A clinical trial is underway testing a new kind of eczema treatment, developed to silence certain genes that play a role in skin inflammation. The results of a preclinical study were recently published demonstrating the experimental topical treatment reduced symptoms of dermatitis in mice.
The researchers, from Vanderbilt University Medical Center, spent a number of years developing a new kind of peptide designed to penetrate immune cells and block inflammatory signaling by silencing the activity of certain genes. Unlike other current eczema treatments, which often only partially inhibit inflammatory signaling, this new treatment broadly targets a variety of mediators of inflammation.
"We unraveled the mechanism of eczema by demonstrating that we can control at least 15 genes responsible for the production of the major mediators of skin inflammation," explained Jacek Hawiger, lead investigator on the research.
In a study published in late 2022, the researchers describe the effects of the novel treatment on animal models of atopic dermatitis. Within days of treatment with the topical cream, skin lesions had healed in the animals. The researchers also noted the experimental topical drug had no toxic effects on the animals, and skin infiltration from inflammatory cells was successfully suppressed.
A Phase 1/2 human clinical trial is already well-advanced, focusing on patients with mild to moderate atopic dermatitis. The first part of the trial is a dose escalation study, tracking the safety of increasing concentrations of the topical drug on various parts of the body.
The second part of the trial will recruit over 100 participants, split into three cohorts, each testing a different dose of the drug. The primary outcome will be looking at how effectively the topical treatment improves eczema symptoms after 28 days of use.
A biopharmaceutical company called Amytrx Therapeutics has been founded to accelerate commercial development of the new therapy. The drug has been dubbed AMTX-100, and a topical cream targeting atopic dermatitis is only the beginning of the uses being explored for this new molecule.
Alongside a cream treating a variety of skin conditions (such as psoriasis and acne), preclinical studies are underway looking at oral and injectable forms of the drug that target a variety of autoimmune conditions, including inflammatory bowel disease, arthritis and asthma. According to Amytrx CEO Matt Gonda, the drug offers an entirely new model for anti-inflammatory therapy.
“By naturally modulating a key pathway that AMTX-100 targets, which represents an internal checkpoint used to initiate inflammation, AMTX-100 has the ability to provide broad targeted therapeutic activity without affecting important housekeeping genes essential for cell growth and viability, drastically minimizing side-effects and safety concerns seen with many small molecule and biologic anti-inflammatory drugs," Gonda explained.
The new research was published in Scientific Reports.
