- Topline data from the Resolve™ Phase 3 trial did not meet
pre-specified efficacy objectives
- The attack rate for the Phase 3 primary objective was
approximately 25% of that observed in Phase 2 trial
- Topline data from our Phase 2 rollover trial suggest improved
vaccine efficacy from a second year of dosing
Management will host a conference call at
5:00 pm ET time today
Novavax, Inc., (Nasdaq:NVAX) today announced topline data from two
clinical trials of its RSV F-protein recombinant nanoparticle
vaccine candidate (RSV F Vaccine) in older adults. The
Resolve™ trial, a Phase 3 trial of our RSV F Vaccine in 11,856
older adults (60 years of age and older), did not meet the
pre-specified primary or the secondary efficacy objectives, and did
not demonstrate vaccine efficacy. Consistent with our previous
clinical experience, the vaccine was well tolerated.
Phase 3 Resolve™ Trial
The trial was a randomized, observer-blinded,
placebo-controlled trial conducted at 60 sites in the United
States. The primary objective of the Resolve trial was to
demonstrate efficacy in the prevention of moderate-severe
RSV-associated lower respiratory tract disease (RSV msLRTD), as
defined by the presence of multiple lower respiratory tract
symptoms. The secondary objective of the trial was to demonstrate
efficacy of the RSV F Vaccine in reducing the incidence of all
symptomatic respiratory disease due to RSV (RSV ARD). Finally, the
trial also evaluated the safety of the unadjuvanted, 135 microgram
dose of the RSV F Vaccine compared to placebo.
Topline efficacy results of the trial are shown
in the following table:
Summary of Primary and Secondary Objectives –
Vaccine Efficacy |
|
Number of Participants - ITT Population
(11,856) |
Primary and Secondary Objectives |
Placebo (5,935) |
Vaccine (5,921) |
Vaccine Efficacy (CI) |
P-Value |
Primary: RSV msLRTD, N(%) |
26 (0.44%) |
28 (0.47%) |
-7.9 % (-84, 37) |
0.78 |
Secondary: RSV ARD, N(%) |
117 (1.97%) |
102 (1.72%) |
12.6 % (-14, 33) |
0.32 |
“We are both surprised and disappointed by the
outcome of the Resolve trial, which we recently unblinded. Our
initial analyses and review of the key aspects of the trial do not
indicate issues with trial execution, data collection, data
integrity, or drug product quality. We expect to have preliminary
immunogenicity data in the coming weeks to further our
understanding of the trial results,” said Gregory Glenn M.D.,
President, Research and Development. “Historically, annual seasonal
RSV ARD attack rates between 3% and 7% have been observed in older
adults1. In our Phase 2 trial, we observed an RSV ARD attack rate
of 4.9% and an RSV msLRTD attack rate of 1.8%. In contrast, we
observed an RSV ARD attack rate of 2.0% and an msLRTD attack rate
of 0.4% in our Phase 3 trial. These attack rates indicate a mild
RSV season in older adults this year. We are continuing to
investigate potential root causes that could have impacted the
outcome of this trial. We continue to believe that there is a path
forward for our RSV vaccine and that there is an important unmet
need for an RSV vaccine in older adults.”
Phase 2 Rollover Trial
Novavax also reported topline results from the
Phase 2 rollover clinical trial of its RSV F Vaccine in older
adults.
The trial was a randomized, observer-blinded,
placebo-controlled rollover trial which enrolled 1,329 older adults
from the prior Phase 2 trial, conducted at the same 10 sites in the
United States. The primary objectives of the trial evaluated safety
and serum anti-F IgG antibody concentrations in response to
immunization with the RSV F Vaccine. The exploratory objectives of
the trial evaluated the efficacy of a second annual dose of the RSV
F Vaccine in the prevention of RSV ARD and RSV msLRTD. Participants
previously randomized to receive 135 microgram RSV F Vaccine or
placebo were re-enrolled and re-randomized in the current trial to
receive either 135 microgram RSV F Vaccine or placebo. This
resulted in analysis of four separate trial arms: a) participants
receiving a placebo in both the first trial and second trial; b)
participants receiving RSV F Vaccine in the first trial and placebo
in the second trial (Vaccine-Placebo); c) participants receiving
placebo in the first trial and RSV F Vaccine in the second trial
(Placebo-Vaccine); and d) participants receiving RSV F Vaccine in
both the first trial and second trial (Vaccine-Vaccine).
Topline results of the trial are shown in the
following tables:
Summary of Geometric Mean Titer for Anti-F by
Visit – ITT Population |
|
Number of Participants (1,329) |
|
Placebo (2014/15)
Placebo (2015/16) (N = 333) |
Vaccine (2014/15)Placebo
(2015/16) (N = 328) |
Placebo (2014/15)Vaccine
(2015/16) (N = 337) |
Vaccine (2014/15)Vaccine
(2015/16) (N = 331) |
Day 0 (baseline) N |
|
333 |
|
|
327 |
|
|
336 |
|
|
329 |
|
GMEU |
|
1012.8 |
|
|
2293.6 |
|
|
962.9 |
|
|
2267.3 |
|
95% CI |
|
(922.0,1112.5 |
) |
|
(2091.8, 2514.9 |
) |
|
(869.0,1067.0 |
) |
|
(2076.4, 2475.8 |
) |
|
Day 28 N |
|
332 |
|
|
325 |
|
|
333 |
|
|
327 |
|
GMEU |
|
1019.3 |
|
|
2188.7 |
|
|
6071.2 |
|
|
4489.3 |
|
95% CI |
|
(928.6, 1119.0 |
) |
|
(2005.0, 2389.2 |
) |
|
(5526.9, 6669.0 |
) |
|
(4137.7, 4870.7 |
) |
GMEU: geometric mean ELISA
units |
|
Gregory Glenn, M.D., said, “The rollover trial
demonstrated immunogenicity in all active vaccine recipients. As
shown in the table above, there was a 6-fold increase in anti-F IgG
in the Placebo-Vaccine arm, consistent with the Phase 2 efficacy
trial. There was higher anti-F IgG at baseline in the
Vaccine-Vaccine arm compared to the Placebo-Vaccine arm. Further,
the Vaccine-Vaccine arm showed a greater than 2-fold increase in
anti-F IgG from the higher baseline. We observed similar low attack
rates and absence of efficacy of a single immunization in this
trial as was observed in Phase 3 Resolve trial, although we did
observe that a second season immunization could provide efficacy.
The event rate comparisons made to either placebo groups suggested
that the second season immunization was protective, even in a year
with a very low attack rate. Further understanding of these data
may come forth with full evaluation of the immune responses.”
Summary of Exploratory Efficacy
Objective+ |
|
Number of Participants (1,329) |
|
Placebo (2014/15) Placebo
(2015/16)(N = 333) |
Vaccine (2014/15)Placebo
(2015/16) (N = 328) |
Placebo (2014/15)Vaccine
(2015/16) (N = 337) |
Vaccine (2014/15)Vaccine
(2015/16) (N = 331) |
RSV ARD (%) |
8 (2.4%) |
7 (2.1%) |
11 (3.3%) |
2 (0.6%)* |
RSV ARD Vaccine Efficacy |
|
|
11 |
% |
|
-36 |
% |
|
75 |
% |
msLRTD (%) |
1 (0.3%) |
2 (0.6%) |
2 (0.6%) |
|
0 |
|
*p-value = 0.079; msLRTD was not
calculated due to low N value |
+all data in table is not
significant (p-value > 0.05); preliminary N |
|
|
|
|
|
|
|
“While the results from the Resolve trial are
unexpected, we continue to believe in our technology and product
candidates based on the totality of the data from our RSV F Vaccine
franchise,” said Stanley C. Erck, President and CEO. “We expect to
gain a better understanding of the data from both the Phase 2
rollover and Phase 3 trials as we further analyze and review them
internally, as well as with our investigators and potential
partners. We intend to provide a more in-depth update at our
investor and analyst meeting on October 11, 2016.”
