Shaperon, a domestic bio corporation, has confirmed the safety and efficacy of its atopic dermatitis treatment candidate "Nugel" in a global phase 2 clinical trial. There are assessments that the green light has been turned on for follow-up clinical trials and global technology transfer.
According to Shaperon on the 14th, an independent "Safety Monitoring Committee (SMC)" operating under U.S. Food and Drug Administration (FDA) regulatory guidelines reviewed the results of part 1 of the phase 2 clinical trial of Nugel and recommended that the company continue with the subsequent phase 2b part 2 trials.
The company disclosed the results of part 1 of the phase 2 clinical trial of Nugel during the BFC Global Healthcare Investment Conference held in San Francisco, U.S., on the 12th (local time), and noted that there were many questions and answers related to commercialization during the event. From the 13th to the 16th (local time), the company will participate in the "2025 JPMorgan Healthcare Conference (JPMHC)" in San Francisco to engage in in-depth technology transfer discussions with multinational pharmaceutical companies.
Nugel is a treatment candidate for mild to severe atopic dermatitis, being developed based on a novel anti-inflammatory complex inhibition principle.
According to the company, part 1 of the phase 2 clinical trial for Nugel was conducted on 33 multi-ethnic patients with mild or moderate atopic dermatitis in the United States, starting in December 2023. The dosage of Nugel was increased up to eight times compared to the previously conducted phase 2a study in South Korea, and the trial duration was also doubled to 8 weeks. This was done to verify a more precise range of the drug's safety and effective dosage.
Through this, the safety and efficacy of Nugel were confirmed. In the safety trial evaluating four different Nugel dosages and a placebo, the incidence of drug-related adverse reactions was found to be either 0 or 1 in each test group. In the placebo group, 2 cases were reported, indicating that there was no significant difference in drug-related side effects compared to the placebo group. No serious adverse drug reactions were observed. It was found safe even when administered at doses eight times higher than the trial dosage in South Korea for 8 weeks.
In the evaluation of therapeutic efficacy, Nugel demonstrated superior efficacy compared to currently marketed competitive drugs. In the evaluation of the drug effects of atopic treatments based on the Eczema Area and Severity Index (EASI) score, Nugel showed an excellent effect with a difference of 15-40% compared to approved competitive drugs and placebos in the market for patients with mild to moderate atopic dermatitis. Regarding the key indicator for FDA approval, the Investigator's Global Assessment (IGA) success measure (IGA-TS), the group receiving specific dosages of Nugel demonstrated over 39% clinical remission compared to the placebo, showing comparable or superior efficacy to existing treatments.
A company official noted, "The IGA success measure was comparable to competitive drugs, but the competitive drugs had to have a warning on their packaging regarding 'potential cancer occurrence' as a condition for approval," adding, "If Nugel is successfully developed in the future, I believe it can gain a competitive advantage by emphasizing its superior efficacy and safety."
Based on the recent recommendation from the SMC, Shaperon plans to conduct follow-up phase 2 trials involving 177 patients of various ethnicities at a total of 12 hospitals, adding 4 hospitals each in the U.S. and South Korea to the existing 4 hospitals. The phase 2 trial is expected to start in February and conclude by the first half of 2026. A company official emphasized, "Having secured positive results in this phase 1 trial has significantly increased the likelihood of Nugel's commercialization, hence we are actively advancing our business to expedite the technology transfer to global pharmaceutical companies."
Market research firm Facts & Factors forecasts that the global atopic dermatitis treatment market will grow at an average annual rate of 8.2% and reach approximately 37.9 trillion won by 2032. Major competing drugs currently on the market, including JAK inhibitors and PDE4 inhibitors, are expected to generate revenues of about 2.3 trillion won and about 1.5 trillion won, respectively, this year.