DBV Technologies Progresses Peanut Allergy Study for Toddlers

DBV Technologies Takes Significant Steps in Peanut Allergy Research

DBV Technologies, a leader in clinical-stage biopharmaceutical development, has announced an important milestone in its COMFORT Toddlers supplemental safety study. The company is focused on addressing the critical needs of peanut-allergic toddlers between the ages of 1 to 3 years. This pivotal study will utilize the Viaskin® Peanut patch, marking a promising development in food allergy treatments.

Overview of the COMFORT Toddlers Study

On this journey towards innovation, the first subject has been screened at the Respiratory Medicine Research Institute of Michigan, with Dr. Jeffrey Leflein overseeing the process as Principal Investigator. With additional study sites activated, including the Allergy and Asthma Center of Minnesota and the Hamilton Allergy and Immunology Clinic in Ontario, Canada, screenings are now underway.

Importance of the Study Design

The COMFORT Toddlers study is set to enroll around 480 participants across 80 to 90 sites in multiple regions, including the U.S., Canada, Australia, the UK, and Europe. This Phase 3 double-blind, placebo-controlled trial aims to reinforce the data gathered from the earlier EPITOPE study while providing further insights into the Viaskin Peanut patch's safety and efficacy in young children.

Expert Insights and Commitment

Dr. Leflein expressed his enthusiasm about being the first to screen a participant for this important trial. He emphasized the significance of this milestone for peanut-allergic children and their families, noting that the aim is to generate critical data to potentially facilitate market entry for the Viaskin Peanut patch.

Collaboration Among Investigators

Dr. Julie Wang, another key figure in the study and a professor at the Icahn School of Medicine, echoed this sentiment, highlighting the high demand for effective treatments for this vulnerable population. The collaboration among clinicians is essential for the successful execution of the trial.

Future Implications of the Study

According to Daniel Tassé, CEO of DBV Technologies, initiating subject screening stands as a crucial advancement in developing groundbreaking therapies for food allergies. He expressed confidence that the data produced from the COMFORT Toddlers study will be pivotal for a Biologics License Application (BLA) submission to regulatory authorities. The company remains dedicated to the development of the Viaskin Peanut technology, affirming its commitment to patients in need.

Projected Timeline and Goals

This ambitious study aims to support a BLA submission anticipated to occur in the second half of 2026, facilitating an expedited approval process aligned with the Accelerated Approval Pathway. This pathway is designed for promising therapies that address unmet medical needs, particularly for conditions as critical as food allergies.

Investor Engagement and Communication

DBV Technologies recognizes the importance of transparency and engagement with its investors. On the day of the announcement, the management team hosted an investor conference call and webcast to detail the latest updates on the COMFORT Toddlers study and its implications for future developments. Investors were invited to join via dedicated teleconferencing numbers, highlighting the company's ongoing commitment to open communication.

About DBV Technologies

DBV Technologies is centered on pioneering therapeutic options for food allergies and other significant immunological conditions. By leveraging its proprietary VIASKIN® technology, the company is leading advancements in the field of food allergy treatment through innovative methods such as epicutaneous immunotherapy (EPIT™). This non-invasive approach aims to retrain the immune system to tolerate allergens, reducing the severity of allergic reactions and improving the quality of life for affected individuals.

Conclusion

With a focus on improving the lives of those with food allergies, DBV Technologies is actively paving the way for advancements in treatment options through dedicated clinical trials and innovative therapies. The ongoing work in the COMFORT Toddlers study is a testament to the company’s commitment to its mission and the families it serves.

Frequently Asked Questions

What is the purpose of the COMFORT Toddlers study?

The study aims to evaluate the safety and efficacy of the Viaskin Peanut patch in peanut-allergic toddlers aged 1-3 years.

How many participants will be enrolled in the study?

Approximately 480 subjects are expected to be enrolled across multiple study sites globally.

Who is overseeing the subject screening for the study?

Dr. Jeffrey Leflein acts as the Principal Investigator at the Respiratory Medicine Research Institute of Michigan.

What is the anticipated timeline for the study's data submission?

The submission of data for a Biologics License Application is anticipated in the second half of 2026.

What technology does DBV use in its treatment approaches?

DBV Technologies employs its proprietary VIASKIN® patch technology to deliver treatment through the skin.

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