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 VLA15Valneva'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 SEValneva 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 ContactsLaetitia Bachelot-FontaineGlobal Head of Investor
Relations & Corporate CommunicationsM +33 (0)6 4516
7099investors@valneva.com |
Teresa
PinzolitsCorporate Communications SpecialistT +43 (0)1 20620
1116communications@valneva.com |
Forward-Looking StatementsThis 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.pdf
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