Novavax Announces Topline RSV F Vaccine Data from Two Clinical Trials in Older Adults
(Thomson Reuters ONE) -
* Topline data from the Resolve(TM) 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
GAITHERSBURG, Md., Sept. 15, 2016 (GLOBE NEWSWIRE) -- 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(TM) 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(TM) 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 | Placebo | Vaccine | Vaccine |P-Value|
|Objectives | (5,935) | (5,921) | Efficacy (CI) | |
+--------------------------+-----------+-----------+----------------+-------+
|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) | Vaccine |Placebo (2014/15) | Vaccine |
| | Placebo | (2014/15) |Vaccine (2015/16) | (2014/15) |
| | (2015/16) | Placebo | (N = 337) | Vaccine |
| | (N = 333) | (2015/16) | | (2015/16) |
| | | (N = 328) | | (N = 331) |
+------------+------------------+-------------+------------------+-------------+
|Day 0 | 333 | 327 | 336 | 329 |
|(baseline) | | | | |
|N | | | | |
+------------+------------------+-------------+------------------+-------------+
| GMEU| 1012.8 | 2293.6 | 962.9 | 2267.3 |
+------------+------------------+-------------+------------------+-------------+
| 95% CI| (922.0,1112.5 )| (2091.8, )| (869.0,1067.0 )| (2076.4, )|
| | | 2514.9 | | 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, )| (5526.9, )| (4137.7, )|
| | | 2389.2 | 6669.0 | 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 | Vaccine | Placebo | Vaccine |
| | (2014/15) | (2014/15) | (2014/15) | (2014/15) |
| | Placebo | Placebo | Vaccine | Vaccine |
| | (2015/16) | (2015/16) | (2015/16) | (2015/16) |
| | (N = 333) | (N = 328) | (N = 337) | (N = 331) |
+---------------+-----------------+--------------+--------------+--------------+
|RSV ARD (%) | 8 (2.4%) | 7 (2.1%) | 11 (3.3%) | 2 (0.6%)* |
+---------------+-----------------+--------------+--------------+--------------+
|RSV ARD Vaccine| | 11 % | -36 % | 75 % |
|Efficacy | | | | |
+---------------+-----------------+--------------+--------------+--------------+
|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(TM) 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.
References
1. 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(at)novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull(at)russopartnersllc.com
todd.davenport(at)russopartnersllc.com
212-845-4271
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novavax, Inc. via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 15.09.2016 - 22:29 Uhr
Sprache: Deutsch
News-ID 495159
Anzahl Zeichen: 17204
contact information:
Town:
Maryland
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 201 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Novavax Announces Topline RSV F Vaccine Data from Two Clinical Trials in Older Adults"
steht unter der journalistisch-redaktionellen Verantwortung von
Novavax, Inc. (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
