Plant-based topical successfully targets both inflammation, bacteria in atopic dermatitis
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Key takeaways:
- Zabalafin is a novel, first-in-class, multi-target therapeutic natural drug.
- 40% of Zabalafin-treated patients achieved a 2-point or greater IGA improvement vs. 14% of those treated with vehicle.
MIAMI BEACH, Fla. — Zabalafin, a nonsteroidal topical, demonstrated efficacy in reducing inflammation and bacteria on the skin of children and adults with atopic dermatitis, according to interim data presented in a poster at Masters of Pediatric Dermatology.
“Commercially, the market is moving towards a preference for natural products,” Neal Koller, CEO of Alphyn Biologics, told Healio, echoing the concern of many individuals surrounding the use of topical steroids for their own atopic dermatitis or that of their children.
Zabalafin hydrogel (AB-101a, Alphyn Biologics) is a novel, first-in-class, multi-target therapeutic natural drug that is being evaluated in what is the first-in-human phase 2 study. Interim data from this study showed that Zabalafin may be safe and effective in the treatment of patients aged 2 years and older with AD.
In the study, 11 total patients aged 2 to 17 years (n = 6) and 18 to 45 years (n = 5) applied Zabalafin twice daily for 8 weeks. To evaluate the efficacy of the drug against the inflammation component of AD, the researchers utilized the vehicle arms of a separate study for comparison.
After evaluations on days 8, 15, 29, 43 and 57, results showed that 40% of Zabalafin-treated patients achieved a 2-point or greater IGA score improvement, the study’s primary endpoint, vs. 14% of those treated with vehicle.
A significantly higher proportion of Zabalafin-treated patients also achieved EASI 50 (90% vs. 27%) and EASI 75 (44% vs. 0%) compared with vehicle-treated patients. A body surface area improvement of 50% was also achieved by 88% of patients treated with Zabalafin.
Only one treatment-emergent adverse event, mild transient stinging, was reported in three patients and occurred in approximately one to two study visits.
According to the study, Zabalafin not only reduced itch but also treated 100% of bacterial infections, demonstrating its success as a drug with multiple mechanisms of action.
“We are the only drug that deals with the bacterial component, meaning any flares associated with bacteria,” Koller told Healio.
“Our drug substance has multiple bioactive compounds, making it very different from every other drug, which has one,” he added. “These multiple bioactive compounds give the drug multiple mechanisms of action allowing it to target inflammation and bacteria.”
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Spelman L, et al. First in human phase 2 trial of zabalafin (AB-101): A novel topical drug candidate for mild, moderate and severe atopic dermatitis in children and adults – Interim results. Presented at: Masters of Pediatric Dermatology; Feb. 8-9, 2024; Miami Beach, Florida.
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