Korean pharmaceutical companies are stepping up competition to develop microneedle patch-type obesity treatments, often called “adhesive obesity drugs.”
Four companies -- Daewon Pharmaceutical, Dong-A ST, Kwangdong Pharmaceutical, and Daewoong Group – have joined the competition.
According to industry sources, Daewoong Therapeutics, an affiliate of the Daewoong Group, plans to apply for an investigational new drug (IND) application for semaglutide-based obesity treatment in the form of a microneedle patch to the Ministry of Food and Drug Safety (MFDS) next year. Semaglutide is a GLP-1 family of diabetes and obesity drug ingredients developed by Novo Nordisk.
Daewoong Therapeutics has confirmed similar pharmacokinetics (PK) to the injectable formulation at a dose 1.6 times higher than the subcutaneous (SC) formulation in preclinical studies on mice. It also has the facility to manufacture the drug for clinical trials, aiming not to exceed a patch size of 4 square centimeters.
Daewoong Therapeutics, which is developing CLOPAM (Closed-Packed Aero-pressured Microneedle), a microneedle manufacturing technology, sees a great need for microneedle-formulated anti-obesity drugs that are more convenient than existing injectable anti-obesity drugs.
Novo Nordisk has introduced an oral drug, Rybelsus. Still, the Korean company expects the microneedle patch formulation to be competitive enough because the GLP-1 analogs’ side effects, including nausea, vomiting, and diarrhea, may be more severe due to the use of excipients for peptide absorption.
In addition, the absorption rate of GLP-1 analogs is very low when taken orally. Rybelsus also has a bioavailability rate of only 1 percent, which causes low profitability due to high production costs.
If Daewoong Therapeutics enters clinical trials next year, it will spark the competition among domestic pharmaceutical companies to develop microneedle patch-type obesity drugs. So far, Daewon Pharmaceutical, Dong-A ST, and Guangdong Pharmaceutical have begun development. Their approach is to collaborate with companies with microneedle platform technology.
Microneedle patches are transdermal formulations that use micrometer-sized needles to deliver drugs. Peptide/protein medicines are degraded in the digestive system and cannot be absorbed percutaneously, so they are primarily developed for injections. However, microneedles are expected to replace traditional injection methods because they pierce the stratum corneum and deliver drugs directly to the dermis/epidermis.
Therefore, companies aim to develop improved new drugs formulated with microneedles to treat obesity. They touted the advantages of reducing pain compared to existing injections, emphasizing that the microneedle formulation produces less medical waste.
Among them, Daewon Pharmaceutical is the first to jump into clinical development. In August, Daewon submitted a phase 1 IND for DW-1022, a microneedle patch obesity treatment co-developing with Raphas, to the Ministry of Food and Drug Safety. The two companies are researching and developing a semaglutide-based obesity treatment.
Dong-A ST signed a joint R&D agreement with Zuvic to develop a microneedle-based diabetes and obesity treatment.
In April, Kwangdong Pharm announced a strategic investment of 2 billion won ($1.47 million) into QuadMedicine and signed a memorandum of understanding to cooperate in developing a microneedle patch obesity treatment.
Meanwhile, although not in the form of microneedle patches, domestic pharmaceutical companies, such as Hanmi Pharmaceutical and Ildong Pharmaceutical, are also developing GLP-1-based obesity treatments.
Last month, Ildong received phase 1 approval from the MFDS for its GLP-1 RA (receptor agonist) drug candidate, ID110521156, for metabolic diseases. After evaluating its tolerability, safety, and pharmacokinetic properties in healthy adults, the company plans to develop it as an oral drug targeting type 2 diabetes and obesity.
In July, Hanmi Pharm also drew attention by announcing that it would develop a GLP-1-based obesity drug customized for Koreans through domestic clinical trials. The strategy is to change the target indication of its metabolic disease drug candidate, efpeglenatide, to obesity and develop it into an injection administered once a week. It has submitted a phase 3 IND application to the MFDS.