Pardes Biosciences, Inc. (NASDAQ: PRDS), a clinical-stage
biopharmaceutical company developing a novel oral antiviral drug
candidate for the treatment of COVID-19, today reported topline
results from its Phase 2 clinical trial evaluating pomotrelvir for
the treatment of mild-to-moderate COVID-19 in test-positive,
symptomatic, otherwise healthy, vaccinated adults without risk
factors for developing severe disease. Pomotrelvir did not meet the
primary endpoint measured by the proportion of participants below
the limit of detection for infectious SARS-CoV-2 on day 3 of
treatment with pomotrelvir versus placebo. Otherwise healthy,
vaccinated adults without risk factors for progression to severe
disease experienced rapid clearance of SARS-CoV-2 virus and
evidence of rapid alleviation of targeted and key COVID-19 symptoms
independent of treatment arm. As a result of these data, the
Company has decided to suspend further development of pomotrelvir
and explore a range of strategic alternatives.
“We continue to believe in the need for new oral
antivirals for COVID-19, and the importance of continued investment
in next generation therapeutics that will be needed to help prevent
the next pandemic. However, these unexpected results have forced us
to make the difficult decision to suspend further development of
pomotrelvir and pursue alternative strategic opportunities for the
company,” said Thomas G. Wiggans, Chief Executive Officer and Chair
of Pardes Biosciences. “We are proud of the work done here at
Pardes Biosciences in pursuit of our mission and the breadth of
research assets and intellectual property we’ve generated along the
way. The team worked tirelessly, in the midst of an unprecedented
pandemic, to advance the science and accomplished remarkable things
in a short amount of time. Lastly, and most importantly, I want to
sincerely thank all of the participants and investigators involved
in the development of pomotrelvir for their support.”
Topline Phase 2 Results
Pomotrelvir did not achieve the primary endpoint as measured by
proportion of participants below the limit of detection for
infectious SARS-CoV-2 on day 3 by infectious virus assay (IVA) with
70% reaching undetectable levels in the pomotrelvir treated group
versus 63% in the placebo group (p=0.57). Pomotrelvir did not
demonstrate meaningful improvement over placebo in reduction from
baseline of SARS-CoV-2 infectious virus titer by IVA or in the
reduction from baseline or proportion achieving undetectable viral
load (RNA) by quantitative reverse transcriptase polymerase chain
reaction (qRT-PCR) measured from mid-turbinate swabs.
Table 1. SARS-CoV-2 Infectious Virus Titer and
Viral Load by Study Treatment and Visit through Day 5
|
|
Infectious Virus Titer (by IVA)[log10 TCID50/mL] |
Viral Load (RNA by qRT-PCR)[log10 copies/mL] |
|
|
Pomotrelvir |
Placebo |
Pomotrelvir |
Placebo |
|
N† |
53 |
|
32 |
|
153 |
|
77 |
|
Baseline |
|
2.0 |
|
2.1 |
|
5.3 |
|
5.1 |
|
Day 2 |
Mean change |
-1.0 |
|
-0.7 |
|
-0.7 |
|
-0.6 |
|
p-value |
0.11 |
0.47 |
Proportion negative |
45 |
% |
31 |
% |
17 |
% |
21 |
% |
p-value |
0.17 |
0.43 |
Day 3 |
Mean change |
-1.4 |
|
-1.3 |
|
-1.5 |
|
-1.0 |
|
p-value |
0.40 |
0.05 |
Proportion negative |
70 |
% |
63 |
% |
27 |
% |
26 |
% |
p-value |
0.57 |
0.81 |
Day 5 |
Mean change |
-1.6 |
|
-1.8 |
|
-2.6 |
|
-2.6 |
|
p-value |
0.78 |
0.79 |
Proportion negative |
96 |
% |
97 |
% |
46 |
% |
59 |
% |
p-value |
NE |
0.07 |
†N: Infectious virus titer assessments were
conducted on the modified intent-to-treat virology (mITTV) analysis
set, which is a subset of the modified intention to treat (mITT)
analysis set that includes participants who had detectable
infectious SARS-CoV-2 at Baseline/Day 1. Viral load assessments
were conducted on the mITT analysis set, which includes all
randomized participants with ≥ 2 symptoms consistent with COVID-19
≤ 5 days prior to randomization and a positive SARS-CoV-2 test
(qRT-PCR or RAT) ≤ 24 hours prior to randomization who received ≥ 1
dose of study drug.Mean change from Baseline: p-value = difference
between treatment groups by van Elteran testProportion negative:
For IVA = below limit of detection (LOD, 0.375 log10 TCID50/mL);
For viral load = undetectable RNA (1.24 log10 copies/mL); p-values
= standardized risk difference between treatment groups by
Mantel-Haenszel method (with adjustment for the following
stratification factors: SARS-CoV-2 positive direct test diagnosis
<= 3 days versus > 3 to 5 days from first onset of COVID-19
symptom(s))NE = not evaluable
There were no deaths and no participants
experienced progression to severe COVID-19. There were no
drug-related adverse events, serious adverse events, or adverse
events leading to discontinuation in either treatment arm.
