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Statement
| 1.Date of occurrence of the event: 2022/08/02
2.New drug name or code: FP-025, an Matrix metalloproteinase-12 (MMP-12)
inhibitor
3.Indication: For the treatment in patients with severe to critical COVID-19
with associated Acute Respiratory Distress Syndrome (ARDS)
4.Planned development stages: To conduct another phase 2 clinical trial in
other indication, followed by a phase 3 clinical trial and submit New Drug
Application
5.Current development stage:
(1) Application submission/approval/disapproval/each of clinical trials
(include interim analysis):
(A) Clinical Study Design：
a. Protocol Title：A Phase 2/3, Randomized, Double Blind, Placebo
Controlled, Multicenter Study to Evaluate the Efficacy and
Safety of FP-025 in Patients With Severe to Critical COVID 19
With Associated Acute Respiratory Distress Syndrome (ARDS)
b. Study Purpose：To evaluate the efficacy and safety of FP-025
in adult patients with severe to critical COVID 19 with
associated ARDS.
c. Phase of Clinical Study：The phase 2 portion of the phase 2/3
clinical trial
d. Investigational product：FP-025, an MMP-12 inhibitor
e. Indication：Severe to Critical COVID-19 with Associated Acute
Respiratory Distress Syndrome (ARDS)
f. Endpoints：
Primary endpoints：
The proportion of patients alive and not requiring non-invasive
or invasive ventilation at Day 28.
Secondary endpoints：
(a) The proportion of patients on invasive mechanical
ventilation at Day 28.
(b) The proportion of patients alive at Day 28.
(c) The proportion of patients alive and not requiring
non-invasive or invasive ventilation at Day 60.
(d) The proportion of patients on invasive mechanical
ventilation at Day 60.
(e) The proportion of patients alive at Day 60.
g. Number of subjects randomized：
90 subjects were randomized for the phase 2 clinical study, in
a 1:1:1 ratio into 1 of 3 treatment groups: FP-025 100 mg BID
(n=29), FP-025 300 mg BID (n=30), or placebo BID (n=31);
treatment for 28 days in combination with standard of care
treatment for COVID 19 (e.g. Remdesivir and several types of
steroids)
The phase 2 portion of the study is to evaluate the efficacy
and safety, not intended for registration. Sample size was
chosen empirically which is not powered to test statistical
significance at a p-value <=0.05.
(B) Primary and secondary endpoints and the statistical results：
a. Primary endpoint and the statistical results：
Based on the clinical trial data, the proportion of patients
alive and not requiring non-invasive or invasive ventilation
at Day 28：FP-025 high dose group (50%), FP-025 low dose
group (37.9%), and placebo group (54.8%). Both the results of
high dose group and low dose group demonstrated no
statistically significant benefit versus placebo
(P-value >0.05).
b. Secondary endpoint and the statistical results：
(a) The proportion of patients on invasive mechanical
ventilation at Day 28：FP-025 high dose group (33.3%),
FP-025 low dose group (48.3%), and placebo group (35.5%).
Both the results of high dose group and low dose group
demonstrated no statistically significant benefit versus
placebo (P-value >0.05).
(b) The proportion of patients alive at Day 28：FP-025 high
dose group (70%), FP-025 low dose group (65.5%), and
placebo group (71%). Both the results of high dose group
and low dose group demonstrated no statistically
significant benefit versus placebo (P-value >0.05).
(c) The proportion of patients alive and not requiring
non-invasive or invasive ventilation at Day 60： FP-025
high dose group (46.7%), FP-025 low dose group (37.9%),
and placebo group (48.4%). Both the results of high dose
group and low dose group demonstrated no statistically
significant benefit versus placebo (P-value >0.05).
(d) The proportion of patients on invasive mechanical
ventilation at Day 60： FP-025 high dose group (33.3%),
FP-025 low dose group (44.8%), and placebo group (35.5%).
Both the results of high dose group and low dose group
demonstrated no statistically significant benefit versus
placebo (P-value >0.05).
(e) The proportion of patients alive at Day 60： FP-025 high
dose group (70%), FP-025 low dose group (65.5%), and
placebo group (67.7%). Both the results of high dose
group and low dose group demonstrated no statistically
significant benefit versus placebo (P-value >0.05).
(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) Once disapproved by competent authority or each of clinical trials
(include interim analysis) results not reached statistically
significant sense, the risks & the associated measures the Company
may occur:
(A) Review of current topline data showed high degree of variability
in patient comorbidity (with only 1 of 90 patients were
considered not to have any comorbidities), and institution
standard of care evolution/changes, this meant that patients
treated in the early weeks of the trial received quite different
care and concomitant medications than those treated later;
likely trending vaccination rate among patients; high early
mortality; lower than expected patient registration all
contributing to influencing/underestimating statistical
analytic power, especially in the intend to treat (ITT) analysis.
Therefore, we don't over-interpret the statistical inferences.
(B) Additional biomarker data are anticipated in the next few weeks.
It may help to elucidate target engagement of FP-025 and MMP-12
better. Such data will also be helpful in designing other phase
2 trials mentioned above.
(3) After obtaining official approval or reaching the results of
statistically significant sense, the future strategy: N/A
(4) Accumulated investment expenditure incurred: Undisclosed
6.Upcoming development plan:
(1) Estimated date of completion: to conduct another phase 2 trial in
patients with other potential indications. The plan will be
announced as confirmed.
(2) Estimated responsibilities: R&D expenses for conducting other
clinical trial
7.Market situation:
Since the outbreak of novel coronavirus pneumonia (COVID-19) in
December 2019, approximately 570 million confirmed cases of
COVID-19 have been reported to WHO globally, including 6.4 million
deaths. According to research, hospitalization rate among COVID-19
patients is around 10%, of which approximately 40% develop Acute
Respiratory Distress Syndrome (ARDS). Death rates from COVID-19
appear to be driven by severe ARDS, with an average of 25% to 50%.
Fatality rate among hospitalized COVID-19 patients is an
approximate 20%.
8.Any other matters that need to be specified: 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.:
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