SNS812, a broad-spectrum siRNA for COVID-19 infection, co-developed by Oneness & Microbio (Shanghai) has been agreed by US FDA to proceed with Phase 2 clinical trial.

Published Date:2023-08-02

Original Link:https://www.onenessbio.com/en/news_detail236_2.htm

Statement
No	1	Date of announcement	2023/08/02	Time of announcement	21:48:19
Subject	SNS812, a broad-spectrum siRNA for COVID-19 infection, co-developed by Oneness & Microbio (Shanghai) has been agreed by US FDA to proceed with Phase 2 clinical trial.
To which item it meets	paragraph 10			Date of events	2023/08/02
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://classic.clinicaltrials.gov/ct2/show/NCT05941793?cond=SNS812&draw=2&rank=1 (3)Planned development stages：Phase II clinical trial/ Phase III clinical trial/NDA (4)Current development stage: A.File application/approved/disapproved/Each of clinical trials (include interim analysis):SNS812, a broad-spectrum siRNA for treatment of SARS-COV-2 infection, has been agreed by the US FDA to proceed with the phase 2 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 timeline will depend on the progress of the trial and the review of the regulatory agency. 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 July 26, 2023, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected more than 768 million people worldwide and caused more than 6.95 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. Pfizer announced in 2023 that its COVID-19 treatment drug (Paxlovid) has witnessed a significant surge in Q1 sales, soaring from US$1.4 billion in 2022 to US$4.1 billion this year. This far exceeds Wall Street’s expectation of US$2.7 billion, highlighting the immense market demand for COVID-19 treatment drugs. 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)According to the Good Review Practice specified in the FDA’s Policy and Procedures, the review period for the phase 2 clinical trial protocol is 60 calendar days after submission, which is due by July 30. After confirming with the FDA via email, they informed us today that the review of this trial cannot be completed at the moment due to an increased review load for other cases. However, the FDA has agreed to allow Oneness to proceed with this phase 2 trial. (2)On June 28, 2023, SNS812 has been greenlighted by the Taiwan TFDA to proceed with the phase II clinical trial. This phase II clinical trial will enroll participants simultaneously in both the US and Taiwan to expedite the trial’s progress. In Taiwan, participant enrollment will begin in September at the main hospital and Yunlin branch of National Taiwan University Hospital. (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.