Article | "StartPointAdvisors" Weibo
On November 29, 2023, Beijing Pucci Pharma Technology Co., Ltd (Pucci Pharma, Stock Code: 873969), a partner of StartPoint, announced that the Phase IIb clinical study of the company's proprietary Class 1.1 drug Pumecitinib Gel (PG-011) for the treatment of adults with mild to moderate atopic dermatitis (AD) has been successfully completed and the primary secondary clinical endpoints have been analyzed. The Phase IIb clinical study of Pumecitinib gel (PG-011) for the treatment of atopic dermatitis (AD) in adults with mild to moderate atopic dermatitis has successfully completed the blinding and data analysis of the trial, and the primary and secondary clinical endpoints have been met.

Pemetrexedinib is a novel topical JAK inhibitor independently developed by Pucci Pharma with full intellectual property rights. This announcement is a multicenter, randomized, double-blind, excipient-parallel controlled Phase IIb clinical study (Clinical Registry No. CTR20230499) to evaluate the efficacy and safety of pemetrexedinib for 8 weeks in the treatment of mild to moderate atopic dermatitis in adolescents and adults 12 years of age and older as well as the long-term safety of pemetrexedinib for 52 weeks.

A total of 138 adult patients with mild and moderate atopic dermatitis were enrolled in this study, and subjects were divided into three groups in a 1:1:1 ratio to receive pemetrexedinib 3% gel twice daily (46 patients), pemetrexedinib 3% gel once daily (46 patients), and a placebo group (46 patients). The primary efficacy endpoint was the percentage change from baseline in the Eczema Area and Severity Index (EASI) score at week 8, and secondary endpoints included the proportion of subjects with an EASI-75 (≥75% reduction from baseline in the EASI score), the proportion of subjects with an EASI-90 (≥90% reduction from baseline in the EASI score), and the rate of IGA response (IGA scores of 0 or 1 with a reduction from baseline of ≥2 points), and the proportion of subjects with an IGA score of 0 or 1.

The results showed that for the primary endpoint, the percentage change from baseline in EASI scores at week 8 was higher in the pemetinib gel twice-daily and once-daily dosing groups (83.6%, 44.0%) than in the placebo group (22.0%), and that both treatment groups of pemetinib gel showed statistically significant superiority over the placebo group after 8 weeks of treatment (p<0.001).

For secondary endpoints, the percentage of subjects achieving EASI-75 at week 8 was 69.6%, 19.6%, and 2.2%, respectively, the percentage of subjects with an IGA response rate was 45.7%, 6.5%, and 2.2%, respectively, and the percentage of subjects with an IGA score of 0 or 1 after 8 weeks of treatment was 67.4%, 19.6%, and 2.2%, respectively. The study demonstrated that pemetrexedinib gel showed a favorable safety and tolerability profile in adults with mild to moderate atopic dermatitis.

Pukki said that the company will soon communicate with the National Center for Drug Evaluation (CDE) about the results of the above IIb study and the plan for the Phase III clinical study.