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SEQ_NO
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1
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Date of announcement
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2023/04/28
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Time of announcement
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21:44:27
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Subject
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Announce the Phase 1 clinical trial data of SNS812 a broad-spectrum antiviral siRNA for COVID-19
developed jointly by Microbio (Shanghai) Co.,Ltd. and Oneness.
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Date of events
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2023/04/28
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To which item it meets
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paragraph 53
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Statement
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1.Date of occurrence of the event:2023/04/28
2.Company name:Microbio (Shanghai) Co.,Ltd.
3.Relationship to the Company (please enter ”head office” or
”subsidiaries”):subsidiary
4.Reciprocal shareholding ratios:NA
5.Cause of occurrence:
(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 measurement (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 (AUCo-t), and to infinity (AUCo-∞)
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 and the associated measures the
Company may occur: NA
C. After obtaining official approval or the results (include interim
analysis) which are statistically significant, 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 Microbio (Shanghai) Co.,Ltd.
and Oneness.
(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.
6.Countermeasures:NA
7.Any other matters that need to be specified(the information
disclosure also meets the requirements of Article 7, subparagraph 9
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.
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