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合一生技股份有限公司 / 2024 / SNS812 Phase 2 study demonstrated statistical significance in treating COVID-19 based on its safety, precision and broad-spectrum efficacy.

SNS812 Phase 2 study demonstrated statistical significance in treating COVID-19 based on its safety, precision and broad-spectrum efficacy.

2024-09-08

Published Date:2024-09-08

Original Link:https://www.onenessbio.com/en/news_detail317_1.htm

No 1 Date of announcement 2024/09/08 Time of announcement 17:16:12
Subject SNS812 Phase 2 study demonstrated statistical significance in treating COVID-19 based on its safety, precision and broad-spectrum efficacy.
To which item it meets paragraph 10 Date of events 2024/09/06
Statement
  1. Date of occurrence of the event: 2024/09/06
  2. New drug name or code: SNS812
  3. Indication:
    1. (1) To treat COVID-19 infection
    2. (2) Information Website: https://clinicaltrials.gov/study/NCT05941793
  4. Planned development stages: Emergency Use Authorization；Phase 2 / 3 clinical trial / New drug application
  5. Current development stage:
    1. (1) File application/approved/disapproved/Each of clinical trials (include interim analysis):
      1. (A) Clinical Trial Design
        1. a.Protocol Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of SNS812 in Participants with Mild to Moderate COVID-19.
        2. b.Study Purpose: To evaluate the safety, efficacy (including the alleviation and resolution of 14 target COVID symptoms) and pharmacokinetics of SNS812 in treating COVID-19 infected subjects.
        3. c.Phase of Study: Phase 2 clinical trial
        4. d.Investigational product: SNS812
        5. e.Indication: Treatment of COVID-19 infection
        6. f.Endpoints: Primary endpoints: The safety and tolerability of SNS812 compared with placebo. Secondary endpoints:The efficacy and pharmacokinetics of SNS812 compared with placebo.
        7. g.Number of subjects enrolled: 135 subjects with COVID-19 infection were randomized to receive placebo, SNS812 (100mg) and SNS812 (200mg). 45 subjects in each treatment group. This study was greenlighted to proceed by the regulatory authorities in Taiwan and the U.S. Under the competitive enrollment, all 135 subjects were recruited from Taiwan.
      2. (B) Primary and secondary endpoints and the statistical results:
        1. a.Primary endpoint and the statistical results:
          1. (a) The study results showed that among 135 COVID-19 infected subjects receiving either a placebo, SNS812 (100mg), or SNS812 (200mg), there were no drug-related TEAEs (treatment-emergent adverse events) or SAEs (serious adverse events) reported.
          2. (b) The incidence of TEAEs (treatment-emergent adverse events) in the placebo group, SNS812 (100mg) group, and SNS812 (200mg) group showed no statistically significant differences during the study period, indicating that SNS812 has been well tolerated.
        2. b.Secondary endpoint and the statistical results:
          1. (a) Time to Sustained Resolution of All Targeted Symptoms: The time to sustained resolution of all targeted symptoms (including fever, sore throat, chills, headache, shortness of breath, nausea, vomiting, loss of smell, and loss of taste) over 28 days was significantly earlier in the SNS812 groups compared to the placebo group (P = 0.007).
          2. (b) Time to Sustained Alleviation of All Targeted Symptoms: The SNS812 (200mg) group achieved sustained alleviation of all targeted symptoms (including fever, sore throat, chills, headache, shortness of breath, nausea, vomiting, loss of smell, and loss of taste) over 28 days earlier than the placebo group (P = 0.019).
          3. (c) Time to Sustained Resolution or Alleviation of Five Non-Targeted Symptoms (including cough, muscle or body aches, fatigue, nasal congestion or runny nose, and diarrhea): The SNS812 groups achieved sustained alleviation of cough earlier than the placebo group (P = 0.043). Due to fewer cases or non-targeted nature by SNS812 for the other four symptoms, there is no statistical significant difference between SNS812 groups and placebo. However, the SNS812 (200mg) group showed better outcomes in the sustained resolution or alleviation of muscle or body aches, fatigue, and nasal congestion or runny nose compared to the placebo group, while the effect on diarrhea was similar to that of the placebo group.
