Promising Phase 2 Data on Septa-Specific Monoclonal Antibody for Hidradenitis Suppurativa

Article

New late-breaking data showed positive results from the phase 2 trial on a novel septa-specific monoclonal antibody for HS patients.

Seth Forman, MD

Credit: forecaremed.com

Seth Forman, MD

Credit: forecaremed.com

Late-breaking data presented at the the American Academy of Dermatology (AAD) 2023 Annual Meeting in New Orleans indicated promising results for the use of a novel septa-specific monoclonal antibody—LY3041658 (LY)—for patients with hidradenitis suppurativa (HS).1

The investigators found that the percentage reduction from baseline in inflammatory nodules and total abscesses at 16 weeks was 52.1% for those given LY and 14.5% for the placebo group.

The investigators found that the HiSCR50 at week 16 was 65.6% for HS patients given LY, 32.3% for patients given augmented placebo, and 41.4% for patients given non-augmented placebo.

They noted that 81.8% of the study participants who had been randomized to LY that achieved Hidradenitis Suppurativa Clinical Response (HiSCR50) at 16 weeks maintained HiSCR50 by Week 36.

The chemokine receptors CXCR1 and CXCR2 are known to play a role in neutrophil migration to areas of inflammation, and LY binds to an epitope that is shared by the 7 human ligands of CXCR1 and CXCR2.

In vitro studies had shown that LY inhibited neutrophil chemotaxis but that it did not inhibit their effector functions, so the investigators conducted this phase 2 study for adults with moderate-to-severe HS.

The investigators randomized participants 2 to 1, having them receive 600 mg of LY or the intravenous placebo once every 2 weeks for 16 total weeks. This was then followed by LY 600 mg for every 2 weeks up until the end of 20 additional weeks.

The primary endpoint was the percentage of patients with a HiSCR50 at week 16, with a prespecified analysis augmented by patient-matched placebo data from previous phase 3 HS trials.

HS is a chronic, inflammatory skin disorder that can be debilitating and is known to regularly require surgical intervention, depending on the level of severity.

The only US Food and Drug Administration-approved drug for HS treatment today is adalimumab, a monoclonal antibody targeting TNF-α.2

References

  1. Forman S, et al. Safety and Efficacy of LY3041658, a Novel Septa-Specific Monoclonal Antibody to CXCR1 and CXCR2 Ligands, in a Phase 2 Study in Hidradenitis Suppurativa. Paper presented at: American Academy of Dermatology 2023 Annual Meeting; March 17-21, 2023. New Orleans, LA. Accessed March 18, 2023.
  2. AbbVie's HUMIRA® (adalimumab) Receives First and Only U.S. Food and Drug Administration Approval for Moderate to Severe Hidradenitis Suppurativa. PR Newswire. 2015 Sep 10 [cited 2023 Mar 18]. Available from: https://www.prnewswire.com/news-releases/abbvies-humira-adalimumab-receives-first-and-only-us-food-and-drug-administration-approval-for-moderate-to-severe-hidradenitis-suppurativa-300141140.html.

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