HK inno.N recently announced on the 17th that it has received approval from the Ministry of Food and Drug Safety for the clinical phase 2 trial plan (IND) of a new candidate drug for autoimmune diseases.
The company is developing the autoimmune disease new candidate drug "IN-115314" as a treatment for mild to moderate atopic dermatitis. Atopic dermatitis is a chronic inflammatory skin disease that affects approximately 3-7% of adults worldwide. In Korea, about 970,000 patients received treatment for atopic dermatitis in 2023.
"IN-115314" is a drug that blocks Janus kinases (JAK), proteins related to immune and inflammatory responses. It acts locally on the inflamed area and, according to the company, is expected to have a lower risk of side effects due to less systemic absorption compared to existing drugs. "IN-115314" is being developed as a topical formulation (ointment) which is the first of its kind in the JAK-1 inhibitor category in Korea.
HK inno.N reported that "IN-115314" showed excellent treatment effects for atopic dermatitis compared to the control drug in the phase 1 clinical trial completed last December, confirming its safety, tolerability, and pharmacokinetic properties. The approved phase 2 trial from the Ministry of Food and Drug Safety will assess the appropriate dosage in adult patients with atopic dermatitis.
Existing topical treatments for atopic dermatitis include corticosteroids, calcineurin inhibitors, and PDE4 enzyme inhibitors that cause inflammatory responses, which are either in use or under development. However, these treatments are noted for their difficulty in being used long-term or causing a burning sensation upon application.
HK inno.N is researching JAK inhibitor class new treatments for atopic dermatitis for both humans and animals. The veterinary medicine is being developed in oral form and has applied to the Ministry of Food and Drug Safety for a clinical phase 3 trial plan.
A representative from HK inno.N noted that "the competing drugs currently sold overseas recorded sales of $508 million (730 billion won) in just last year, a 50% growth from the previous year, indicating a high demand for JAK inhibitors," and added, "there is an increasing need to develop topical formulations as alternatives to overcome the limitations of safety and efficacy of existing oral treatments."