Camoteskimab Meets Primary Endpoint in Phase 2a Clinical Trial in Atopic Dermatitis

Patients with moderate to severe atopic dermatitis treated with camoteskimab may see clinically meaningful and statistically significant reductions in their disease by Week 16, new findings suggest.1

These new findings on camoteskimab, an investigational anti-interleukin (IL)-18 monoclonal antibody, were announced on September 16 by Apollo Therapeutics. The company reported encouraging findings from its CHAMELEON phase 2a study assessing the use of camoteskimab in atopic dermatitis (NCT06436183).

“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,” Alan Irvine, MD, professor of dermatology in Trinity College Dublin, said in a statement.1

Atopic dermatitis is a disease known to impact an estimated 204 million people worldwide, and the condition is characterized by inflamed, dry, and itchy skin that significantly impacts patients' daily lives.2 Camoteskimab, which works by degrading IL-18 via an antibody recycling mechanism, was evaluated as part of its developement as a first-in-class treatment for inflammatory conditions, with atopic dermatitis as its lead indication.

There were 62 adult patients enrolled in CHAMELEON, a randomized, double-blind, placebo-controlled trial evaluating the drug's safety and efficacy.1 CHAMELEON investigators' primary endpoint assessed was percentage change from baseline in Eczema Area and Severity Index (EASI) scores at the 12-week mark. The study remained blinded through week 16, followed by an open-label extension in which all of those taking part were treated with camoteskimab through Week 32.

The investigative team's post-hoc analyses demonstrated statistically significant improvements in patients' EASI scores at Week 16 versus placebo, with separation from placebo observed as early as the 4-week mark.1 Patient responses were noted to have deepened over time, with higher rates of EASI-75 and IGA 0/1 having been sustained through the 32-week mark. In 1 notable finding, the team observed that subjects who had failed prior anti-IL-4/IL-13 therapies also attained meaningful responses.

Camoteskimab was additionally shown to be well tolerated, with CHAMELEON investigators identitfying no treatment-related serious adverse events, drug discontinuations, or common issues such as conjunctivitis or oral ulcers among the study participants.1

“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,” Jonathan Silverberg, MD, PhD, MPH, professor of dermatology at George Washington University School of Medicine and Health Sciences, said in a statement.1 “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.”

Apollo Therapeutics is set to present the complete set of data at an upcoming conference and to initiate a phase 2b dose-ranging study in North America and Europe, including multiple subcutaneous regimens and a potential 3-monthly dosing schedule.

References

1. Apollo Therapeutics. 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. September 16, 2025. https://www.businesswire.com/news/home/20250916434001/en/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.

2. Tian J, Zhang D, Lu Q, et al. Global epidemiology of atopic dermatitis: a comprehensive systematic analysis and modelling study. Br J Dermatol. 2023 Dec 20;190(1):55-61. doi: 10.1093/bjd/ljad339. PMID: 37705227. Accessed September 16, 2025.