Vir Biotechnology Announces Topline Data from Phase 2 PENINSULA Trial Evaluating VIR-2482 for the Prevention of Seasonal Influenza A Illness
July 20 2023 - 8:00AM
Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the
Phase 2 PENINSULA
(
Prev
Entio
N
of
Ill
Nes
S D
Ue
to Inf
Luenza
A) trial evaluating
VIR-2482 for the prevention of symptomatic influenza A illness did
not meet primary or secondary efficacy endpoints. In participants
who received the highest dose of VIR-2482 (1,200 mg), a
non-statistically significant reduction of approximately 16% in
influenza A protocol-defined illness was observed. Participants who
received the highest dose showed an approximately 57% reduction in
symptomatic influenza A illness, when defined according to CDC
influenza-like-illness criteria, which was one of two secondary
endpoints. VIR-2482 was generally well tolerated and no safety
signals were identified.
PENINSULA (NCT05567783) is the first Phase 2
outpatient trial to evaluate the role of a monoclonal antibody in
the prevention of influenza A illness. The dose-ranging,
proof-of-concept trial enrolled approximately 3,000 men and women
ages 18 to 64 without risk factors for serious complications from
an influenza infection who did not receive an influenza vaccination
for the flu season. The primary efficacy endpoint was the
proportion of trial participants with protocol-defined
influenza-like-illness1 with PCR-confirmed influenza A infection
compared to placebo. Secondary endpoints included the proportion of
participants with CDC-defined influenza-like-illness2 with
PCR-confirmed influenza A infection and the proportion of
participants with WHO-defined influenza-like-illness3 with
PCR-confirmed influenza A infection.
“Although, these topline data are disappointing,
further analysis is necessary to better understand these outcomes,
which we plan to present at a major medical congress,” said Phil
Pang, M.D., Ph.D., Vir’s Executive Vice President, Chief Medical
Officer and Interim Head of Research. “In the meantime, we are
continuing to advance next generation solutions for serious
respiratory infections, including VIR-2981, an investigational
neuraminidase-targeting monoclonal antibody against both influenza
A and B viruses.”
“We are grateful to all who participated in this
trial, and we remain committed to the pursuit of novel therapies
that have the potential to address some of the world’s most serious
infectious diseases,” said Marianne De Backer, M.Sc., Ph.D.,
MBA, Vir’s Chief Executive Officer. “I’m very excited about
the future ahead, with the opportunities that we have, including a
robust pipeline, where we expect two data readouts across our
hepatitis B and hepatitis D programs in 2023. We also have a strong
balance sheet with approximately $1.9 billion in cash and
investments, as of the end of the second quarter, which will allow
us to invest in our ongoing development and future innovation.”
The Company plans to host a Second Quarter 2023
Results conference call on Thursday, Aug. 3, during which these
results will be discussed.
Efficacy AnalysesOccurrence of
Influenza-Like-Illness (ILI) with PCR-Confirmed Influenza
A
|
# of Participants with Endpoint/VIR-2482 vs. Placebo |
PlaceboN = 983n (%) |
VIR-2482 450 mgN = 981n (%) |
VIR-2482 1,200 mgN = 992n (%) |
PrimaryEndpoint |
Number of ParticipantsProtocol-Defined ILI1 |
25 (2.54%) |
24 (2.45%) |
21 (2.12%) |
Relative Risk Reduction (%) |
- |
3.78% |
15.85% |
95% CI (%) |
- |
-67.23, 44.63 |
-49.27, 52.56 |
p-value |
- |
0.89 |
0.56 |
SecondaryEndpoints |
Number of Participants with CDC-Defined ILI2 |
17 (1.73%) |
15 (1.53%) |
7 (0.71%) |
Relative Risk Reduction (%) |
- |
11.45% |
57.23% |
95% CI (%) |
- |
-76.25, 55.51 |
-2.51, 82.15 |
Number of Participants with WHO-Defined ILI3 |
11 (1.12%) |
12 (1.22%) |
6 (0.60%) |
Relative Risk Reduction (%) |
- |
-9.80% |
44.13% |
95% CI (%) |
- |
-147.41, 51.27 |
-50.49, 79.26 |
Note: Percentages are calculated relative to the
number of participants in the full analysis set.1 Protocol-defined
ILI is defined as PCR-confirmed influenza A infection with at least
one respiratory symptom: sore throat, cough, sputum production,
wheezing, or difficulty breathing and at least one systemic
symptom: fever (temperature >37.8°C), chills, weakness, or
myalgias.2 CDC-ILI is defined as fever (temperature >37.8°C) and
cough and/or sore throat.3 WHO-ILI is defined as fever (temperature
>38°C) and cough.
