zabalafin hydrogel (AB-101a) / Alphyn Biologics - LARVOL DELTA

Phase 2b Trial of Zabalafin Hydrogel, A Novel Topical Botanical Drug That Addresses The Four Demons of Atopic Dermatitis (ISAD-RAJKA 2025) - "If the trend holds on unblinding, the results parallel what was seen in Phase 2a, where efficacy/safety was demonstrated for all endpoints regardless of initial infection status. These findings continue to demonstrate the potential for zabalafin as a single comprehensive topical approach for mild to moderate AD management regardless of infection status."

P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Inflammation • Pruritus

Alphyn…announced today that the U.S. Patent and Trademark Office (USPTO) has granted a patent for the active pharmaceutical ingredient (API) in its lead candidate for atopic dermatitis (AD) (PRNewswire) - "This new patent covers the topical use of Alphyn's drug raw material for the effective treatment of atopic dermatitis and provides protection until 2041. It supplements the company's U.S. Zabalafin Hydrogel patent that provides protection to 2043."

Patent • Atopic Dermatitis

Zabalafin Hydrogel, A Novel Safe and Effective Topical Botanical Drug That Comprehensively Addresses The Four Demons of Atopic Dermatitis (EADV 2025) - "These findings demonstrate the potential for zabalafin as a singular comprehensive topical approach for AD management that targets the four demons of AD."

Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Pruritus

The Atopic Dermatitis Continuum: An Updated Paradigm for a Common Disorder and a Novel Multipurpose Treatment Option. (PubMed, J Drugs Dermatol) - "Recognizing AD as a Continuum emphasizes the necessity for multi-targeted therapeutic strategies. By addressing the interconnected processes of inflammation, infection, pruritus, and xerosis within the AD Continuum, zabalafin offers a promising therapeutic option for sustained disease control."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Inflammation • Pruritus

Practical Algorithm on Topical Treatment of Flaring Atopic Dermatitis (AD) With or Without Secondary Infection. (PubMed, J Drugs Dermatol) - "2025;24(6):621-630. doi:10.36849/JDD.8967."

Journal • Review • Atopic Dermatitis • CNS Disorders • Depression • Dermatitis • Dermatology • Immunology • Infectious Disease • Inflammation • Mood Disorders • Pediatrics • Psychiatry

Alphyn Doses First Patients in CLEAR-AD1 Global Phase 2b Clinical Trial Program for Atopic Dermatitis (PRNewswire) - "Alphyn GmbH...announced today that it has initiated its CLEAR-AD1 Phase 2b clinical trial of Zabalafin Hydrogel in Australia and has dosed the first 8 patients. The company anticipates expanding the trial to sites in Europe and the United States later this year."

Trial status • Atopic Dermatitis

Alphyn Announces First Patient Dosed in CLEAR-AD1 Global Phase 2b Clinical Trial Program of Zabalafin Hydrogel for Atopic Dermatitis (PRNewswire) - "Alphyn...announced today that the first patient has been dosed in its CLEAR-AD1 Phase 2b clinical trial of Zabalafin Hydrogel in Australia. The trial will evaluate the safety, efficacy, and tolerability of Zabalafin Hydrogel in patients with mild and moderate atopic dermatitis (AD) and directly treat the immuno-inflammatory and bacterial causes of the disease at all stages, from AD onset to infection....The company anticipates initiating clinical trials in the U.S. and in Europe later this year."

New trial • Trial status • Atopic Dermatitis

Alphyn Poster at American Academy of Dermatology Annual Meeting Highlights Potential of Zabalafin Hydrogel as Singular, Comprehensive Treatment for Atopic Dermatitis (PRNewswire) - P2a | N=72 | CLEAR-AD1 (NCT06855745) | Sponsor: Alphyn Biologics | "Alphyn...announced today a poster presentation on Zabalafin Hydrogel at the American Academy of Dermatology (AAD) annual meeting demonstrating the topical therapeutic's potential as a singular comprehensive approach to effectively managing the itch, bacterial cause, and immuno-inflammatory cause of atopic dermatitis (AD) and its progression...Results showed strong improvement in itch with Pruritus Numerical Rating Scale (NRS) reduction of greater than 4 in 68 percent of patients by end of treatment, and excellent quality of life improvement, as shown in the Patient Oriented Eczema Measurement scale (POEM) of greater than 6 in 89 percent of patients. Clinically relevant reduction in inflammation was demonstrated using Investigator Global Assessment, or IGA, with 50 percent of patients achieving an IGA of clear/almost clear and greater than 2 improvement at 12 weeks."

