No camouflaging success of Apollo Therapeutics' atopic dermatitis CHAMELEON trial
The anti-IL-18 mAb degrades IL-18 through an antibody recycling mechanism in patients with moderate to severe atopic dermatitis (AD). The trial was conducted in the US and Canada.
The double-blind, randomised, 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, Apollo reports.
EASI scores clearly separated from placebo by week four, demonstrating rapid onset of action, the company adds. Camoteskimab-treated patients also 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.
The company says that participants who had previously failed Th2 specific anti-IL-13/anti-IL-4 biologics all had clinically meaningful EASI and IGA responses to camoteskimab which, in its own words, was extremely well tolerated with no treatment-related serious adverse events or discontinuations. There were no reports of conjunctivitis, mouth ulcers, or fevers, Apollo reports.
Detailed results will be presented at a future scientific conference. Preparations are underway for a phase 2b dose-ranging trial in the US, Canada, and Europe, which will test multiple subcutaneous doses and dosing regimens of camoteskimab including a three-monthly dosing regimen.
Dr. Richard Mason, 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.”
Camoteskimab is an anti-IL-18 mAb that degrades IL-18 through an antibody recycling mechanism. It is being developed as a novel therapeutic for inflammatory indications with an initial focus on atopic dermatitis. There are multiple additional potential indications for camoteskimab including inflammatory bowel disease and asthma based on IL-18 biology, presenting true pipeline-in-a-product-potential.
Apollo is preparing a multi-centre phase 2b dose-ranging trial, to test multiple subcutaneous dose levels of camoteskimab with different dosing frequencies.
Atopic dermatitis is the most common chronic inflammatory skin disease globally, with over 204 million people (2.6 per cent of the global population) estimated to be affected. The chronic condition causes dry, itchy and inflamed skin which can have an enormous negative effect on patients’ quality of life, especially in those with moderate-to-severe disease.
While there are treatments available to manage symptoms, there is currently no cure for AD. Current biologic therapies are focused on treating Th2 driven AD, often leading to many patients either not responding or losing response to current therapies, resulting in additional unmet need.
Apollo Therapeutics translates breakthroughs in biology and basic medical research into innovative new medicines. With over 20 active therapeutic programmes, six of which are in clinical development, Apollo is building a large, diversified portfolio of novel therapeutics with uncorrelated risk.
It has a scalable R & D platform enabled by an unprecedented level of access to breakthroughs in biology and basic medical research made at six of the world’s leading universities and research institutes.
Apollo also in-licenses or acquires clinical-stage programs where it has unique insights and synergies. Backed by leading specialist health care investors, Apollo has raised over $450m since its inception.