- First study participant dosed in U.S. trial with healthy volunteers and patients with peanut allergy
- Novel, human-derived, half-life extended tri-specific monoclonal antibody to prevent allergic reactions
Schlieren/Zurich, Switzerland, December 11, 2025- Mabylon AG, a leader in the high-throughput discovery, engineering, and development of human-derived antibodies for the treatment of allergies, neurodegenerative diseases, and inflammation, today announced that the first healthy volunteer has been dosed in the first-in-human clinical trial evaluating MY006, a novel tri-specific monoclonal antibody for the prophylactic treatment of peanut allergy. MY006 is based on patient-derived antibodies and designed to provide a new approach for preventing allergic reactions in individuals with peanut allergy.
The ongoing study is a randomized, quadruple-blinded, placebo-controlled, single-ascending, and multiple-dose Phase 1a/b clinical trial. The study assesses the safety, local tolerability, pharmacokinetics (PK), and immunogenicity of MY006 in healthy volunteers (Part A) and peanut allergic patients (Part B) and explores the pharmacodynamics (PD) and clinical activity of MY006 in patients.
In Part A, up to 32 healthy adult volunteers (aged 18-55 years) will be enrolled across up to four cohorts to assess increasing single doses of MY006 via subcutaneous injection, followed by a multiple-dose cohort at the highest tolerated dose. Part B will enroll up to 16 adolescent and adult peanut-allergic patients (aged 12-55 years). The trial is being conducted at one early-phase clinical unit for Part A and several specialized allergy/immunology sites across the United States for Part B.
“By dosing the first participant, we are one step closer to potentially delivering a prophylactic therapy that could safeguard patients from the risks of accidental peanut exposure,” said Peter Lichtlen, Chief Medical Advisor of the Company. “We thank the clinical investigators, trial sites, and volunteers for their commitment to this groundbreaking study.”
“MY006 is a human-derived monoclonal antibody with high-affinity binding to the three major peanut allergens,” said Dr. Niccolò Pengo, PhD, Chief Scientific Officer of Mabylon. “Its tri-specific format allows for simultaneous recognition of non-overlapping epitopes across multiple allergens. This enhances broad neutralization compared to mono-specific antibodies. It has been designed for sustained serum levels, high stability and continuous protection with infrequent dosing, e.g. 2 to 4 subcutaneous injections annually. This addresses limitations of current allergy therapies requiring frequent administration.”
“The initiation of this clinical trial is an important milestone and a significant advancement of our efforts to address the unmet needs in peanut allergy management through innovative antibody engineering,” said Dr. Alcide Barberis, Chief Executive Officer of Mabylon AG. “We are very pleased about the positive IND review by the FDA and proud of becoming a clinical-stage company.”
Peanut allergy is one of the most common and potentially lethal food allergies, affecting approximately 1-2% of the population in the United States and Europe, with significant unmet medical need. MY006 is designed as a prophylactic therapy preventing allergic reactions and anaphylactic shock with only a few subcutaneous injections required per year.
About Mabylon AG
Mabylon is a Swiss biotechnology company harnessing the therapeutic potential of naturally occurring human antibodies to treat allergies, neurodegenerative diseases, and inflammation. Human-derived antibodies have superior therapeutic potential compared to antibodies derived from conventional sources, such as humanized animal models or artificial libraries. In the case of allergy, for instance, Mabylon’s antibodies derived from allergic patients target disease-relevant epitopes, expanding the knowledge of novel allergenic epitopes and their role in disease progression.
For more information, please visit www.mabylon.com
Contact
Alcide Barberis, CEO
Mabylon AG
Wagistrasse 14
8952 Schlieren (Zurich Area), Switzerland
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
Tel. +49 40 88 16 59 64 /Tel. +49 30 23 63 27 68
