|No||1||Date of announcement||2021/12/12||Time of announcement||16:56:09|
|Subject||The partial efficacy data for the Phase 2a study of FB825 in the treatment of atopic dermatitis in the U.S. have been analyzed|
|To which item it meets||paragraph 10||Date of events||2021/12/11|
1.Product:FB825 anti-CεmX humanized monoclonal antibody
2.Mass production date:NA
3.Effect on company finances and business:
(1)New drug name or code:FB825 anti-CεmX humanized monoclonal antibody
(2)Purpose:A.Treatment of moderate-to-severe atopic dermatitis, allergic asthma, and other IgE related diseases
(3)Planned development stages：Phase II, Phase III, NDA
(4)Current development stage:
A.File application/approved/disapproved/Each of clinical trials (include interim analysis):
(a)The contracted CRO has proceeded according to the statistical analysis plan (SAP) with the efficacy analysis on EASI for the Phase 2a study of FB825 in the treatment of atopic dermatitis in the U.S.. The efficacy exploration analysis will be provided to the licensed partner to proceed with data interpretation and evaluation. This study has enrolled 99 subjects with moderate-to-severe atopic dermatitis. The patients were dosed with FB825 every 4 weeks, in total of 4 doses for the 16-week treatment period. This Phase 2a study is ongoing and all the efficacy endpoints, biochemical parameters, biopsies, pharmacokinetic and safety data are anticipated to be unblinded and analyzed upon completion with database lock in the 1st half of 2022. The final data and results will be announced upon the completion of all analyses.
(b)The analysis will not be disclosed according to the license agreement
(c)LEO Pharma has acquired the worldwide exclusive license to develop andcommercialize FB825.
B.Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur:Not applicable
C.After obtaining official approval or the results of statistically significant sense, the future strategy: Not applicable
D.Accumulated investment expenditure incurred:No disclosure of the investment expenditure at the moment in consideration of the future marketing strategies to protect the company and investors interests.
(5)Upcoming development plan:
A.Scheduled completion date:Not applicable
4.Any other matters that need to be specified:
It takes considerable time and expenses to develop a new drug of which success can't be guaranteed. Investors shall bear such investment risk that warrants careful assessment before making investment decisions