Apollo Therapeutics’ Anti-IL-18 Antibody Camoteskimab Met the Primary Endpoint in a Double-Blind, Randomized, Placebo-Controlled Phase 2a Clinical Trial in Atopic Dermatitis

• Patients receiving camoteskimab had a clinically meaningful and statistically significant reduction in mean EASI score at week 16 compared to placebo.
• Clear separation from placebo by week 4, demonstrating rapid onset of action.
• In the open-label phase, camoteskimab responses continued to deepen, with ~80% reduction in mean EASI score, and ~65% and ~60% responder rates for EASI-75 and IGA 0/1, respectively.
• Clinical data supports at least three-monthly dosing intervals.
• Camoteskimab was remarkably effective in all patients who had previously failed anti-IL-13/anti IL-4R (Th2 specific) biologics.
• Clinical proof of concept further confirms genetically predicted efficacy of anti-IL-18 therapy in atopic dermatitis that also exists for other indications such as IBD.

Apollo Therapeutics, the portfolio biopharmaceutical company, today announces positive results from its 32-week CHAMELEON phase 2a clinical trial of camoteskimab (an anti-IL-18 mAb that degrades IL-18 through an antibody recycling mechanism) in patients with moderate to severe atopic dermatitis (AD) conducted in the US and Canada (NCT06436183).

The double-blind, randomized, placebo-controlled trial (n=62) demonstrated clinically meaningful efficacy, achieving a statistically significant reduction in EASI (Eczema Area and Severity Index) PCFB (percentage change from baseline) at week 16 compared to placebo. EASI scores clearly separated from placebo by week 4, demonstrating rapid onset of action. Additionally, camoteskimab-treated patients demonstrated further deepening of responses in EASI and further improvement in Investigator’s Global Assessment (IGA) 0/1 and EASI-75 responder rates after week 16 and these were maintained until the end of the study at week 32.

Participants who had previously failed Th2 specific anti-IL-13/anti-IL-4 biologics all had clinically meaningful EASI and IGA responses to camoteskimab. This is consistent with the role that IL-18 has in epithelial barrier function, across multiple inflammatory pathways including Th1, Th2, Th17, and Th22.

Camoteskimab was extremely well tolerated with no treatment-related serious adverse events or discontinuations. There were no reports of conjunctivitis, mouth ulcers, or fevers.

Detailed results will be presented at a future scientific conference. Preparations are currently underway for a phase 2b dose-ranging trial in the USA, Canada, and Europe, which will test multiple subcutaneous doses and dosing regimens of camoteskimab including a three-monthly dosing regimen. 

Dr. Richard Mason FRCP, CEO of Apollo Therapeutics, said: “We are delighted with the results from the phase 2a CHAMELEON trial. Camoteskimab has demonstrated differentiation across efficacy, safety, and dosing frequency. Additionally, it has shown its class-leading potential with its differentiated ability to degrade IL-18. The efficacy of camoteskimab in patients who have previously failed anti-IL-13/anti-IL-4 biologics is also highly encouraging and highlights the importance of developing novel mechanisms of action beyond Th2-specific therapeutics for patients with atopic dermatitis. We also believe camoteskimab has the potential to be disease modifying. We look forward to starting the phase 2b dose-ranging trial as quickly as possible.”

Prof. Jonathan Silverberg, MD, PhD, MPH Professor of Dermatology at George Washington University School of Medicine and Health Sciences added “The phase 2a data for camoteskimab is exciting, demonstrating strong efficacy, a clean safety profile and the potential of at least a three-monthly dosing interval. There remains a clear need for more effective and patient-friendly treatment options for atopic dermatitis and I’m optimistic that camoteskimab has the potential to fulfil that need.”

Prof. Emma Guttman-Yassky, MD, PhD, Waldman Professor and System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai added “This is a very exciting clinical study, it shows clear differentiation, and it is great to see responses in patients who are refractory to Th2 mechanisms.”

Prof. Alan Irvine, MD Professor of Dermatology in Trinity College Dublin, Consultant Dermatologist in Children’s Health Ireland (CHI) and at St James’s Hospital, Dublin added “This data confirms that IL-18 is a highly potent cytokine that plays an important differentiated role in atopic dermatitis and that camoteskimab is a highly promising therapeutic.”