          4. (d) The time to sustained alleviation and resolution of target symptoms (including fever, sore throat, chills, headache, shortness of breath, nausea, vomiting, loss of smell, loss of taste, and others) over 60 days: Compared to the placebo group, the SNS812 group achieved sustained symptom alleviation earlier on day 7 (P = 0.028) and symptom resolution earlier on day 9 (P = 0.025). All three groups reached 100% sustained alleviation and resolution of symptoms by day 60.
          5. (e) Medical Needs, Higher Levels of Care, or Death Related to COVID-19 through 60 Days: Neither the SNS812 groups nor the placebo group experienced any medical needs, higher levels of care, or deaths related to COVID-19.
          6. (f) All-Cause Mortality through 60 Days: The all-cause mortality rate was 0% in both the SNS812 group and the placebo group.
          7. (g) Impact on Neutrophils and Lymphocytes: The SNS812 groups and the placebo group both showed no effect on neutrophils or lymphocytes.
        3. c.Exploratory endpoint and the statistical results:
          1. (a) Time to Covid-19 antigen test results change from positive to negative: SNS812 groups achieved negative of Covid-19 antigen test earlier than the placebo group (P=0.018). The median time to achieve negative of Covid-19 antigen test in SNS812 (200mg) group is just 2.9 days.
          2. (b) Analysis of COVID-19 Virus Variants: This study enrolled 135 subjects, each of whom had their virus strain cultured and isolated. Analysis showed that the infected COVID-19 strains included various genotypes such as JN.1, KP1-4, LB.1, BA.2, and XBB. Among these, the JN.1 variant, which is currently prevalent globally this year, accounted for about half of the study subjects.
        4. d.Safety evaluation results: No SNS812-related adverse effects was found.
      3. (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.
    2. (2) Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, therisks & the associated measures the Company may occur: NA
    3. (3) After obtaining official approval or the results of statistically significant sense, the future strategy: Seeking cooperation with international pharmaceutical companies or governments to submit an EUA (Emergency Use Authorization) application or subsequent clinical trial applications.
    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: Based on the results of the Phase 2 clinical trial, we will actively seek cooperation with international pharmaceutical companies or governments to submit an EUA application or subsequent clinical trial applications. The final completion time will depend on the negotiation process and the review status of the relevant regulatory authorities.
    2. (2) Estimate responsibilities: SNS812, a broad-spectrum si-RNA drug for treating COVID-19 infection, is co-developed by Oneness Biotech Co., Ltd. and Microbio (Shanghai) Co., Ltd.
  7. Market situation:
    1. (1) The leading medical journal, The New England Journal of Medicine (NEJM), published a clinical trial involving 1,440 subjects in April 2024. The results showed that Paxlovid, the treatment with a 70% global market share, did not have a significant efficacy on alleviating COVID-19 symptoms. Another leading journal, The Lancet Infectious Diseases, February 2024 reported that the immune escape of the COVID-19 virus has been increasing. The neutralization by the serum from patients infected with the prevalent virus strain (XBB1.5) in Q2-Q3 2023 against the new virus strain (JN.1) emerging just six months later has decreased by 5.6-fold, indicating that vaccines are lagged behind the viral evolution. A new safe and effective drug with efficacy accommodating all viral mutations is needed.
    2. (2) Despite that the COVID-19 pandemic becomes endemic, Paxlovid with limited efficacy and significant side effects, still generated sales exceeding $2 billion in the first half of 2024, demonstrating the substantial demand for COVID-19 therapeutics. Additionally, given COVID-19 is a disease with a several times higher mortality and transmissibility than that of the flu, it is anticipated that COVID-19 medications will be a long-term demand. Compared to existing oral antiviral drugs, SNS812, which is administered via aerosol inhalation, offers safety, efficacy, and precision, and has the potential to become a unique next-generation broad-spectrum antiviral drug for coronavirus on a global level.
  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.): None.
  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.: