[May 31, 2016] |
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GeNeuro Announces First Patients Treated in Phase 2b Study for Multiple Sclerosis
GeNeuro (Euronext Paris: CH0308403085 - GNRO), a biopharmaceutical
company developing new treatments for autoimmune diseases including
multiple sclerosis (MS), today announced that the first patients have
been treated with its lead product, GNbAC1, in a Phase IIb study in
relapsing-remitting multiple sclerosis (RRMS).
GNbAC1, the first drug candidate in clinical studies directly targeting
a potential cause of MS, is a monoclonal antibody designed to neutralize
MSRV-Env, a protein linked to the inflammatory and neurodegenerative
components of the disease.
"The aim of this Phase 2b study is to demonstrate the efficacy of GNbAC1
as a treatment for MS patients. This new therapeutic approach, targeting
MSRV-Env, seeks to neutralize an upstream source of inflammation and to
restore the remyelination capacity of the brain," explained François
Curtin, MD, Chief Operating Officer at GeNeuro. "Blocking a causal
factor in MS, as opposed to current treatments that interfere with the
immune system, would open a new therapeutic option for MS patients."
The double-blind, placebo-controlled study, CHANGE-MS (Clinical
trial assessing the HERV-W Env Antagonist GNbAC1
for Efficacy in Multiple Sclerosis) plans
to enroll 260 patients in 69 clinical centers in 13 European countries.
The primary endpoint will examine the cumulative number of active brain
lesions determined by MRI after 6 months, followed by additional MRI and
clinical measures at 12 months. Preliminary results are expected by
fourth quarter 2017.
CHANGE-MS is fully funded through a €362.5 million1 partnership
with Servier signed in 2014, in which Servier is involved in the
development and potential commercialization of GNbAC1 in MS in
territories ex USA and Japan.
"Meeting this clinical milestone, the first since raising €33 million in
our IPO in Paris in April 2016, is an important step in the development
of GNbAC1 in MS with Servier. The successful IPO will now allow GeNeuro
to extend MS studies of GNbAC1 into the US, where GeNeuro has kept all
the rights, and initiate trials in other autoimmune diseases, including
type-1 diabetes and CIDP (chronic inflammatory demyelinating
polyneuropathy), an orphan neurological disease" stated Jesús
Martin-Garcia, CEO of GeNeuro.
About Multiple Sclerosis
Multiple sclerosis (MS) is an autoimmune disease affecting approximately
2.5 million people worldwide, according to the Multiple Sclerosis
Foundation. Driven by inflammatory and neuro-degenerative processes, MS
damages the myelin sheath, the material that surrounds and protects
nerve cells, resulting in axonal damage in the brain and spinal cord.
This slows down or blocks nervous conduction between the brain and the
body, which leads to the symptoms of MS.
About GNbAC1 The development of GNbAC1 is the result of 25
years of research into human endogenous retroviruses (HERVs), including
15 years with the Mérieux Institute and INSERM, before GeNeuro was
founded in 2006. Found in the human genome, certain HERVs have been
linked to various autoimmune diseases. Specifically, MSRV-ENV, which is
found on the active lesions of MS patients, has been shown to have both
a pro-inflammatory action via interaction with the TLR4 receptor of
innate immunity, as well as to stop the differentiation of
oligodendrocyte precursor cells, which are responsible for remyelinating
brain lesions. By neutralizing MSRV-ENV, GNbAC1 could block a key factor
promoting the inflammation on the plaques, as well as allowing the
remyelination repair process to restart. As MSRV-ENV has no known
physiological function, GNbAC1 is expected to have a good safety
profile, without affecting the patient's immune system, as observed in
all clinical trials to date.
About GeNeuro GeNeuro's mission is to develop safe and
effective treatments against neurological disorders and autoimmune
diseases such as multiple sclerosis by neutralizing causal factors
encoded by human endogenous retroviruses (HERV), which represent 8% of
the human DNA; a new frontier pioneered by GeNeuro since 2006 based on
15 years of R&D at Institut Mérieux and INSERM.
GeNeuro is based in Geneva, Switzerland and has R&D facilities in
Archamps, Haute-Savoie and Lyon. It has 23 employees and rights to 16
patent families protecting its technology.
For more information, visit: www.geneuro.com
About Servier Servier is an independent French-based
pharmaceutical company with a strong international presence in 148
countries. It employs more than 21,000 people. Its development is driven
by the pursuit of innovation in the therapeutic areas of cancer,
cardiovascular, metabolic, central nervous system, psychiatric, bone,
muscle and joint diseases. In 2015, the company recorded a turnover of
€3.9 billion. 28% of this turnover was reinvested in Research and
Development.
For more information, visit: www.servier.com
Disclaimer This press release contains certain forward -
looking statements and estimates concerning GeNeuro's financial
condition, operating results, strategy, projects and future performance
and the markets in which it operates. Such forward-looking statements
and estimates may be identified by words such as "anticipate,"
"believe," "can," "could," "estimate," "expect," "intend," "is designed
to," "may," "might," "plan," "potential," "predict," "objective,"
"should," or the negative of these and similar expressions. They
incorporate all topics that are not historical facts. Forward looking
statements, forecasts and estimates are based on management's current
assumptions and assessment of risks, uncertainties and other factors,
known and unknown, which were deemed to be reasonable at the time they
were made but which may turn out to be incorrect. Events and outcomes
are difficult to predict and depend on factors beyond the company's
control. Consequently, the actual results, financial condition,
performances and/or achievements of GeNeuro or of the industry may turn
out to differ materially from the future results, performances or
achievements expressed or implied by these statements, forecasts and
estimates. Owing to these uncertainties, no representation is made as to
the correctness or fairness of these forward-looking statements,
forecasts and estimates. Furthermore, forward-looking statements,
forecasts and estimates speak only as of the date on which they are
made, and GeNeuro undertakes no obligation to update or revise any of
them, whether as a result of new information, future events or
otherwise, except as required by law.
1 Maximum value, excluding royalties, dependent on achieving
development milestones.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160531006239/en/
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