La Paz, Microneedle Allergy Immunotherapy Approved for Clinical Trials by MFDS

[Asia Economy Reporter Hyunseok Yoo] Lapas, a company specializing in the development of microneedle patch pharmaceuticals, announced on the 19th that it has received approval for its clinical trial plan (IND) from the Korea Food and Drug Administration (KFDA) for its allergic rhinitis immunotherapy drug ‘DF19001’.

‘DF19001,’ which recently obtained IND approval, is an improved new drug using a microneedle patch, the world’s first attempt to deliver an immunotherapy containing antigens that cause allergic rhinitis. It is also the first clinical trial drug to receive IND approval following the establishment of the KFDA’s microneedle pharmaceutical quality guidelines in February this year.

Allergy immunotherapy requires long-term administration for at least 2 to 3 years, so patient convenience in medication adherence is paramount to maintaining treatment. Lapas’s ‘DF19001’ uses a microneedle patch to reduce the risk of side effects such as anaphylactic shock and allows patients to self-apply the patch without hospital visits.

In immunotherapy using allergens, since it directly engages the immune system of allergy patients, it is expected to be effective even for patients who had difficulty being treated with conventional anti-allergy treatments.

A Lapas representative stated, “DF19001 delivers the drug through the skin layer where numerous dendritic cells and T cells involved in immune responses are distributed, enabling equal or greater therapeutic effects with smaller doses compared to existing immunotherapy injections and sublingual agents,” adding, “Its mechanism of action is similar to that of vaccine patches, so it is expected to be an important milestone in the ongoing development of microneedle patch vaccines.”

He continued, “In the global immunotherapy market, there is high expectation for new formulations suitable for long-term medication, and after clinical trials, large-scale revenue generation is anticipated through partnerships and technology transfers with global pharmaceutical companies.”