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合一生技股份有限公司 / 2022 / Oneness submitted an IND to US FDA for a phase I clinical trial on the broad-spectrum anti-SARS-CoV-2 siRNA (SNS812) co-developed with Microbio (Shanghai)

Oneness submitted an IND to US FDA for a phase I clinical trial on the broad-spectrum anti-SARS-CoV-2 siRNA (SNS812) co-developed with Microbio (Shanghai)

2022-08-23

Published Date:2022-08-23

Original Link:https://www.onenessbio.com/en/news_detail175_2.htm

No 1 Date of announcement 2022/08/23 Time of announcement  22:58:56
Subject Oneness submitted an IND to US FDA for a phase I clinical trial on the broad-spectrum anti-SARS-CoV-2 siRNA (SNS812) co-developed with Microbio (Shanghai)
To which item it meets paragraph 10 Date of events 2022/08/23
Statement
  1. Product:SNS812, a broad-spectrum siRNA against SARS-COV-2 virus
  2. Mass production date:NA
  3. Effect on company finances and business:
    (1)New drug name or code:SNS812
    (2)Purpose:Treatment for COVID-19 infection
    (3)Planned development stages：Phase I, Phase II, Phase III, NDA
    (4)Current development stage:
    A.File application/approved/disapproved/Each of clinical trials (include interim analysis):Submit an IND application to the US FDA for Phase I clinical trial.
    B.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
    C.After obtaining official approval or the results (include interim analysis) of statistically significant sense, the future strategy: Not applicable
    D.Accumulated investment expenditure incurred: Considering the future marketing strategy and to protect the rights and interests of the company and investors, it will not be disclosed publicly.
    (5)Upcoming development plan:Phase I, Phase II, Phase III
    A.Scheduled completion date: The actual schedule will depend on the progress of the US FDA review.
    B.Estimate responsibilities:SNS812 is a broad-spectrum siRNA new drug co-developed by Oneness Biotech Co., Ltd. and Microbio (Shanghai) Co., Ltd.
    (6)Market:Based on the data published on August 22, 2022, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected more than 596 million people worldwide and caused more than 6.68 million deaths. With the occurrence of vaccine breakthrough and repeated COVID-19 infections caused by new variants, it is anticipated that the future new variants will lead to periodic global epidemics. The coexistence of the SARS-CoV-2 and human beings seems inevitable and the broad-spectrum therapeutics against SARS-CoV-2 will be able to address the large medical needs.
  4. Any other matters that need to be specified:
    (1)SNS812 is a broad-spectrum siRNA therapeutic against SARS-CoV-2 variants covering 99.8% of current SARS-CoV-2 variants and shown a picomolar inhibition of dominant ones, including Alpha, Delta, Gamma, Epsilon and Omicron. Moreover, the K18-hACE2-transgenic mice studies demonstrated that SNS812 could completely inhibit the production of infectious virions in lungs by prophylactic treatment and decrease 96.2% of virions by post-treatment. It is also noted that virus-associated extensive pulmonary alveolar damage, vascular thrombi, and immune cell infiltrations have been significantly reduced by SNS812 treatment.
    (2)The COVID-19 pandemic has continued to evolve. SNS812 is positioned as a treatment solution to the periodic outbreak of life-threatening COVID-19 in addition to verifying SNS812 in treatment and prevention of SARS-CoV-2 infection.
    (3)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.
    (4)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.