Announcement of the Phase 1 clinical trial data of SNS812, a broad-spectrum antiviral siRNA for COVID-19 developed jointly by Oneness and Microbio (Shanghai) Co.,Ltd.

Published Date:2023-04-28

Original Link:https://www.onenessbio.com/en/news_detail225_4.htm

Statement
No	1	Date of announcement	2023/04/28	Time of announcement	22:12:32
Subject	Announcement of the Phase 1 clinical trial data of SNS812, a broad-spectrum antiviral siRNA for COVID-19 developed jointly by Oneness and Microbio (Shanghai) Co.,Ltd.
To which item it meets	paragraph 10			Date of events	2023/04/28
Product:SNS812, a broad-spectrum siRNA for treatment of SARS-CoV-2 infection Mass production date:NA Effect on company finances and business: (1)New drug name or code:SNS812 (2)Purpose:A.Treatment of 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 (New Drug Application) (4)Current development stage: A.File application/approved/disapproved/Each of clinical trials (include interim analysis): (A)Clinical Trial Design a.Protocol Title：A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled SNS812 in Healthy Participants. b.Study Purpose：A phase I clinical trial conducted at a single center in the United States using a randomized, controlled, and placebo-controlled design to evaluate the safety, tolerability, and pharmacokinetics of SNS812 in healthy subjects. c.Phase of Study：Phase I clinical trial d.Investigational product：SNS812 e.Indication：Treatment of COVID-19 infection f.Endpoints： Primary endpoints：The safety and tolerability of SNS812. Secondary endpoints: Pharmacokinetics (PK) and immunogenicity. g.Number of subjects enrolled：44 healthy participants (B)Primary and secondary endpoints and the statistical results： a.Primary endpoint and the statistical results: (a)The trial results showed that SNS812 was well-tolerated and safe in healthy subjects, even at the highest dose tested up to 1.2 mg/kg. Among the 44 healthy subjects included in the trial, no drug-related serious adverse reactions (SAE) occurred. All adverse events (AEs) were not drug-related and had resolved before the end of the trial. (b)All clinical laboratory tests (hematology, serum chemistry, liver function, coagulation function and urine test), vital signs easurement (systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and body temperature), 12-lead electrocardiogram, pulmonary function tests and physical examination results for all subjects showed that SNS812 had no adverse effects. (c)The maximum tolerated dose (MTD) of SNS812 was >1.2 mg/kg. b.Secondary endpoint and the statistical results: (a)Pharmacokinetics (PK): After inhalation of a single dose of SNS812 at 0.3, 0.6, and 1.2 mg/kg in healthy subjects, all the maximum blood drug concentration (Cmax), and the total area under the concentration-time curve from time zero to the final blood collection point (AUC0-t), and to infinity (AUC0-∞) increased with the increasing dose.The half-life in vivo was about 5-7 hours. The results indicate that SNS812 has good pharmacokinetic properties and will be helpful for the design and planning of phase II clinical trials in the future. (b)Immunogenicity: No autoantibodies against SNS812 were produced after SNS812 administration. c.Exploratory endpoint and the statistical results:NA d.Safety evaluation results:SNS812 at a dose of 1.2 mg/kg has good safety and tolerability in healthy subjects. (C)The results of a single clinical trial (including the p value or whether there is statistical significance in primary, secondary endpoints) shall not be sufficient to reflect the success or failure of the new drug in the future development. The investors shall be careful in judgement and investment. B.Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur:NA C.After obtaining official approval or the results of statistically significant sense, the future strategy:to submit the application for a Phase 2 clinical trial to the US FDA. 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 clinical trial A.Scheduled completion date: Based on the Phase 1 clinical trial results, we are actively designing a Phase 2 clinical trial and plan to submit the application to the US FDA in Q2 of 2023. The exact completion date will be subject to the progress of regulatory review and actual enrollment status. B.Estimate responsibilities:SNS812, a broad-spectrum antiviral siRNA for COVID-19, is developed jointly by Oneness and Microbio (Shanghai) Co.,Ltd. (6)Market: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. 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. Compared to current oral antiviral drugs on the market, SNS812 has demonstrated a good safety profile and shows promise in resisting viral mutations, making it a potential new generation of anti-coronavirus therapeutics that can be used over the long-term. 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 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. (2)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.