Regulatory News:
ACTICOR BIOTECH (ISIN: FR0014005OJ5 – ALACT), a clinical
stage biotechnology company involved in the acute phase of
thrombotic diseases, today announces that the U.S Food and Drug
Administration (FDA) has provided clearance for the initiation of a
clinical trial in US with glenzocimab, a novel humanized monoclonal
antibody fragment, for use in patients with acute ischemic
stroke.
This active IND represents a significant milestone and marks the
launch in the US of the Phase 2/3 clinical trial with glenzocimab
in acute ischemic stroke as an add-on therapy to standard of care
for this indication.
“The development of new therapeutic options for the treatment of
the acute phase of ischemic stroke without increasing the bleeding
risk, is a major medical need of the coming years. The FDA
acceptance of an IND application for glenzocimab and the clinical
program that will be conducted by Acticor Biotech in the US
constitute important steps to offer new safe treatments to stroke
patients,” says Pr. James Grotta, M.D., Memorial Hermann
Hospital, Texas Medical Center, Global Coordinating Investigator
for ACTISAVE.
“We are very pleased with the achievement of this milestone
which materializes our clinical objective stated at the time of our
IPO which took place a few days ago, to enroll a first US patient
in Q1 2022, following the enrollment of a first patient in Europe
at the end of September 2021,” concluded Gilles Avenard, Chief
Executive Officer of Acticor Biotech.
ACTISAVE (NCT05070260) is an adaptive Phase 2/3
multinational, randomized, double-blind, multicenter,
placebo-controlled, parallel group, single dose, efficacy and
safety study, where patients are randomized to either 1000mg
glenzocimab or its matching placebo. Its primary objective is to
evaluate the efficacy of glenzocimab in addition to standard of
care, thrombolysis only or thrombolysis plus thrombectomy, with
specific focus on the Day 90 modified Rankin Scale score (mRS), for
acute ischemic stroke.
Started at the end of September 2021 in Europe, ACTISAVE follows
the end of recruitment of ACTIMIS study, a phase 1b/2a dose
escalation and safety study in 160 patients (NCT03803007), that
permitted the selection of the recommended dose of 1000 mg and the
confirmation of the favorable safety profile of glenzocimab
(complete results are expected by the first quarter of 2022). Eight
countries are expected to be involved with a total of 1000
patients. An initial futility analysis is planned after 200
patients have been enrolled.
About glenzocimab (ACT017), the Therapeutic Candidate
Acticor Biotech is developing glenzocimab (ACT017), a humanized
monoclonal antibody fragment (Fab). This therapeutic candidate is
directed against a novel target of major interest, platelet
glycoprotein VI (GPVI), and inhibits its action. Evidence of the
antithrombotic efficacy of glenzocimab and the safety of its
inhibition of GPVI has been established both ex vivo and in vivo.
This target is involved in growth of the thrombus but not in
physiological hemostasis, which thus limits the bleeding risk
associated with its inhibition.
https://acticor-biotech.com/ourproduct
About glenzocimab and COVID-19
Glenzocimab is also being assessed as a treatment for Acute
Respiratory Distress Syndrome (ARDS) in COVID-19-infected patients
(SARS-Cov-2) to contain the contribution of platelets to
uncontrolled lung inflammation and thus prevent downstream
complications due to pro-thrombotic conditions without inducing
bleeding. The primary objective of GARDEN (NCT04659109) study is to
evaluate the effect of glenzocimab in preventing the clinical
progression of disease when added to standard of care in COVID-19
patients presenting with ARDS. In July 2021, the 60 patients of the
study have been enrolled and complete results are expected by the
first quarter 2022.
About ACTICOR BIOTECH
Acticor Biotech is a clinical stage biopharmaceutical company, a
spin-off from INSERM (the French National Institute of Health and
Medical Research), that is developing an innovative treatment for
acute thrombotic diseases, including ischemic strokes.
At the end of October 2021, Acticor biotech has been awarded the
prix Galien Medstartup Award in the category “best collaboration in
the pharmaceutical or biotechnology industry” for its collaboration
with Pr James Grotta at the Memorial Hermann Hospital, TX.
Acticor Biotech is supported by a panel of European and
International Investors (Karista, Go Capital, Newton Biocapital,
CMS Medical Venture Investment (HK) Limited, A&B (HK) Limited,
Mirae Asset Capital, Anaxago, Primer Capital, Mediolanum
farmaceutici and the Armesa foundation). Acticor Biotech is listed
on Euronext Growth since November 2021 (ISIN: FR0014005OJ5 –
ALACT).
For further information, please go to
www.acticor-biotech.com
Forward-Looking Statements
Certain information included in this press release are not
historical facts but are forward-looking statements. These
forward-looking statements are based on current beliefs,
expectations and assumptions, including, without limitation,
assumptions regarding present and future strategy of Acticor
Biotech and the environment in which Acticor Biotech operates, and
involve known and unknown risks, uncertainties and other factors,
which may cause actual results, performance or achievements, or
industry results or other events, to be materially different from
those expressed or implied by these forward-looking statements.
These risks and uncertainties include those set out and detailed in
Chapter 3 “Risk Factors” of the registration document of Acticor
Biotech which was approved by the French Autorité des marchés
financiers on September 27, 2021 under number I.21-054.
Forward-looking statements speak only as of the date of this
press release and Acticor Biotech expressly disclaims any
obligation or undertaking to release any update or revisions to any
forward-looking statements included in this press release to
reflect any change in expectations or any change in events,
conditions or circumstances on which these forward-looking
statements are based. Forward-looking information and statements
are not guarantees of future performances and are subject to
various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Acticor Biotech. Actual
results could differ materially from those expressed in, or implied
or projected by, forward-looking information and statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20211104006138/en/
ACTICOR BIOTECH Gilles AVENARD, M.D. CEO and Founder
gilles.avenard@acticor-biotech.com
Sophie BINAY, PhD General Manager and CSO
Sophie.binay@acticor-biotech.com
NewCap Mathilde BOHIN / Olivier BRICAUD Investor Relations
acticor@newcap.eu Tel.: +33 (0)1 44 71 94 95
NewCap Annie-Florence LOYER Media Relations afloyer@newcap.fr
Tel.: +33 (0)1 44 71 00 12
Acticor Biotech (EU:ALACT)
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