La Paz Receives Approval for Phase 1 Clinical Trial Plan of Microneedle Patch for Alzheimer-Type Dementia

[Asia Economy Reporter Hyunseok Yoo] Lapass announced on the 26th that the Ministry of Food and Drug Safety approved the clinical phase 1 plan (Investigational New Drug Application, IND) for the dementia treatment patch BR4002, which delivers donepezil through microneedles, on the 22nd. Lapass is developing this jointly with Boryung Pharmaceutical.

This is the first approval for a clinical phase 1 trial of a donepezil patch using a microarray patch method both domestically and internationally. It is the second IND approval for a microneedle patch developed by Lapass. Following the PTH microarray patch approved on March 18, clinical trials are expected to commence soon.

There are various technologies for transdermal drug delivery systems (TDDS) that deliver drugs through the skin. However, Lapass’s microneedle patch is a novel drug delivery technology that uses extremely fine needles on a patch attached to the skin to deliver drugs, active ingredients, or vaccines directly into the body without pain.

This clinical trial will be conducted at Inha University Hospital and is a randomized, open-label, single-dose, crossover clinical trial to compare and evaluate the pharmacokinetic characteristics, safety, and tolerability of BR4002 and BR4002-1 in healthy adult volunteers.

Lapass’s donepezil microarray patch is a ‘microarray transdermal absorption system’ that differs from patches by companies such as iQure and Dong-A ST, which are conducting clinical trials with the same drug. The microarray patch contains micrometer-sized microprotrusions (microarrays) loaded with the drug. Unlike conventional patches, it maximizes the delivery rate of active ingredients of large molecular weight and hydrophilic drugs, and overcomes the drawbacks of existing patches such as skin damage caused by enhancers, making it an innovative drug delivery system.

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