Pomotrelvir was well tolerated, with treatment-emergent,
drug-related nausea occurring in 3.1% of participants, which
represented the only adverse event occurring in greater than 2% of
pomotrelvir-treated participants.
The median time to alleviation of the 14 U.S.
Food and Drug Administration guidance-defined and 12 (excluding
loss of taste and smell) targeted COVID-19 symptoms were 8 and 7
days, respectively, in both pomotrelvir and placebo treated
participants. Five predefined key COVID-19 symptoms of cough,
stuffy or runny nose, low energy or tiredness, sore throat, and
feeling hot or feverish were reported within a range of prevalence
of 89% to 60% of participants at baseline. The median time to
alleviation of all of these 5 key COVID-19 symptoms was 6 days in
both pomotrelvir and placebo treated participants; median times to
resolution of each individual key symptom ranged between 2 and 5
days, and were similar for both pomotrelvir and placebo treated
participants.
Overall, baseline levels of SARS-CoV-2
infectious virus and viral load were lower, clearance of infectious
virus was more rapid, and the speed of COVID-19 symptom improvement
was faster than anticipated when the study was designed. These are
important considerations when exploring the clinical benefit for
potential SARS-CoV-2 therapeutics at this stage of the COVID-19
pandemic, with high levels of underlying population immunity due to
vaccination plus ongoing community exposure to SARS-CoV-2 variants
resulting in the likelihood of more modest viral burden and acute
symptoms.
This study was conducted in otherwise healthy,
vaccinated adults without risk factors for progression to severe
disease with ≥ 2 symptoms consistent with COVID-19 for ≤ 5 days and
with a positive SARS-CoV-2 test (qRT-PCR or RAT) within 24 hours of
randomization. The majority (83%) of enrolled participants were
randomized to treatment within 3 days of COVID-19 symptom onset.
Participants received study drug treatment as soon as possible upon
randomization and were instructed to take the full 1400 mg total
daily dose of study drug on study day 1, followed by 700 mg
twice-daily, approximately every 12 hours, administered with food,
for a total of 5 days (10 doses).
The Company continues to analyze the results
from this study and intends to submit these data to a scientific
conference and/or peer-reviewed publication to contribute to the
understanding of SARS-CoV-2 and the development of potential
COVID-19 therapeutics.
Based on these results, the Company will suspend
further clinical development of pomotrelvir and the Company’s Board
of Directors has initiated a review of a range of strategic
alternatives that may include, but are not limited to, an
acquisition, merger, business combination, or other transaction.
There can be no assurance that this review process will result in
the Company pursuing a transaction or that any transaction, if
pursued, will be completed on attractive terms or at all. The
Company does not intend to comment further unless or until the
Board of Directors has approved a definitive course of action, the
review process is concluded, or it is determined that other
disclosure is appropriate. As of March 31, 2023, the Company’s
preliminary cash, cash equivalents and short-term investments
totaled approximately $172.4 million.
The Company’s unaudited financial statements for
the three months ended March 31, 2023 are not yet available.
