La Paz Applies for IND of Microneedle Allergy Immunotherapy... "Will Expand Application of Vaccine Platforms like mRNA"

[Asia Economy Reporter Yoo Hyun-seok] Lapas, a company specializing in the development of microneedle patch pharmaceuticals, announced on the 24th that it has completed the submission of an Investigational New Drug (IND) application to the Korea Food and Drug Administration (KFDA) for ‘DF19001,’ an allergy immunotherapy under development for allergic rhinitis.

Lapas plans to verify the safety and efficacy of the immunotherapy microneedle patch in patients with allergic rhinitis through clinical trials.

Lapas’s allergy immunotherapy ‘DF19001’ is a microneedle patch containing highly purified extracted allergens that trigger allergies. By exposing allergy patients to small amounts of allergens over a certain period, it reduces allergic reactions in the body and induces immune tolerance, enabling fundamental treatment.

Conventional allergic rhinitis treatments mainly involve ‘avoidance therapy’ to prevent contact with allergens and drug therapies such as ‘antihistamines’ and ‘steroids’ to alleviate symptoms. Since these are palliative treatments rather than fundamental cures, the possibility of symptom recurrence due to seasonal and environmental changes has been pointed out as a drawback.

Lapas’s microneedle patch technology delivers antigens through the skin, similar to vaccines. Unlike regular patches, it can deliver polymer antigens. The immunotherapy microneedle patch is sometimes referred to overseas as an ‘allergy vaccine.’

In comparative experiments with conventional subcutaneous injection immunotherapies, Lapas’s needle patch demonstrated superior efficacy. The company explained that their patch, with a drug dose ten times lower than conventional injections, showed the same immune activation effect in tests using allergic animal models.

A Lapas official stated, “Currently, immunotherapy is the only fundamental treatment for allergies, but existing injectable immunotherapies carry risks of side effects such as anaphylactic shock and the inconvenience of having to visit hospitals for each administration. Lapas’s microneedle patch not only has a lower risk of side effects but can also be self-applied by patients, making it a product with high convenience and cost-effectiveness. It is attracting significant interest from pharmaceutical companies both domestically and internationally.”

He added, “With this clinical trial as a milestone, we will actively expand our business into the immunotherapy field and become a new leader in the global immunotherapy market. Based on microneedle patch technology loaded with antigens, we will accelerate the development of various products, including tuberculosis vaccines, polio, and nucleic acid (DNA, mRNA)-based vaccine platforms currently under development, advancing to the next level as a specialized microneedle patch pharmaceutical company.”

Lapas plans to conduct additional clinical studies in the future, form partnerships with global pharmaceutical companies, and carry out global clinical trials in North America and Europe, regions with high incidence rates of allergy patients.