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

Published Date:2023-05-31

Original Link:https://www.onenessbio.com/en/news_detail222_3.htm

Statement
No	1	Date of announcement	2023/05/31	Time of announcement	23:56:02
Subject	Oneness submitted an IND to US FDA for a phase II 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	2023/05/31
Product:SNS812, a broad-spectrum siRNA against SARS-CoV-2 virus Mass production date:NA Effect on company finances and business: (1)New drug name or code:SNS812 (2)Purpose: A.Treatment for COVID-19 infection B.Information Website:https://clinicaltrials.gov/ct2/show/NCT05677893 (3)Planned development stages：Phase II clinical trial/ Phase III clinical trial/NDA (4)Current development stage: The phase I study of SNS812 has been completed in the US, obtaining comprehensive pharmacokinetic parameters and preliminary validation of its safety in humans. An IND application for the phase II study in treating COVID-19 infection has been submitted to explore the efficacy, safety, tolerability, and pharmacokinetic characteristics of SNS812 in patients with COVID-19. A.File application/approved/disapproved/Each of clinical trials (include interim analysis):Submit an IND application to the US FDA for Phase II 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: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:phase II / III clinical trial A.Scheduled completion date:The actual schedule will depend on the progress of the US FDA review. B.Estimate responsibilities:SNS812, a broad-spectrum antiviral siRNA for COVID-19, is developed jointly by Oneness Biotech Co., Ltd. and Microbio (Shanghai) Co., Ltd.. (6)Market: Based on the data published on May 17, 2023, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected more than 766 million people worldwide and caused more than 6.93 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 emergence of the Omicron variant has highlighted not only the rapid mutation rate of the SARS-CoV-2 virus, but also its astonishing global transmission speed. SNS812 has the potential to be an anti-coronavirus drug unaffected by viral mutations, allowing for long-term usage. While the annual number of flu patients worldwide ranges from 10 to 20 million, with up to 40 million during pandemics, Roche’s Tamiflu has generated over $1 billion in annual revenue. However, given the significantly higher infectivity of the SARS-CoV-2 virus, with over 150 million people infected annually and the number of infections continuing to rise, the market for COVID-19 treatments is predicted to surpass that of traditional flu drugs, reaching $16.2 billion by 2031, according to the well-known analytical firm Transparency Market Research. 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)SNS812 is a broad-spectrum siRNA therapeutic targeting SARS-CoV-2 variants, effectively covering 99.8% of the current SARS-CoV-2 variants. It has demonstrated picomolar inhibition against dominant variants, 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 continues to evolve. In addition to verifying its efficacy in treating COVID-19 infection, SNS812 is positioned as a treatment solution to the periodic outbreak of life-threatening COVID-19. (3)According to Article 2 under 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 or new drug application 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.