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合一生技股份有限公司 / 2024 / Submission of a phase II clinical trial protocol to Taiwan FDA for subcutaneous injection formulation of FB825 in patients with moderate-to-severe atopic dermatitis

Submission of a phase II clinical trial protocol to Taiwan FDA for subcutaneous injection formulation of FB825 in patients with moderate-to-severe atopic dermatitis

2024-03-29

Published Date:2024-03-29

Original Link:https://www.onenessbio.com/en/news_detail279_4.htm

No 1 Date of announcement 2024/03/29 Time of announcement 18:08:07
Subject Submission of a phase II clinical trial protocol to Taiwan FDA for subcutaneous injection formulation of FB825 in patients with moderate-to-severe atopic dermatitis
To which item it meets paragraph 10 Date of events 2024/03/29
Statement
  1. Date of occurrence of the event:2024/03/29
  2. New drug name or code:FB825
  3. Indication:
    1. (1)Treatment for moderate-to-severe atopic dermatitis, allergic asthma and other IgE-mediated allergic diseases
    2. (2)Information Website: has not submitted to Taiwan Clinical Trial Information System
  4. Planned development stages:Phase II clinical trial
  5. 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 II 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 Taiwan 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.

    1. (1)File application/approved/disapproved/Each of clinical trials (include interim analysis): Submit an IND to Taiwan FDA for a phase II clinical trial of the subcutaneous injection formulation of FB825 in patients with moderate-to-severe atopic dermatitis.
    2. (2)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.
    3. (3)After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Not applicable.
    4. (4)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.
  6. Upcoming development plan:
    1. (1)Scheduled completion date: Not applicable.
    2. (2)Estimate responsibilities: Not applicable.
  7. Market situation: 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.
  8. 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. (1)On January 30, 2024, an IND application for the phase II clinical trial was submitted to the US FDA. The trial is jointly conducted with our partner and will be concurrently implemented in multiple medical centers in the United States and Taiwan.
    2. (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.
  9. New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks.The investors are advised to exercise caution and conduct thorough evaluation.