the clinical endpoint for hidradenitis suppurativa treatment. Br J Dermatol. 2014 Dec;171(6):1434-42. doi: 10.1111/bjd.13270. Epub 2014 Nov 11. PMID: 25040429.
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