P2a data • Atopic Dermatitis

CLEAR-AD1: Phase 2 Randomized Double-blind Study to Assess Topical Zabalafin Hydrogel Vs Vehicle in Mild to Moderate AD. (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: Alphyn Biologics

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Alphyn Secures FDA Clearance of Investigational New Drug Application for Atopic Dermatitis Treatment (PRNewswire) - "Alphyn...announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for Zabalafin Hydrogel for the treatment of mild to moderate atopic dermatitis. Zabalafin Hydrogel is unique in its ability to directly treat all the problems of AD, specifically directly treating the bacterial cause of AD, directly treating AD's pruritus (itch), and directly treating the immuno-inflammatory cause of the disease....Alphyn anticipates the initiation of the global Phase 2b trials of Zabalafin Hydrogel in the first quarter of 2025."

IND • New P2b trial • Atopic Dermatitis

Alphyn Granted U.S. Patent Covering First-in-Class Treatment for Atopic Dermatitis (PRNewswire) - "Alphyn...announced today that the U.S. Patent and Trademark Office (USPTO) has granted the company a patent covering compositions and methods of use for the drug formulation of Zabalafin Hydrogel (AB-101a) for atopic dermatitis (AD). The patent covers Zabalafin Hydrogel through 2042 and is eligible for listing in the U.S. Food and Drug Administration's (FDA) Orange Book, which provides additional protective benefits once Zabalafin Hydrogel receives FDA approval....The company expects to begin Phase 2b clinical trials of Zabalafin Hydrogel in the United States, Europe, and Australia in the first half of 2025."

New P2b trial • Patent • Atopic Dermatitis

Itch Reduction and Quality of Life Improvement in AD for First Human Use of Zabalfin (EADV 2024) - "These results for zabalafin suggest its capability to be an effective treatment of both non-infected AD and AD with secondary bacterial infection. Zabalafin demonstrated clinically meaningful results in pediatric and adult populations for itch and QOL improvement. Zabalafin is a promising unique topical AD drug for children and adults with the potential for limitless long-term continuous use."

HEOR • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Pain • Pediatrics • Pruritus

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 – Itch and Quality of Life Interim Results (EADV 2024) - "These results for zabalafin suggest its capability to be an effective treatment of both non-infected AD and AD with secondary bacterial infection. Zabalafin demonstrated clinically meaningful results in pediatric and adult populations for itch and QOL improvement. Zabalafin is a promising unique topical AD drug for children and adults with the potential for limitless long-term continuous use."

Clinical • HEOR • P1 data • P2 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Pain • Pediatrics • Pruritus

Alphyn Receives Notice of Claims Allowance for U.S. Patent Covering Zabalafin Hydrogel (PRNewswire) - "Alphyn...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."

Patent • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Study of topical AB-101 hydrogel versus vehicle in participants with atopic dermatitis. (ANZCTR) - P2 | N=72 | Completed | Sponsor: Alphyn Biologics Australia Pty. Ltd., a subsidiary of Alphyn Biologics, LLC | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease

Alphyn Biologics Reports Positive Results from First Cohort of Phase 2a Trial of Mild-to-Moderate Atopic Dermatitis Treatment (PRNewswire) - "Alphyn Biologics...announced today positive results from the first cohort of its Phase 2a clinical trial of AB-101a, a topical therapeutic for mild-to-moderate atopic dermatitis (AD). The trial met all of its primary endpoints, highlighting AB-101a's potential to be an effective and safe treatment for AD. The randomized, vehicle-controlled, double-blind trial is evaluating the treatment protocol of AB-101a across multiple sites using standard scales for assessing AD. The trial, conducted in Australia, enrolled 41 AD patients, and treatment was evaluated after four weeks....'We are excited by these results and look forward to the results of our ongoing cohort treating infected AD. We plan to further study AB-101a in a Phase 2b/3 trial next year in conjunction with a Series B financing'....Alphyn intends to present the full results of this trial at a scientific conference and submit a paper for publication in a peer-reviewed journal."

New P2/3 trial • P2a data • Atopic Dermatitis • Dermatology • Immunology

Alphyn Biologics: Passed the halfway point of the trial for the treatment of mild to moderate atopic dermatitis [Google Translation] (PRNewswire) - "Alphyn Biologics...announced enrollment in its Phase 2a clinical trial of AB-101a for mild to moderate atopic dermatitis (AD) it has passed the midpoint. The randomized, double-blind, vehicle-controlled trial is evaluating AB-101a for the treatment of AD in adults and children, 2 years of age and older, and exclusively includes a subset of patients with commonly reported bacterial infections. associated with the disease."

Enrollment status • Atopic Dermatitis • Dermatology • Immunology