Conference call
Novavax management will host a conference call
at 5:00 p.m. ET. The dial-in number for the conference call is
877-212-6076 (U.S. or Canada) or 707-287-9331 (International),
passcode 80163880. A webcast of the conference call can also be
accessed via a link on the home page of the Novavax website
(novavax.com) or through the "Investor Info"/"Events" tab on the
Novavax website. Presentation slides will be available via
the webcast link.
A replay of the conference call will be
available starting at 7:30 p.m. on September 15, 2016 until
midnight September 20, 2016. To access the replay by telephone,
dial 855-859-2056 (Domestic) or 404-537-3406 (International) and
use passcode 80163880. The replay will also be available as a
webcast and can be found on the "Investor Info"/"Events" on the
Novavax website.
About RSV
Respiratory syncytial virus, commonly referred
to as RSV, is a respiratory infectious disease that causes serious
infection of the respiratory tract, similar to influenza. For some,
RSV may progress in severity, and lead to hospitalization or even
death. The spread of RSV occurs annually, with an incidence rate of
2.5 million infections per year in the United States, RSV is
increasingly being recognized as a significant cause of morbidity
and mortality in the population of 64 million older
adults.1,2 Each year, RSV is responsible for approximately
207,000 hospitalizations and 16,000 deaths among adults older than
65.3 Annually, there are approximately 900,000 medical
interventions directly caused by RSV disease.4,5 Currently,
there is no approved RSV vaccine available.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage
vaccine company committed to delivering novel products to prevent a
broad range of infectious diseases. Its recombinant nanoparticles
and Matrix-M™ adjuvant technology are the foundation for
ground-breaking innovation that improves global health through safe
and effective vaccines. Additional information about Novavax is
available on the company's website, novavax.com.
References1. A.R.
Falsey et al. Respiratory syncytial virus infection in
elderly and high-risk adults. N Engl J Med. 2005;
352:1749–59.
2. A.R. Falsey et al. Respiratory syncytial virus and
influenza A infections in the hospitalized elderly. J.
Infect Dis. 1995; 172:389-94.
3. K. Widmer et al. Rates of hospitalizations for
respiratory syncytial virus, human metapneumovirus, and influenza
virus in older adults. J Infect Dis. 2012; 206: 56-62.
4. K. Widmer et al. Respiratory syncytial virus & human
metapneumovirus-associated emergency department and hospital burden
in adults. Influenza and Other Respiratory Viruses. 2014;
8(3): 347-352.
Forward-Looking Statements
Statements herein relating to the future of
Novavax and the ongoing development of its vaccine and adjuvant
products are forward-looking statements. Novavax cautions that
these forward looking statements are subject to numerous risks and
uncertainties, which could cause actual results to differ
materially from those expressed or implied by such statements.
These risks and uncertainties include those identified under the
heading “Risk Factors” in the Novavax Annual Report on Form 10-K
for the year ended December 31, 2015 as filed with the Securities
and Exchange Commission (SEC). We caution investors not to place
considerable reliance on the forward-looking statements contained
in this press release. You are encouraged to read our filings with
the SEC, available at sec.gov, for a discussion of these and other
risks and uncertainties. The forward-looking statements in this
press release speak only as of the date of this document, and we
undertake no obligation to update or revise any of the statements.
Our business is subject to substantial risks and uncertainties,
including those referenced above. Investors, potential investors,
and others should give careful consideration to these risks and
uncertainties.
Contact:
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Associate Director, Investor Relations
ir@novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull@russopartnersllc.com
todd.davenport@russopartnersllc.com
212-845-4271
Novavax (NASDAQ:NVAX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Novavax (NASDAQ:NVAX)
Historical Stock Chart
From Sep 2023 to Sep 2024