The PENINSULA trial has been supported in
whole or in part with federal funds from the Department of Health
and Human Services; Administration for Strategic Preparedness and
Response (ASPR); Biomedical Advanced Research and Development
Authority (BARDA), under Other Transaction Number:
75A50122C00081.
About VIR-2482VIR-2482 is an
investigational hemagglutinin targeting, intramuscularly
administered influenza A-neutralizing monoclonal antibody. In
vitro, it has been shown to cover all major strains of influenza A
that have arisen since the 1918 flu pandemic. VIR-2482 is designed
as a prophylactic for influenza A. It has the potential to address
the limitations of current flu vaccines due to its broad strain
coverage and because it does not rely on an individual to create
their own protective antibody response. VIR-2482, which
incorporates Xencor’s Xtend™ technology, also has been half-life
engineered so that a single dose has the potential to last the
entire flu season. Under the collaboration agreement signed with
GSK in 2021, GSK has an exclusive option to lead post-Phase 2
development and commercialization of VIR-2482.
About VIR-2981VIR-2981 is an
investigational neuraminidase-targeting monoclonal antibody against
influenza viruses. It targets a region of the neuraminidase protein
that is highly conserved across influenza A and B strains and is
designed to inhibit the influenza neuraminidase, a key viral
protein that facilitates release of new viruses in infected
individuals. Preclinical data demonstrate the antibody’s breadth
and potency against all major strains of seasonal and pandemic
influenza viruses and support the potential of this antibody in the
prevention of influenza illness.
About Vir BiotechnologyVir
Biotechnology is a commercial-stage immunology company focused on
combining immunologic insights with cutting-edge technologies to
treat and prevent serious infectious diseases. Vir has assembled
four technology platforms that are designed to stimulate and
enhance the immune system by exploiting critical observations of
natural immune processes. Its current development pipeline consists
of product candidates targeting hepatitis B and D viruses,
influenza A, human immunodeficiency virus and COVID-19. Vir
routinely posts information that may be important to investors on
its website.
Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Words such as “may,” “will,” “plan,” “potential,” “aim,” “expect,”
“anticipate,” “promising” and similar expressions (as well as other
words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
These forward-looking statements are based on Vir’s expectations
and assumptions as of the date of this press release.
Forward-looking statements contained in this press release include,
but are not limited to, statements regarding Vir’s strategy and
plans, the potential benefits of VIR-2482 to protect against
influenza A illness; the potential benefits of VIR-2981; the
expected timing of two data readouts across Vir’s hepatitis B and
hepatitis D programs; Vir’s cash balance, Vir’s future financial
and operating results and its expectations related thereto;
statements regarding Vir’s scientific and executional expertise,
and risks and uncertainties associated with drug development and
commercialization. Many factors may cause differences between
current expectations and actual results, including the occurrence
of adverse safety events; risks of unexpected costs, delays or
other unexpected hurdles; difficulties in collaborating with other
companies; successful development and/or commercialization of
alternative product candidates by Vir’s competitors; changes in
expected or existing competition; delays in or disruptions to Vir’s
business or clinical trials due to the COVID-19 pandemic,
geopolitical changes or other external factors; and unexpected
litigation or other disputes. Drug development and
commercialization involve a high degree of risk, and only a small
number of research and development programs result in
commercialization of a product. Results in early-stage clinical
trials may not be indicative of full results or results from
later-stage or larger scale clinical trials and do not ensure
regulatory approval. You should not place undue reliance on these
statements, or the scientific data presented. Other factors that
may cause actual results to differ from those expressed or implied
in the forward-looking statements in this press release are
discussed in Vir’s filings with the U.S. Securities and Exchange
Commission, including the section titled “Risk Factors” contained
therein. Except as required by law, Vir assumes no obligation to
update any forward-looking statements contained herein to reflect
any change in expectations, even as new information becomes
available.
Contacts:
Media
Carly Scaduto
Senior Director, Media Relations
cscaduto@vir.bio
+1-314-368-5189
Investors
Sasha Damouni Ellis
Executive Vice President, Chief Corporate Affairs Officer
sdamouni@vir.bio
Vir Biotechnology (NASDAQ:VIR)
Historical Stock Chart
From Apr 2024 to May 2024
Vir Biotechnology (NASDAQ:VIR)
Historical Stock Chart
From May 2023 to May 2024