HK inno.N Announces Phase 1 Clinical Results for New Atopic Dermatitis Drug at European Academy of Dermatology and Venereology

Eczema Severity Reduced by Up to 78% After Four Weeks of Treatment

HK inno.N announced on the 22nd that it presented the results of Phase 1 clinical trials for its new atopic dermatitis drug, IN-115314, at the 2025 European Academy of Dermatology and Venereology (EADV 2025), held in Paris, France, from September 17 to 20 (local time).

In this study, after four weeks of applying the IN-115314 ointment, the Eczema Area and Severity Index (EASI) score was reduced by up to 77.8%. Systemic exposure was only one-twentieth that of competing drugs, demonstrating both efficacy and safety.

IN-115314 is a Janus kinase-1 (JAK-1) inhibitor and a new drug candidate for atopic dermatitis. HK inno.N is simultaneously developing a topical ointment for humans and an oral formulation for animals.

This announcement covers the first Phase 1 clinical trial in which the ointment was administered to humans. Phase 1 was conducted in two parts. The first part evaluated the safety and tolerability of single and repeated doses in healthy adult males at various dosages. The second part assessed the safety and tolerability of IN-115314 ointment (1% and 3%) or a comparator drug (pimecrolimus ointment) applied twice daily for four weeks in adults with mild to moderate atopic dermatitis, and also explored its efficacy.

Among adults with mild to moderate atopic dermatitis, the EASI scores in all IN-115314 ointment dosage groups showed a significant reduction from baseline as early as the first week of application. By the fourth week, the average reduction rate reached up to 77.8%, demonstrating superior results compared to the comparator drug.

Additionally, statistically significant improvements from baseline were observed in the Investigator’s Global Assessment (IGA), Numeric Rating Scale (NRS) for pruritus, and Dermatology Life Quality Index (DLQI) scores.

In the safety and tolerability assessment, no adverse events were observed due to increased dosage or repeated administration of IN-115314 ointment. Notably, major side effects associated with JAK inhibitors, such as decreased absolute neutrophil count and reactivation of herpes zoster, were not reported.

Furthermore, when comparing the minimum blood concentration at steady state, the competing drug in the same class reached up to 20% of the IC50 (the concentration required to inhibit 50% of JAK receptor activity), whereas IN-115314 ointment reached only 1.2%. This indicates a significantly lower risk of systemic side effects.

An HK inno.N representative stated, "IN-115314 ointment is expected to overcome the safety and efficacy limitations of existing topical treatments for atopic dermatitis and provide patients with a wider range of therapeutic options. Currently, Phase 2 clinical trials are underway at 12 sites in Korea with 162 patients to determine the optimal dosage, and preparations are being made for clinical trials in the United States to expand into the global market."

The European Academy of Dermatology and Venereology is the largest dermatology conference in Europe and celebrated its 34th edition this year. With 17,000 participants, mainly dermatology professionals, it is recognized for its scale and influence in the field.

This content was produced with the assistance of AI translation services.