Daewoong Pharmaceutical Applies for Approval of Korea's First JAK3 Inhibitor New Drug for Canine Atopic Dermatitis

Independently Discovered Small-Molecule Drug
Selected Project for Ministry of Agriculture Technology Development Program

Daewoong Pharmaceutical announced on January 14 that it had applied for product approval for an atopic dermatitis treatment for dogs containing the active ingredient 'flodicitinib' to the Animal and Plant Quarantine Agency on December 24.

Daewoong Pharmaceutical Yongin Research Center, Yongin-si, Gyeonggi Province. Daewoong Pharmaceutical

This product is an example of Daewoong Pharmaceutical developing its independently discovered small-molecule new drug substance, 'flodicitinib,' into a veterinary medicine exclusively for companion animals. Its safety and efficacy have been verified through non-clinical and clinical studies that meet international standards.

Flodicitinib is the first JAK inhibitor-based atopic dermatitis treatment for dogs developed in Korea. After completing Phase 2 clinical trials in 2023, the company entered Phase 3 the following year and successfully concluded Phase 3 at the end of last year. Currently, a Phase 1 clinical trial for a human medicine using the same ingredient is also underway.

JAK inhibitors are treatments that alleviate itching and skin inflammation by blocking inflammatory signaling pathways that cause atopic dermatitis. Flodicitinib is evaluated as a promising candidate because it selectively modulates JAK3, which is closely associated with skin diseases, while also inhibiting other pathways that excessively amplify immune responses, thereby increasing efficacy and reducing the risk of side effects.

According to the results of the Phase 3 clinical trial, flodicitinib showed improvement in lesions from the second week of administration. The CADESI index, which evaluates the extent and severity of skin lesions, decreased from 56 to 44, and by the final administration point at 12 weeks, it improved further to 35. For severe cases (CADESI index of 60 or higher), the treatment effect was superior compared to the control drug.

It was also effective in dogs that did not respond to or had developed resistance to existing treatments. Existing JAK inhibitors are known to lose effectiveness or induce resistance in about one-third of all users. Flodicitinib is also expected to fundamentally improve the underlying causes of atopic dermatitis. Canine atopic dermatitis is a condition in which increased levels of the immune substance IgE lead to recurrent itching and inflammation. In the group administered flodicitinib, IgE levels decreased by more than 30% compared to the control drug.

Park Sungsoo, CEO of Daewoong Pharmaceutical, stated, "Flodicitinib was selected in 2022 as a project for the Ministry of Agriculture, Food and Rural Affairs' full-cycle industrialization technology development program for companion animals. It is a drug that can provide a meaningful treatment alternative in areas where existing veterinary JAK inhibitors have not been effective. We will continue to expand indications utilizing the JAK inhibitor mechanism, including for autoimmune skin diseases."

Meanwhile, following the application for product approval of 'Enblopet' in October last year, Daewoong Pharmaceutical plans to secure new growth engines in the veterinary medicine market based on its differentiated technology and research and development capabilities through the development of flodicitinib.