HK inno.N

HK inno.N Unveiling the Results of Phase 1 Clinical Trial on Its New Drug Candidate for Atopic Dermatitis at EADV 2025

Positive Efficacy Data Obtained with Up to a 77.8% Reduction in EASI at 4 Weeks of Treatment

Safety Demonstrated by Systemic Exposure Measured at only 1/20 of That of Competing Drugs

Expected to Broaden Treatment Options for Atopic Dermatitis as Korea's First Topical JAK-1 Inhibitor

Photo. HK inno.N's Poster Presentation at the '2025 European Academy of Dermatology and Venereology Congress' 

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

In this study, the Eczema Area and Severity Index (EASI) scores decreased by up to 77.8% at 4 weeks of IN-115314 ointment application, with systemic exposure being only 1/20 of that of competing drugs, demonstrating both efficacy and safety.

IN-115314 is a novel Janus kinase-1 (JAK-1) inhibitor for the treatment of atopic dermatitis. HK inno.N is currently developing treatments for atopic dermatitis targeting both humans (ointment formulation) and companion animals (oral formulation). This presentation at EADV 2025 covers the results from the Phase 1 clinical trial in which the ointment was administered to humans for the first time.

The Phase 1 trial was conducted in two parts. In the first part, the safety and tolerability of the IN-115314 ointment were assessed after dose-specific single and repeated applications in healthy adult males. The second part involved assessments of safety and tolerability of the IN-115314 ointment (1%, 3%) compared to the control drug (pimecrolimus ointment) used in adult patients with mild to moderate atopic dermatitis twice daily for 4 weeks, followed by an exploratory assessment of efficacy.

When evaluating the EASI in adult patients with mild to moderate atopic dermatitis, the EASI scores significantly decreased from baseline to the first week of application in all dose groups treated with the IN-115314 ointment, and at Week 4, the average reduction rate reached up to 77.8%, demonstrating a superior outcome compared to the control drug.

Additionally, statistically significant improvements from baseline were observed in the IN-115314 ointment groups for ▲ Investigator Global Assessment (IGA), ▲ Numerical Rating Score for Pruritus (NRS for Pruritus), and ▲ Dermatology Life Quality Index (DLQI).

In the safety and tolerability assessments, there were no adverse events observed in association with dose increase or repeated administration of the IN-115314 ointment. Notably, major side effects of JAK inhibitors, including decreased absolute neutrophil count and reactivation of herpes zoster, were not observed.

Moreover, in the comparison of the minimum blood concentration at steady state where a drug concentration in the body remains constant, the competing drugs in the same class reached up to 20% of the Inhibitory Concentration 50% (IC50), which is the reference concentration to inhibit the JAK receptor, whereas the IN-115314 ointment reached only 1.2%, indicating a significantly lower risk of side effects associated with systemic exposure.

“IN-115314 ointment is expected to be recognized as a novel drug overcoming the limitations in the safety and efficacy of other conventional topical therapies for atopic dermatitis, broadening treatment options available to patients. Currently, a Phase 2 clinical trial in 162 patients is ongoing at 12 sites in Korea to explore the optimal dosage, and we are preparing clinical trials in the U.S. to reach global top markets,” commented an HK inno.N's representative.

The EADV, which is Europe’s largest dermatology conference, marked its 34th anniversary this year. Over 17,000 experts, mainly dermatology professionals, gathered from around the globe, exhibiting its great scale and influence in this field. (The End)

Reference Information

Title of poster presentation: A Novel Topical JAK1 Inhibitor for Atopic Dermatitis : Safety and Early Efficacy of IN-115314

EADV: European Academy of Dermatology and Venereology

EASI: Eczema Area and Severity Index

IGA: Investigator Global Assessment

DLQI: Dermatology Life Quality Index

NRS for Pruritus: Numerical Rating Score for Pruritus

IC50: Inhibitory Concentration 50%; it refers to the concentration of a specific inhibitor necessary to inhibit a biological process or enzyme activity by 50%, serving as a reference concentration to determine the efficacy and safety when designing a clinical trial.