("Enitiate Bio") has achieved its primary endpoint in the Phase II clinical trial of QY201 Tablets, a Class 1 innovative drug independently developed by Enitiate Bio, for the treatment of moderate-to-severe atopic dermatitis, with statistically significant and clinically meaningful results, as well as favorable safety and tolerability. Based on the results of the Phase II clinical trial, the company is making preparations for subsequent later stage clinical development.
This phase II clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 12-week continuous dosing design, aiming at evaluating the efficacy, safety, and group pharmacokinetic characteristics of QY201 tablets in adult patients with moderate-to-severe atopic dermatitis, as well as providing a basis for the selection of dosage for the phase III clinical trial. Led by Prof. Wu Liming of the Department of Dermatology of the First People's Hospital of Hangzhou, the study was successfully conducted in 28 hospitals nationwide, enrolling 200 subjects with moderate-to-severe atopic dermatitis, and the database locking, unblinding, and statistical analysis have been successfully completed recently. The results of the study showed that the primary efficacy endpoint, the proportion of subjects reaching EASI 75 at week 12, was statistically significantly different between the QY201 tablets low, medium and high dose groups compared with the placebo group (P < 0.0001). The key secondary efficacy endpoint, the proportion of subjects achieving an IGA score of 0 or 1 and a decrease of ≥2 points from baseline at week 12, was consistent with these results. For the other secondary efficacy endpoints, the proportion of subjects achieving EASI 50, EASI 90, and EASI 100 at week 12, and the rate of change from baseline in EASI at each visit, the QY201 tablets were superior to the placebo group in all dose groups, with statistically significant differences. For itch indicators, the rate of change from baseline in PP-NRS weekly averages at week 1, the proportion of subjects with a decrease of ≥3 points from baseline at week 1, and the proportion of subjects with a decrease of ≥4 points from baseline at week 2 (week 1 in the high-dose group) were better in each dose group of QY201 Tablets than in the placebo group, with statistically significant differences, and the improvement persisted until week 12. In terms of safety, QY201 tablets were administered continuously for 12 weeks, and the overall safety and tolerability were favorable, with TEAE mostly in CTCAE grade 1-2. In conclusion, QY201 tablets can rapidly stop itching, clear skin lesions, and improve the quality of life of patients with moderate-to-severe atopic dermatitis. The excellent data from the phase II clinical trial of QY201 tablets for the treatment of moderate-to-severe atopic dermatitis lay a solid foundation for the next step of conducting phase III clinical trials.
QY201 tablets are a new generation of highly active JAK1/TYK2 dual-target inhibitors independently developed by Enitiate Biologicals, and are highly selective for JAK2.QY201 has global intellectual property rights, and its patent application has been authorized by many major countries and regions. By blocking the JAK-STAT pathway through inhibition of JAK activity, QY201 reduces the expression of pro-inflammatory cytokines, thereby exerting therapeutic effects on autoimmune diseases such as atopic dermatitis and psoriasis.QY201 inhibits both JAK1 and TYK2 with high selectivity and activity, signaling that the risk of toxicity due to QY201 inhibition of other kinase targets is low.
About EnitiateBio
Founded in 2020, EnitiateBio (Hangzhou) Co., Ltd. is an innovative pharmaceutical company focusing on the development of innovative drugs for autoimmune diseases, which is dedicated to solving patients' unmet needs and improving the quality of human life.
The company is headquartered in Hangzhou, Zhejiang Province, with a medical and R&D centre in Shanghai. The company's self-developed QY201 had won the second prize of the 2020 Hangzhou Overseas High-level Talents Innovation and Entrepreneurship Competition National Finals (first prize of the Life and Health Group), and was supported by the key policies of Hangzhou Linping District. In 2021, the company entered into a strategic cooperation with Beda Pharmaceuticals to jointly promote the clinical translational development of the company's drugs.
Adhering to the value concept of "embracing competition, relentless pursuit, and frank dedication", the company has attracted many talents to join it, and has set up a transformation team with successful experience in new drug research and development, medical transformation, clinical management, and business operation. QY201, QY101 and QY211, which are the first class of innovative drugs with global patents developed by the company, are in the clinical trial stage, and have been approved for more than 30 clinical approvals and more than 10 indications.
The company has been elected as the first vice president of China Dermatology New Drug Alliance (PhDA) to jointly promote the linkage of "government, industry, academia, research and medicine" in dermatology, always focusing on patients' unsatisfied clinical needs, independently researching and developing differentiated molecules, and prospectively laying out the layout of autoimmune diseases, and striving to become a leader in the development of innovative autoimmune disease drugs.
