New Phase 3 Data Suggest Efficacy of Izokibep for Hidadenitis Suppurativa

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The phase 3 trial of izokibep (Affibody molecule) treatment of individuals with hidradenitis suppurativa (HS) successfully achieved its primary and secondary endpoints, an announcement by ACELYRIN, INC. suggests, highlighting the drug’s efficacy and safety for HS.^1,2

HS is a chronic, inflammatory skin condition which frequently appears in areas of the body with sweat glands, leading to abscesses, scarring, malodor, and severe pain. Individuals with HS are known to miss a greater number of work days and may also have greater disability versus the general population.

“We are delighted that the Phase 3 HS trial of izokibep was successful, again confirming the strength of (izokibep) in immunology and inflammation,” David Bejker, Chief Executive Officer of Affibody, said in a statement. “Today’s positive HS data and previously announced psoriatic arthritis (PsA) data support a path to approval for izokibep.”¹

Izokibep is a small protein Affibody therapeutic which was formulated to inhibit interleukin (IL)-17A. The treatment has the potential for robust tissue penetration given that it is only around 1-tenth the size of a monoclonal antibody.

The drug was evaluated in a phase 3 clinical trial (NCT05905783) in which it was subcutaneously administered at a 160 mg dose every week and compared with placebo. There were 258 participants with moderate-to-severe HS included in the study, and the investigators’ primary endpoint was the proportion of subjects achieving 75% Hidradenitis Suppurativa Clinical Response (HiSCR75) at the 12-week mark.

Secondary endpoints also assessed by the research team include HiSCR90 and HiSCR100 in addition to later time points. By the 16-week mark, subjects who were included in the placebo arm of the study were switched to izokibep 160 mg every week.

The investigators reported that 33% of subjects treated with izokibep 160 mg each week were able to successfully achieve HiSCR75 versus 21% of those given a placebo (P = .0294). In their higher order endpoints, 25% of individuals treated with izokibep achieved HiSCR90 versus 9% given a placebo (P = .0009), and 22% of those on the drug achieved HiSCR100 versus 8% given a placebo (P = .001).

“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,” Nikolai Brun, Chief Medical Officer of Affibody, said in a statement. “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.”¹

Brun also commented that the new phase 3 data showed that targeting IL-17A alone with greater potency may result in achievement of the same or greater clinical responses versus agents used to target IL-17 subunits more broadly.

“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,” Bejker, Affibody’s Chief Executive Officer, concluded. “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.”¹

In the announcement, it was noted that izokibep is also being assessed in multiple late-stage studies in psoriatic arthritis, HS, and uveitis. There are top-line results from the ongoing phase 2b/3 study of izokibep use among those with uveitis which are slated for the fourth quarter of 2024.

References

1. ^{Positive phase 3 results in hidradenitis suppurativa further strengthen competitive profile of izokibep. Affibody Medical AB. August 13, 2024. https://www.affibody.se/press/positive-phase-3-results-in-hidradenitis-suppurativa-further-strengthen-competitive-profile-of-izokibep/. Date accessed: August 14, 2024.}
2. ^{ACELYRIN, INC. Announces Positive Phase 3 Data for Izokibep in Hidradenitis Suppurativa; Focuses Strategy on Lonigutamab and Reports Second Quarter 2024 Financial Results. ACELYRIN, INC. August 14, 2024. https://www.biospace.com/acelyrin-inc-announces-positive-phase-3-data-for-izokibep-in-hidradenitis-suppurativa-focuses-strategy-on-lonigutamab-and-reports-second-quarter-2024-financial-results. Date accessed: August 14, 2024.}