Alphyn Gains FDA Clearance for Atopic Dermatitis Drug Trial

Alphyn Biologics, a dermatology-focused company at the clinical stage, has announced that the U.S. Food and Drug Administration (FDA) has granted clearance for the Investigational New Drug Application (IND) for their innovative product, Zabalafin Hydrogel. This new treatment is aimed at addressing mild to moderate cases of atopic dermatitis, marking a significant milestone in dermatological therapeutics.

Zabalafin Hydrogel stands out due to its ability to tackle all major issues associated with atopic dermatitis. Unlike existing treatments, it targets the bacterial cause of the condition, alleviates pruritus (itching), and addresses the immuno-inflammatory processes involved in the disease. This comprehensive approach is expected to offer substantial relief for patients, enhancing their overall quality of life.

Neal Koller, CEO of Alphyn, highlighted the significance of this development, emphasizing the company's dedication to delivering a groundbreaking treatment for a widespread condition that affects numerous individuals. He expressed confidence that Zabalafin Hydrogel represents a pivotal advancement in the treatment of atopic dermatitis. The product promises excellent patient tolerability, making it a suitable option for long-term, continuous use without concerns. It aims to provide comprehensive management of itch, inflammation, and the bacterial imbalances on the skin that often worsen the condition and trigger flare-ups.

Zabalafin Hydrogel is categorized as a novel, first-in-class complex botanical drug. It contains multiple bioactive compounds which offer various therapeutic actions including anti-pruritic, antibacterial, and anti-inflammatory effects. This multi-target approach has demonstrated remarkable success in Phase 2a clinical trials, achieving all primary and secondary goals. The trials reported significant improvements in itch relief, patient-reported quality-of-life measures, and inflammation reduction, all while ensuring safety and minimal side effects. Patient tolerability was notably strong, reinforcing the product's promise.

The hydrogel is developed from Alphyn's proprietary Zabalafin Platform, which is designed for creating multi-target therapeutics. Alphyn Biologics plans to initiate global Phase 2b trials of Zabalafin Hydrogel in the early months of 2025, further advancing its potential as a key treatment in dermatology.

Alphyn Biologics is a company specializing in the development of pioneering Multi-Target Therapeutics for serious skin diseases. Founded in 2020, the company is headquartered in Annapolis, Maryland, and Cincinnati, Ohio, with subsidiaries in Australia and Austria. It has raised approximately $17 million to support its projects. The lead product from its Zabalafin Platform, Zabalafin Hydrogel, is being developed as a topical solution for atopic dermatitis, the most prevalent form of eczema.

The innovative Zabalafin Hydrogel has shown significant efficacy and safety in early clinical trials, indicating its potential as the first all-encompassing treatment for atopic dermatitis. Its ability to effectively address all aspects of the disease—bacterial, pruritic, and inflammatory—positions it as a promising solution for patients requiring long-term, continuous care. The Zabalafin Platform's unique composition, with multiple bioactive compounds, underpins a robust pipeline of dermatological therapies anticipated to offer advantages in efficacy, safety, side effects, patient tolerability, and regulatory approval.