Alphyn Biologics Secures Groundbreaking Patent for Innovative Atopic Dermatitis Treatment
In a pivotal advancement for dermatological treatments, Alphyn Biologics, a clinical-stage company specializing in skin disease therapeutics, has recently been granted a U.S. patent for its novel drug formulation, Zabalafin Hydrogel (AB-101a), aimed at treating atopic dermatitis (AD). This milestone not only provides exclusive rights to the invention until 2042 but also represents a breakthrough in addressing unmet needs in treating this prevalent condition.
The Zabalafin Hydrogel is positioned to be a first-in-class therapeutic, uniquely targeting multiple aspects of atopic dermatitis. Unlike existing treatments that may focus on alleviating itch or reducing inflammation, Zabalafin Hydrogel is designed to confront the root causes of AD, particularly addressing bacterial factors believed to contribute to inflammation and flare-ups. Notably, it tackles the common bacteria Staphylococcus aureus, which can exacerbate symptoms.
CEO Neal Koller emphasized the significance of this development, stating that Zabalafin Hydrogel meets a critical need for a single topical treatment for AD by effectively reducing itch and inflammation while also being suitable for both infected and non-infected AD skin. The safety profile of this formulation has been backed by two completed Phase 2a clinical trials that showed significant improvements in itch relief, inflammation, and overall patient-reported quality of life parameters with minimal side effects. These results not only validate the efficacy of Zabalafin Hydrogel but also enhance patient tolerate, a crucial factor for long-term management.
The patent also allows for Zabalafin Hydrogel's inclusion in the FDA's Orange Book, a compilation of approved drug products that signifies additional protection and market advantages after FDA approval is granted. Looking ahead, Alphyn plans to initiate Phase 2b clinical trials in the first half of 2025 across multiple regions, including the United States, Europe, and Australia, furthering the journey to bring this promising therapy to the market.
Alphyn’s innovative approach is encapsulated in their Multi-Target Therapeutics® strategy which employs multiple bioactive compounds to create a robust pipeline of dermatologic therapies. The diverse mechanisms of action offered by Zabalafin Hydrogel not only position it as a game-changer in treating AD but also hint at the company's potential to revolutionize treatment paradigms in dermatology.
Alphyn was founded in 2020 and has since secured around $16 million in funding to support the development of their products and expand their research capabilities. The company is headquartered in Annapolis, Maryland, with additional offices in Cincinnati, Ohio, and international subsidiaries in Australia and Austria.
With the grant of this patent, Alphyn Biologics stands at the forefront of dermatological innovation, embodying a commitment to addressing complex skin disorders with novel solutions. As they move forward with clinical trials, the dermatology community and patients alike will be watching closely to see if Zabalafin Hydrogel lives up to its promise as a comprehensive treatment for atopic dermatitis.
The Zabalafin Hydrogel is positioned to be a first-in-class therapeutic, uniquely targeting multiple aspects of atopic dermatitis. Unlike existing treatments that may focus on alleviating itch or reducing inflammation, Zabalafin Hydrogel is designed to confront the root causes of AD, particularly addressing bacterial factors believed to contribute to inflammation and flare-ups. Notably, it tackles the common bacteria Staphylococcus aureus, which can exacerbate symptoms.
CEO Neal Koller emphasized the significance of this development, stating that Zabalafin Hydrogel meets a critical need for a single topical treatment for AD by effectively reducing itch and inflammation while also being suitable for both infected and non-infected AD skin. The safety profile of this formulation has been backed by two completed Phase 2a clinical trials that showed significant improvements in itch relief, inflammation, and overall patient-reported quality of life parameters with minimal side effects. These results not only validate the efficacy of Zabalafin Hydrogel but also enhance patient tolerate, a crucial factor for long-term management.
The patent also allows for Zabalafin Hydrogel's inclusion in the FDA's Orange Book, a compilation of approved drug products that signifies additional protection and market advantages after FDA approval is granted. Looking ahead, Alphyn plans to initiate Phase 2b clinical trials in the first half of 2025 across multiple regions, including the United States, Europe, and Australia, furthering the journey to bring this promising therapy to the market.
Alphyn’s innovative approach is encapsulated in their Multi-Target Therapeutics® strategy which employs multiple bioactive compounds to create a robust pipeline of dermatologic therapies. The diverse mechanisms of action offered by Zabalafin Hydrogel not only position it as a game-changer in treating AD but also hint at the company's potential to revolutionize treatment paradigms in dermatology.
Alphyn was founded in 2020 and has since secured around $16 million in funding to support the development of their products and expand their research capabilities. The company is headquartered in Annapolis, Maryland, with additional offices in Cincinnati, Ohio, and international subsidiaries in Australia and Austria.
With the grant of this patent, Alphyn Biologics stands at the forefront of dermatological innovation, embodying a commitment to addressing complex skin disorders with novel solutions. As they move forward with clinical trials, the dermatology community and patients alike will be watching closely to see if Zabalafin Hydrogel lives up to its promise as a comprehensive treatment for atopic dermatitis.
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