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GeNeuro Announces First Patient Treated in Phase 2a Study with GNbAC1 in Type 1 Diabetes

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GENEVA–()–Regulatory Information:

GeNeuro (Paris: GNRO), a biopharmaceutical firm creating new
remedies for autoimmune illnesses, announced at the moment that the primary
patient has been treated in its Australian Part 2a research of GNbAC1 in
sort 1 diabetes. This is GNbAC1’s second indication after a number of
sclerosis, for which a world Part 2b research is ongoing in 260

GNbAC1 is a monoclonal antibody designed to neutralize a pathogenic,
viral envelope protein, encoded by a human endogenous retrovirus (HERV).
HERVs are the results of ancestral, retroviral DNA insertions, presently
estimated to account for as much as eight% of the human genome. The humanized
IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env)
encoded by a member of the HERV-W family, the multiple
sclerosis-associated endogenous retrovirus (MSRV). This protein has been
detected in patients with multiple sclerosis and within the pancreas of
patients with sort 1 diabetes. It’s considered a causal issue of
these illnesses.

“We’ve been accumulating information that this pathogenic protein might
be a key issue in the improvement of autoimmune illnesses aside from
multiple sclerosis. The objective of this Part 2a research is to
show GNbAC1’s security and potential benefit in preserving
pancreatic perform in patients with sort 1 diabetes,”
stated François
Curtin Chief Working Officer of GeNeuro. “By concentrating on a
potential reason for sort 1 diabetes, GNbAC1 might result in a paradigm shift
for hundreds of thousands of sufferers all through the world.”

“The necessity for brand spanking new remedies for sort 1 diabetes could be very excessive.
Preclinical knowledge present that GNbAC1 offers an innovating and promising
strategy to deal with this necessary medical need. For this reason I’m
pleased with the launch of this medical research,”
Associate Prof. Richard W. Simpson, Japanese Medical Research Unit of
Monash College (Victoria, Australia), national investigator for the

This randomized, placebo-controlled Part 2a research will evaluate GNbAC1
in 60 just lately recognized grownup patients in over 10 facilities in Australia.
The incidence of sort 1 diabetes in Australia is among the many highest in
the world. The first endpoint is the security of GNbAC1 on this new
population of patients. Secondary endpoints will measure the link
between remedy response and MSRV-Env biomarkers of pancreatic
perform, insulin manufacturing based mostly on peptide C ranges, and different
biomarkers associated with sort 1 diabetes, akin to insulin consumption,
glycemia and manufacturing of diabetic auto-antibodies. Final patient
enrolment is predicted by the top of 2017 and preliminary outcomes are
anticipated through the third quarter 2018.

Jesús Martin-Garcia, Chairman and CEO of GeNeuro concluded: “We
welcome the remedy of our first affected person in the Part 2a research with
GNbAC1 in sort 1 diabetes, on monitor with our beforehand announced
schedule. The launch of this Part 2a research is a brand new vital
milestone for GeNeuro and for using GNbAC1 not only in a number of
sclerosis, but in addition in other autoimmune illnesses recognized to be related
with the presence of MSRV-Env protein.”

About Sort 1 Diabetes

Sort 1 diabetes, often first recognized in youngsters, is brought on by an
immune response directed towards the insulin producing cells of the
pancreas. In the USA alone, approx..1.8 million instances have
been recognized1. There isn’t a remedy for this autoimmune
disease, which suggests sufferers want life-long remedy with insulin
alternative. This remedy is usually related to a number of
debilitating problems, together with coronary heart disease, blindness, and
kidney disease, among others. The TD1 market represented $6.6bn
worldwide sales in 20131.

About GNbAC1

The development of GNbAC1 is the results of 25 years of analysis into
human endogenous retroviruses (HERVs), including 15 years at Institut
Mérieux and INSERM, a French nationwide medical analysis institute. Discovered
in the human genome, certain HERVs have been linked to varied
autoimmune illnesses. Researchers have demonstrated that the toxic Env
protein, related to MSRV (Multiple Sclerosis RetroVirus) and
identified in patients with MS, notably in lively lesions, and in
the pancreas of T1D patients. By neutralizing MSRV-Env, GNbAC1 might at
the same time block these pathological inflammatory processes and
restore remyelination in MS sufferers and keep insulin production in
T1D sufferers. As MSRV-Env has no recognized physiological perform, GNbAC1 is
expected to have a great security profile, with out affecting the patient’s
immune system, as noticed in all medical trials up to now.

About GeNeuro

GeNeuro‘s mission is to develop protected and effective remedies towards
neurological issues and autoimmune illnesses, corresponding to a number of
sclerosis, by neutralizing causal elements encoded by HERVs, which
symbolize eight% of human DNA.

GeNeuro is predicated in Geneva, Switzerland and has R&D amenities in France
at sites in Archamps, Haute-Savoie and in Lyon. It has 31 staff and
rights to 16 patent households defending its know-how.

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1 Source: GlobalData, Cowen & Company, The Environmental
Determinants of Diabetes in the Young

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