Valneva Initiates Phase 2
Clinical Development For Its Lyme Disease Vaccine Candidate
Saint-Herblain (France), December
17, 2018 - Valneva SE ("Valneva"), a biotech company developing and
commercializing vaccines for infectious diseases with major unmet
needs, today announced the initiation of the Phase 2 Clinical
Development for its leading, unique Lyme disease vaccine candidate
VLA15.
The overall Phase 2 objective for VLA15 is to determine the optimal
dosage level and schedule for use in Phase 3 pivotal field efficacy
studies, based on immunogenicity and safety data.
The Phase 2 development for the
Lyme disease vaccine candidate will include the evaluation of the
highest dose of VLA15 tested in Phase 1 in addition to two higher
doses. Furthermore, the company plans to include the evaluation of
an additional, alternative three-dose schedule.
Wolfgang Bender, MD, PhD, Chief
Medical Officer of Valneva, commented, "Lyme
disease cases in the U.S. have increased dramatically over the last
30 years or so, substantially increasing the costs for healthcare
systems. The fear of contracting Lyme disease diminishes the
quality of life of people of all ages. As the disease footprint
widens, the need for a vaccine to prevent this significant unmet
medical need increases. Valneva is doing everything possible, in
consultation with FDA and EMA, to develop a safe and effective
vaccine under the fast track designation."
The Phase 2 duration is expected
to be approximately two years with interim data (primary endpoint)
expected mid-2020.
About The Phase 2 Clinical Study
VLA15-201
VLA15-201 is the first of two planned, parallel Phase 2 studies. It
is a randomized, observer-blind, placebo controlled trial conducted
at trial sites in the US and Europe.
Initially, 120 subjects will receive one of three dosage levels of
VLA15, or placebo, followed by a Data Safety Monitoring Board
review of safety data. Thereafter, 450 subjects will receive one of
two dose levels of VLA15 (180 subjects each), or placebo (90
subjects), in the main study phase.
VLA15 will be tested as alum adjuvanted formulation and will be
administered intramuscularly in three injections, given at Days 1,
29 and 57. Subjects will be followed for one year, with the main
immunogenicity readout on Day 85 (Primary endpoint). The study is
enrolling healthy adults 18 to 65 years of age. Study centers will
be located in areas where Lyme disease is endemic; subjects with a
cleared past infection with Borrelia
burgdorferi, the bacteria that cause Lyme disease, will also be
enrolled.
About Lyme
Disease
Lyme disease is a systemic infection caused by Borrelia bacteria transmitted to humans by infected
Ixodes ticks[1]. It is
considered the most common vector borne illness in the Northern
Hemisphere. According to the U.S. Centers for Disease Control and
Prevention (CDC), approximately 300,000 Americans[2] are
diagnosed with Lyme disease each year with at least a further
200,000 cases in Europe[3]. Early
symptoms of Lyme disease (such as a gradually expanding
erythematous rash called Erythema migrans or
more unspecific symptoms like fatigue, fever, headache, mild stiff
neck, arthralgia or myalgia) are often overlooked or
misinterpreted. Left untreated, the disease can disseminate and
cause more serious complications affecting the joints (arthritis),
the heart (carditis) or the nervous system. The medical need for
vaccination against Lyme disease is steadily increasing as the
disease footprint widens[4].
About
VLA15
Valneva's vaccine candidate, VLA15, is currently the only active
vaccine program in clinical development against Lyme disease. The
program was granted Fast Track designation by the U.S. Food and
Drug Administration (FDA) in July 2017[5] and Valneva
reported positive interim Phase 1 results in March 2018[6]. VLA15
showed a favourable safety profile and was immunogenic in all doses
and formulations tested with good OspA-specific IgG antibody
responses against all OspA serotypes.
VLA15 is a multivalent, protein subunit vaccine that targets the
outer surface protein A (OspA) of Borrelia. It
is designed for prophylactic, active immunization against Lyme
disease aiming for protection against the majority of human
pathogenic Borrelia species. VLA15 is designed
to confer protection by raising antibodies that prevent Borrelia from migrating from ticks to humans after a
bite. The safety profile is expected to be similar to other
vaccines using the same technology that have been approved for
active immunization in adults and children.