Accordingly, the information presented reflects the Company’s
preliminary financial data subject to the completion of the
Company’s financial closing procedures and any adjustments that may
result from the completion of the quarterly review of the Company’s
financial statements. Actual financial results that will be
reflected in the Company’s Quarterly Report on Form 10-Q for the
three months ended March 31, 2023 when they are completed and
publicly disclosed may differ from the preliminary results
presented here.
About Study
PBI-0451-0002 (NCT 05543707) The Phase 2 double-blind,
randomized study enrolled 242 participants at 63 sites within the
United States and evaluated the antiviral activity, safety, and
clinical efficacy of pomotrelvir compared with placebo in
non-hospitalized, symptomatic, otherwise healthy adults from 18 to
65 years of age with mild-to-moderate COVID-19 and a confirmed
positive SARS-CoV-2 test. Participants were previously vaccinated
against SARS-CoV-2 and did not have medical conditions associated
with risk factors for severe illness. Due to the lack of drug-drug
interactions, the use of concomitant medications for underlying
health conditions was not restricted in this study. Participants
were randomized 2:1 to pomotrelvir or matching placebo dosed orally
twice-daily at 700 mg (2 x 350 mg tablets) with food for five
days.
This Phase 2 clinical trial was powered to
assess the primary endpoint of the proportion of participants below
the limit of detection for infectious SARS-CoV-2 on Day 3 of
treatment as measured by infectious virus assay from nasal swab
samples. Secondary objectives assessed included the dynamics and
time to negativity in SARS-CoV-2 viral load by both qRT-PCR and
rapid antigen testing, safety and tolerability, and clinical
efficacy through assessment of COVID-19 symptoms, hospitalizations
and deaths through Day 28.
About Pardes Biosciences,
Inc.Pardes Biosciences, Inc. is a clinical-stage
biopharmaceutical company focused on developing an oral antiviral
treatment for COVID-19. Following the suspension of its clinical
development activities, the Company is exploring a range of
strategic alternatives. For more information, please
visit www.pardesbio.com.
Availability of Other Information about
Pardes BiosciencesThe Company intends to use the Investors
page of its website (https://ir.pardesbio.com) as a means of
disclosing material non-public information and for complying with
its disclosure obligations under Regulation FD. Accordingly,
investors should monitor the Company’s Investors website, in
addition to following the Company’s press releases, U.S. Securities
and Exchange Commission (SEC) filings, public conference calls,
presentations and webcasts.
Forward Looking StatementsThis
press release contains statements that relate to future events and
expectations and, as such, constitute forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995. When or if used in this press release, the words
“believe,” “intend,” “may,” “plan,” “possible,” “predict,”
“should,” “will,” and similar expressions and their variants, as
they relate to the Company, may identify forward-looking
statements. All statements that reflect the Company’s expectations,
assumptions or projections about the future, other than statements
of historical fact, are forward-looking statements, including,
without limitation, statements regarding the Company’s preliminary
cash, cash equivalents and short-term investments as of March 31,
2023, the Company’s intent to review strategic alternatives and its
submission of clinical data to a scientific conference and/or peer
reviewed publication. Any forward-looking statements in this press
release are based on management’s current expectations and beliefs
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, risks associated with: the completion of the quarterly
review of the Company’s financial statements for the quarter ended
March 31, 2023; volatility and uncertainty in the capital markets
for biopharmaceutical companies; the Company’s ability to execute
its planned exploration and evaluation of strategic alternatives;
availability of suitable third parties with which to conduct
contemplated strategic transactions; whether the Company will be
able to pursue a strategic transaction, or whether any transaction,
if pursued, will be completed on attractive terms; whether the
Company’s plans will provide the intended benefits and cost
savings; and other risks and uncertainties described under the
heading “Risk Factors” in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2022 and other filings subsequently
filed with the SEC. The statements in this press release speak only
as of the date of this press release, even if subsequently made
available by the Company on its website or otherwise. The Company
disclaims any intention or obligation to update publicly any
forward-looking statements, whether in response to new information,
future events, or otherwise, except as required by applicable
law.
Investor Contacts:Patrick
O'Brienpobrien@pardesbio.com
Pardes Biosciences (NASDAQ:PRDS)
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