- Completion of ProTEct-MS Phase 2 Clinical trial of temelimab in
multiple sclerosis (MS) with Karolinska Institutet / Academic
Specialist Center of Stockholm
- Top line results confirmed for March 2022
- Net Cash position of €5.5 million as of December 31, 2021 with
financial visibility to Q1 2023, not including the first €3 million
payment from Swiss Federal Office of Public Health (FOPH) grant for
post-COVID project received in January 2022
Regulatory News:
GeNeuro (Euronext Paris: CH0308403085 - GNRO), a
biopharmaceutical company developing new treatments for
neurodegenerative and autoimmune diseases, such as multiple
sclerosis (MS), amyotrophic lateral sclerosis (ALS) and severe
neuropsychiatric consequences of COVID-19 (post-COVID), announced
today that it has completed its ProTEct-MS clinical trial. The
Company also reported its cash position as of December 31, 2021 and
provided a business update.
“Despite the continuing challenges posed by the COVID-19
pandemic, 2021 has been a key year for GeNeuro and the development
of our HERV platform,” said Jesús Martin-Garcia, CEO of
GeNeuro. “Having completed the last-patient’s last-visit
yesterday for our ProTEct-MS trial at the Karolinska Institutet and
the Academic Specialist Center (ASC) in Stockholm, Sweden, we
confirm that results will be available by the end of March of this
year. This will of course be a key milestone for the Company and
for MS patients.”
The ProTEct-MS trial has been conducted at the Center for
Neurology of ASC, the largest MS center in Sweden. The one-year
Phase 2 trial has enrolled 40 patients whose disability progresses
without relapses as they have previously received chronic
anti-CD20-Ab therapy with rituximab. Results are expected to
document the safety and tolerability of temelimab following higher
doses (up to 54mg/kg/month), as well as efficacy based on the
latest biomarkers associated with disease progression. Despite the
availability of effective treatments against acute inflammation and
relapses, about 80% of MS patients suffer from the progression of
their disability over time, which remains the key unmet medical
need in MS.
“With the completion of patient visits in the ProTEct-MS trial,
we now look forward to reporting out the efficacy and safety
results by the end of March,” commented Prof. David Leppert,
M.D., Chief Medical Officer of GeNeuro. “We would like to thank
all the trial participants for their time and commitment to this
important research effort, especially in the difficult
circumstances of the past two years. We are also very grateful for
the Karolinska/ASC team’s dedication and commitment as we now work
towards the disclosure of the results.”
OTHER PRODUCT DEVELOPMENT HIGHLIGHTS SINCE JANUARY 1,
2021
Post-COVID
During 2021, academic groups in Europe and North America
produced unexpected but key scientific evidence showing that
SARS-CoV-2 derepresses the expression of the pathogenic protein
HERV-W ENV ("W-ENV") in susceptible individuals. W-ENV, which is
temelimab's target in MS, has well documented pro-inflammatory and
pathogenic properties to nervous system cells. Its detection in
COVID-19 patients provides a biological rationale for the use of
GeNeuro’s temelimab as a novel therapeutic option against the
long-term neuropsychiatric syndromes experienced by COVID-19
patients months after their infection.
In December 2021, GeNeuro’s post-COVID initiative was one
of the four projects selected by the Swiss Federal Office of Public
Health (FOPH) to receive a grant of 6.7 million Swiss francs (€6.4
million). This grant will co-fund a Phase 2 clinical trial to treat
post-COVID patients with severe neurological and psychiatric
symptoms with temelimab, GeNeuro's anti-W-ENV antibody. "This
funding from the FOPH comes at a critical moment as it will allows
GeNeuro to try to bring a much-needed treatment to the patients
affected by neuropsychiatric syndromes post-COVID," added Jesús
Martin-Garcia.
Large-scale academic studies indicate that more than 10% of
people infected with SARS-CoV-2 do not fully recover and/or develop
new symptoms, with a high proportion of neurological and/or
psychiatric disorders. With more than 350 million confirmed cases
of COVID-19 worldwide, including more than 150 million in the US
and Western Europe, this problem is now recognized as a major
public health emergency, as it is affecting millions of people.
GeNeuro is at the forefront in tackling this problem, with a Phase
2 clinical trial expected to start in 1H2022.
Amyotrophic Lateral Disease
(ALS)
2021 also brought the results of the joint effort against
ALS initiated in 2017 by GeNeuro and the National Institute
of Neurological Disorders and Stroke (NINDS), part of the U.S.
National Institutes of Health (NIH). This joint NINDS/GeNeuro study
has shown a very convincing preclinical proof-of-concept using
GeNeuro’s anti HERV-K GNK01 monoclonal antibody. A new pathogenic
mechanism has been unveiled and characterized, and these results
open new perspectives for a biomarker-based therapeutic
intervention against sporadic ALS, which represents most cases of
this devastating disease affecting 10,000 new patients per year in
the US and EU, with a poor prognosis of survival. GeNeuro is
actively discussing paths with potential partners for the clinical
development of GNK01.
