| Subject |
Submission of a phase II clinical trial protocol for subcutaneous injection formulation of FB825 in patients with moderate-to-severe atopic dermatitis |
- Product: Subcutaneous injection formulation of FB825, Anti-CεmX monoclonal antibody
- Mass production date: NA
- Effect on company finances and business:
(1) New drug name or code: FB825
(2) Purpose:
- Treatment for moderate-to-severe atopic dermatitis, allergic asthma and other IgE-mediated allergic diseases
- Information Website: https://clinicaltrials.gov/
(3) Planned development stages: Phase II clinical trial
(4) Current development stage: FB825 has successfully developed a subcutaneous injection formulation and completed the enrollment of a bridging trial involving both intravenous and subcutaneous formulations among healthy subjects in the United States. Initial findings have affirmed the safety of the subcutaneous injection formulation. A phase 2 clinical trial application for the subcutaneous injection formulation of FB825 in patients with moderate-to-severe atopic dermatitis has been submitted via IND to the US FDA. The primary objectives of this study are to investigate the efficacy, safety, and pharmacokinetics associated with FB825's subcutaneous injection formulation in moderate-to-severe atopic dermatitis patients.
- File application/approved/disapproved/Each of clinical trials (include interim analysis): Submit an IND to US FDA for a phase II clinical trial of the subcutaneous injection formulation of FB825 in patients with moderate-to-severe atopic dermatitis.
- Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks and the associated measures the Company may occur: Not applicable.
- After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Not applicable
- Accumulated investment expenditure incurred: No disclosure of investment expenditure at the moment in consideration of future marketing strategies and to protect the interests of the company and investors.
(5) Upcoming development plan: Not applicable.
- Scheduled completion date: Not applicable.
- Estimate responsibilities: Not applicable.
(6) Market: Atopic dermatitis is a chronic and heterogeneous skin condition characterized by intense itching and eczematous lesions. It is the most common inflammatory skin disease in developed countries. According to the Global Report on Atopic Dermatitis 2022 by the International Eczema Council, up to 20% of children and 10% of adults in developed nations suffer from this condition. The market for atopic dermatitis is gradually gaining attention, becoming one of the target indications for pharmaceutical companies. According to a report from Mordor Intelligence, the atopic dermatitis treatment market is estimated to be $10.06 billion in 2024, with a projected compound annual growth rate (CAGR) of 7.18%, reaching $14.23 billion by 2029.
- Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 8 of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of the securities on public companies.):
(1) The trial is jointly conducted with our partner and will be concurrently implemented in multiple medical centers in the United States and Taiwan.
(2) According to Guidelines by Taipei Exchange on the Material Information Announced by Listed and OTC Companies, new drug development companies shall make public announcement when filing application for clinical trials to domestic or overseas regulatory authorities, receiving approval or disapproval, obtaining the statistical date of endpoints in each clinical trial (including interim analysis), or receiving approval or disapproval on drug license application.
(3) 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.
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