ANNAPOLIS, Md., Aug. 20, 2024 /PRNewswire/ -- Alphyn, a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics®, announced today that it has received a notice of claims allowance from the U.S. Patent and Trademark Office (USPTO) covering compositions and methods of use for the drug formulation of Zabalafin Hydrogel (AB-101a) for atopic dermatitis. Once issued, the patent will cover Zabalafin Hydrogel through 2042 and will be eligible for listing in the FDA's Orange Book providing additional protection benefits once Zabalafin Hydrogel is approved by the FDA.
Zabalafin Hydrogel is Alphyn's lead product candidate and is being developed as the first therapeutic for AD to directly treat AD's itch, directly treat bacteria that are increasingly thought to cause AD's inflammation and flares and cause infected AD skin and directly treat AD's inflammation. Zabalafin Hydrogel is a novel, first-in-class complex single-source botanical drug with multiple bioactive compounds that provide multiple mechanisms of action, including anti-pruritic (anti-itch), antibacterial, and anti-inflammatory activity. The topical is derived from the company's Zabalafin Platform.
"Zabalafin Hydrogel holds great promise as the first complete treatment for AD to directly tackle all the components that cause and worsen the disease," said Alphyn CEO Neal Koller. "We believe this allowance and the resulting patent would provide broad protection of this novel drug, as we aggressively build our intellectual property portfolio for both Zabalafin Hydrogel and our Zabalafin Platform globally."
Zabalafin Hydrogel completed Phase 2a clinical trials in 2024, demonstrating that it is highly effective in treating AD's itch, and improving patients' quality of life with limited side effects and strong patient tolerability. The results indicate the potential of Zabalafin Hydrogel to be the "drug of choice" for patients ages 2 and older, as the first worry-free AD therapeutic for long-term continuous use. Alphyn anticipates Phase 2b trials will begin in the U.S., Europe, and Australia in 2025.
ABOUT ALPHYN BIOLOGICS
Alphyn Biologics is a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics® for severe and prevalent skin diseases based on its Zabalafin Platform. Its lead product candidate, Zabalafin Hydrogel, is being developed as a topical treatment for atopic dermatitis (AD), the most common form of eczema. Zabalafin Hydrogel has demonstrated efficacy in Phase 2a clinical trials, and the company believes it will be the first AD drug to directly treat AD's itch, directly treat bacteria that are increasingly thought to cause AD's inflammation and flares and cause infected AD skin and directly treat AD's inflammation. Clinical trial results of Zabalafin Hydrogel suggest it has the potential to be the first AD treatment that is worry-free for long-term, continuous use.
Alphyn's Zabalafin Platform has multiple bioactive compounds and, therefore, multiple mechanisms of action to support a robust pipeline of dermatologic therapeutics that have potential safety, side effect, patient tolerability, efficacy, and regulatory marketing authorization advantages. Alphyn is based in Annapolis, Maryland, and Cincinnati, Ohio, and has wholly-owned subsidiaries in Australia and Austria. The company became operational in 2020 and has raised approximately US$16 million.
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