Cash position at December 31, 2021
As of December 31, 2021, GeNeuro had €5.5 million in cash and
cash equivalents and no debt. As mentioned above, this does not
include the first €3.0 million payment from the Swiss FOPH subsidy,
received in January 2022. Based on its planned activities and
operations, the Company estimates that its financial resources are
sufficient to cover its upcoming deadlines, operational expenses
and investments into Q1 2023.
“In these difficult times, securing our runway remains a
priority. In July 2021, we completed a € 6 million private
placement to extend GeNeuro’s financial visibility into 2023,
providing us sufficient time to facilitate Phase 3 planning and
partnering discussions following the results from our Phase 2
clinical trial of temelimab in MS at the Karolinska Institutet /
ASC in Stockholm,” said Miguel Payró, Chief Financial Officer at
GeNeuro. “Our cash balance at year-end 2021 covers our needs
into Q1 2023, excluding our planned post-COVID program which is to
be funded by the Swiss FOPH subsidy (of which we have received the
first tranche of €3 million in early January 2022) and other
dedicated financings.”
Continuing the trend observed during the 2020 financial year,
the cash consumption related to GeNeuro’s operating and investing
activities was reduced to €3.0 million in the second half of 2021,
compared to €3.7 million in the first half. Excluding the impact of
the planned post-COVID trial, cash consumption is expected to
further decrease during 2022 following the completion of the
Karolinska clinical trial.
Development of temelimab in Multiple Sclerosis (MS)
Temelimab’s one-year Phase 2 trial in MS with the Karolinska
Institutet has enrolled 40 patients whose disability progresses
without relapses and will document the safety and tolerability of
temelimab following higher doses, as well as efficacy based on the
latest biomarkers associated with disease progression. Patient
recruitment was completed in February 2021 and the last patient
visit was completed on January 25, 2022. Top-line results are
expected in March 2022.
Development of temelimab in post-COVID
GeNeuro has collaborated with various academic and research
centers on the interlink between SARS-CoV-2 and W-ENV. A first
publication in the Lancet EBioMedicine in April 2021 showed the
systematic presence of the pathogenic protein W-ENV in hospitalized
COVID-19 patients and its association with disease severity. Since
then, GeNeuro has been involved in numerous academic efforts to
understand the role of this W-ENV protein, which is known to have a
pro-inflammatory effect and pathogenicity on nervous system cells,
in the syndromes suffered by COVID-19 patients, months after the
infectious phase has ended. Today, GeNeuro is able to test the
presence of W-ENV in the blood of patients suffering from
Long-COVID, and is developing temelimab, a specific anti-W-ENV
antibody. The clinical trial supported by the FOPH will be a
double-blind, randomized, placebo-controlled, biomarker-based
clinical study on post-COVID patients with severe neuropsychiatric
symptoms that prevent them from continuing their daily and
professional activities.
Amyotrophic Lateral Sclerosis (ALS)
Beyond MS and Post-COVID, GeNeuro has continued to advance its
preclinical program in ALS in partnership with the NINDS (National
Institute of Neurological Disorders and Stroke, part of the U.S.
National Institutes of Health). The results of the joint
NINDS/GeNeuro study were presented in October 2021 at the American
Neurological Association congress, and at “The Lancet Summit:
Presymptomatic Prevention and Treatment of Neurodegenerative
Diseases” in December 2021. These show in vitro and in vivo the
neurotoxic effects specifically mediated by HERV-K ENV, a
retroviral envelope protein encoded by a pathogenic member of the
HERV-K family of endogenous human retroviruses (HERV-K ENV
protein). More importantly, they confirm the neutralizing effects
of GeNeuro’s novel specific monoclonal anti-HERV-K antibody. Thanks
to this research, a new pathogenic mechanism has been unveiled and
characterized, and these results open new perspectives for a
biomarker-based therapeutic intervention against sporadic ALS.
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
HERVs, which represent 8% of human DNA.
GeNeuro is based in Geneva, Switzerland and has R&D
facilities in Lyon, France. It has rights to 17 patent families
protecting its technology.
For more information, visit: www.geneuro.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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220126005832/en/
GeNeuro
Jesús Martin-Garcia
Chairman and CEO +41 22 552 4800 investors@geneuro.com
NewCap (France)
Louis-Victor Delouvrier / Mathilde Bohin (investors)
+33 1 44 71 98 52 Arthur Rouillé (media) +33 1 44 71 94 98
geneuro@newcap.eu
GeNeuro (EU:GNRO)
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