Mabylon’s MY006: Phase 1 Trial for Peanut Allergy Begins

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Mabylon Doses Frist Patient in U.S. Trial of Novel Peanut Allergy Therapy

A groundbreaking clinical trial is underway to evaluate MY006, a perhaps life-changing prophylactic treatment for peanut allergy, after the first healthy volunteer received a dose in the United States.

The Swiss biotechnology company, Mabylon AG, announced on December 11, 2025, that the Phase 1a/b trial has begun, offering new hope for the millions affected by this potentially lethal food allergy. MY006 is a novel,tri-specific monoclonal antibody designed to prevent allergic reactions by targeting multiple peanut allergens concurrently.

Did you know?-Peanut allergy affects roughly 2.5 million children in the U.S., and prevalence is increasing. Early introduction of peanuts may help prevent allergy development in some infants.

Addressing a Critical Unmet Need

Peanut allergy impacts approximately 1-2% of the population in the U.S. and Europe, representing a significant public health concern. Current treatments often require strict avoidance and carry the risk of accidental exposure leading to severe, even fatal, reactions. MY006 aims to provide a more sustainable solution, potentially requiring only 2 to 4 subcutaneous injections annually for continuous protection.

Pro tip:-individuals with peanut allergies should always carry epinephrine auto-injectors and be trained in thier proper use. Review your allergy action plan regularly with your healthcare provider.

How MY006 Works: A New Approach to Allergy Prevention

Unlike customary allergy therapies, MY006 is based on patient-derived antibodies, engineered for enhanced efficacy and longevity.According to a company release, the antibodyS unique design allows it to bind to three major peanut allergens with high affinity, neutralizing them before they can trigger an immune response. “Its tri-specific format allows for simultaneous recognition of non-overlapping epitopes across multiple allergens. This enhances broad neutralization compared to mono-specific antibodies,” explained Dr. Niccolò Pengo, PhD, Chief Scientific Officer of Mabylon.

Reader question:-What factors might influence the effectiveness of MY006 in different patient populations? Further research will explore this.

Trial Design and Key Objectives

The ongoing study is a randomized, quadruple-blinded, placebo-controlled trial, designed to assess the safety, tolerability, and effectiveness of MY006. The trial is divided into two parts:

• Part A: Will enroll up to 32 healthy adult volunteers (aged 18-55 years) to evaluate increasing single doses of MY006, 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) to explore the drug’s pharmacodynamics and clinical activity.

The trial is being conducted at specialized allergy and immunology sites across the United States.

Positive Momentum and Future Outlook

The initiation of the clinical trial follows a positive Investigational New Drug (IND) review by the U.S. Food and Drug Administration (FDA), marking a significant milestone for Mabylon AG. “The initiation of this clinical trial is an crucial milestone and a significant advancement of our efforts to address the unmet needs in peanut allergy management through innovative antibody engineering,” stated Dr. Alcide Barberis, Chief Executive Officer of mabylon AG.

A senior official stated, “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.” Mabylon AG is leveraging the therapeutic