The target population includes individuals at risk above 2 years of
age living in endemic areas, people planning to travel to endemic
areas to pursue outdoor activities and people at risk who have a
history of Lyme disease (as infection with Borrelia does not confer protective immunity against
all pathogenic Borrelia species).
Vaccination with OspA was already proven to work in the 1990s and
VLA15 pre-clinical data showed that the vaccine has the potential
to provide protection against the majority of the Borrelia species pathogenic for humans[7].
About Valneva
SE
Valneva is a biotech company developing and commercializing
vaccines for infectious diseases with major unmet needs. Valneva's
portfolio includes two commercial vaccines for travelers:
IXIARO®/JESPECT®
indicated for the prevention of Japanese encephalitis and
DUKORAL® indicated for
the prevention of cholera and, in some countries, prevention of
diarrhea caused by ETEC. The Company has various vaccines in
development including a unique vaccine against Lyme disease.
Valneva has operations in Austria, Sweden, the United Kingdom,
France, Canada and the US with over 450 employees. More information
is available at www.valneva.com.
Valneva Investor
and Media Contacts
Laetitia Bachelot-Fontaine
Global Head of Investor Relations &
Corporate Communications
M +33 (0)6 4516 7099
investors@valneva.com |
Teresa Pinzolits
Corporate Communications Specialist
T +43 (0)1 20620 1116
communications@valneva.com |
Forward-Looking
Statements
This press release contains certain forward-looking statements
relating to the business of Valneva, including with respect to the
progress, timing and completion of research, development and
clinical trials for product candidates, the ability to manufacture,
market, commercialize and achieve market acceptance for product
candidates, the ability to protect intellectual property and
operate the business without infringing on the intellectual
property rights of others, estimates for future performance and
estimates regarding anticipated operating losses, future revenues,
capital requirements and needs for additional financing. In
addition, even if the actual results or development of Valneva are
consistent with the forward-looking statements contained in this
press release, those results or developments of Valneva may not be
indicative of their in the future. In some cases, you can identify
forward-looking statements by words such as "could," "should,"
"may," "expects," "anticipates," "believes," "intends,"
"estimates," "aims," "targets," or similar words. These
forward-looking statements are based largely on the current
expectations of Valneva as of the date of this press release and
are subject to a number of known and unknown risks and
uncertainties and other factors that may cause actual results,
performance or achievements to be materially different from any
future results, performance or achievement expressed or implied by
these forward-looking statements. In particular, the expectations
of Valneva could be affected by, among other things, uncertainties
involved in the development and manufacture of vaccines, unexpected
clinical trial results, unexpected regulatory actions or delays,
competition in general, currency fluctuations, the impact of the
global and European credit crisis, and the ability to obtain or
maintain patent or other proprietary intellectual property
protection. In light of these risks and uncertainties, there can be
no assurance that the forward-looking statements made during this
presentation will in fact be realized. Valneva is providing the
information in these materials as of this press release, and
disclaim any intention or obligation to publicly update or revise
any forward-looking statements, whether as a result of new
information, future events, or otherwise.
[1] Stanek et al. 2012, The Lancet 379:461-473
[2] As estimated by the CDC,
https://www.cdc.gov/lyme/stats/humancases.html.
[3] Estimated from available national data. Number
largely underestimated based on WHO Europe Lyme Report as case
reporting is
highly inconsistent in Europe and many LB infections go
undiagnosed; ECDC tick-borne-diseases-meeting-report
[4] New Scientist, Lyme disease is set to explode and we still
don't have a vaccine; March 29, 2017
https://www.newscientist.com/article/mg23431195-800-lyme-disease-is-set-to-explode-and-you-cant-protect-yourself/
[5] http://www.valneva.com/en/investors-media/news/2018;
[6] Valneva
Press Release March 19, 2018: Valneva Reports Positive Phase I
Interim Results for Its Lyme Vaccine Candidate VLA15.
[7] http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0113294.
2018_12_17_VLA_Lyme_Ph2_Initiation_PR_EN
This
announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: VALNEVA via Globenewswire
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