BOSTON– Apollo Therapeutics announced today that its anti-IL-18 antibody camoteskimab met the primary endpoint in the Phase 2a CHAMELEON trial for patients with moderate to severe atopic dermatitis, delivering statistically significant and clinically meaningful results.
The 32-week, double-blind, randomized, placebo-controlled trial (n=62) showed that patients treated with camoteskimab achieved a significant reduction in Eczema Area and Severity Index (EASI) scores at week 16 compared to placebo. Separation from placebo was observed as early as week 4, indicating a rapid onset of action.
In the open-label extension, responses deepened further, with approximately 80 percent reduction in mean EASI scores and responder rates of ~65 percent for EASI-75 and ~60 percent for Investigator’s Global Assessment (IGA) 0/1 at week 32. The data also support a dosing interval of at least three months.
Notably, camoteskimab was effective in patients who had previously failed anti-IL-13 or anti-IL-4R biologics, underscoring its potential to address refractory disease through a differentiated mechanism. The drug was well tolerated, with no treatment-related serious adverse events or discontinuations and no reports of conjunctivitis, mouth ulcers, or fever.
“We are delighted with the results from the phase 2a CHAMELEON trial,” said Dr. Richard Mason, FRCP, Chief Executive Officer of Apollo Therapeutics. “Camoteskimab has demonstrated differentiation across efficacy, safety, and dosing frequency. Its efficacy in patients who previously failed Th2-specific biologics is highly encouraging and highlights the importance of developing novel mechanisms beyond Th2-targeted therapies. We also believe camoteskimab has the potential to be disease-modifying.”
Academic experts also highlighted the significance of the findings. Prof. Jonathan Silverberg, MD, PhD, MPH, of George Washington University, said the data show “strong efficacy, a clean safety profile and the potential of at least a three-monthly dosing interval.” Prof. Emma Guttman-Yassky, MD, PhD, of the Icahn School of Medicine at Mount Sinai, described the trial as “a very exciting clinical study” that demonstrates clear differentiation, particularly in patients refractory to Th2 mechanisms. Prof. Alan Irvine, MD, of Trinity College 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.”
Detailed results will be presented at an upcoming scientific conference. Apollo is preparing to launch a Phase 2b dose-ranging trial in the United States, Canada, and Europe to test multiple subcutaneous doses and dosing regimens, including a three-monthly schedule.
