#USA #Annapolis #Atopic Dermatitis #Zabalafin Hydrogel #Alphyn Biologics

Alphyn Biologics Begins Clinical Trials for Atopic Dermatitis Treatment

Alphyn Biologics, Inc., a company specializing in clinical dermatological research, has officially launched its global clinical Phase 2b study, known as CLEAR-AD1, involving the innovative formulation, Zabalafin Hydrogel. Taking place in Australia, the study aims to evaluate Zabalafin Hydrogel’s safety, effectiveness, and tolerability in treating mild to moderate cases of atopic dermatitis (AD). As part of its research initiative, Alphyn has already administered the treatment to the first eight patients, with plans to expand the study to sites across Europe and the USA later this year.

Atopic dermatitis, a chronic inflammatory skin condition, often involves considerable discomfort and suffering for patients due to symptoms like itching and infection. Zabalafin Hydrogel is revolutionizing the treatment landscape by directly targeting both the immune-inflammatory and bacterial causes of the disease throughout all stages—from onset to infection. This is a significant step in providing a comprehensive answer to the persistent challenges associated with AD.

Innovative Approach to Treatment

Zabalafin Hydrogel aims to combat the itch effectively and halt the immune-inflammatory pathways contributing to the progression of AD. Its innovative formula acts by targeting the bacteria involved in exacerbating AD, thus addressing the issue before it escalates to an infection. The CLEAR-AD1 study is designed to be randomized, double-blind, and vehicle-controlled to ensure robust results. Participants are categorized based on their stage in the progression of AD, assessing its efficacy both in patients where bacteria have contributed to the disease progression without yet leading to infection, and in those experiencing the later stages of infection.

Neal Koller, CEO of Alphyn Biologics, emphasizes the company's commitment to addressing the substantial patient need for a new therapeutic option that effectively and comprehensively tackles the complexities of atopic dermatitis. He states, "We are making significant strides with patient enrollment for our global clinical Phase 2b study program CLEAR-AD1. Our aim is to expand this initiative into Europe and the USA and potentially offer patients a first-of-its-kind AD medication, designed for long-term, uncomplicated usage that outperforms current therapies in effectiveness and safety."

Unveiling the Zabalafin Hydrogel

Zabalafin Hydrogel is a novel botanical-based complex drug derived from the company’s proprietary Zabalafin platform. This groundbreaking treatment features multiple bioactive compounds, harnessing various mechanisms that include anti-itch, antibacterial, and anti-inflammatory effects.

In gaining FDA approval earlier this year as an investigational product, Alphyn Biologics is diligently working toward securing regulatory authorization to initiate clinical trials in Europe. Zabalafin Hydrogel has already demonstrated significant results in two Phase 2a studies, meeting both primary and secondary endpoints: improving itch, quality of life, inflammation, and managing bacterial-associated flare-ups, even leading to skin healing in severe AD cases that had progressed to infection.

The findings have not only highlighted the impressive efficacy results but also showcased the treatment's excellent safety profile, with minimal side effects and high patient tolerance.

Recognition and Future Prospects

In November, Alphyn announced the publication of an article in the Journal of Drugs in Dermatology, which was peer-reviewed by experts and underscored Zabalafin Hydrogel’s strong efficacy and patient tolerance profile, along with its immense potential to address all facets of atopic dermatitis.

Alphyn Biologics, headquartered in Annapolis, Maryland, and Cincinnati, Ohio, has been dedicated to developing cutting-edge treatments for serious and prevalent skin conditions since its establishment in 2020, raising around 20.3 million USD to date. With its endeavors like the CLEAR-AD1 study, Alphyn is poised to make a lasting impact in the dermatological landscape and improve the lives of patients suffering from atopic dermatitis.