Acticor Biotech: Progress in Discussions with EU and US Regulatory Agencies
31 May 2023 - 2:30AM
Business Wire
- The FDA has provided valuable feedback to reinforce the
proposed clinical development plan of glenzocimab in acute ischemic
stroke (AIS)
- A new Type C consultation with the FDA has been granted on
the pharmaceutical development plan
- In Europe additional scientific advice requests under the
PRIME program have been validated by the EMA
- In ACTISAVE study, 300 patients have already been recruited
and 100 patients have been treated with thrombolysis and
thrombectomy, reaching the target for the first futility
analysis.
Regulatory News:
Acticor Biotech, (ISIN: FR0014005OJ5 - ALACT), a clinical stage
biopharmaceutical company developing glenzocimab, an innovative
drug for the treatment of cardiovascular emergencies, is discussing
with the FDA and the EMA its development program for the acute
ischemic stroke (AIS) indication.
In the US, Acticor Biotech was granted FDA Type C consultation
on its non-clinical and clinical developments for its
first-in-class drug candidate, glenzocimab. Written responses were
received by the end of May 2023 on a list of questions regarding
potential future marketing authorization (BLA) of glenzocimab in
AIS indication. The FDA provided valuable feedback to reinforce the
proposed development plan and to best address US requirements on
the expected design of a pivotal study. These recommendations will
be evaluated in an aim to adjust some parameters of the ongoing
ACTISAVE study, taking into account both US and EU opinions to
propose a single acceptable development plan up to
registration.
In parallel, a new FDA Type C consultation was granted on the
pharmaceutical development with written answers expected by end of
July 2023.
In Europe, Acticor continues to discuss the clinical and
pharmaceutical developments for registration with the EMA as part
of the PRIME designation program. Additional scientific advice
requests under this program have been validated by the EMA
including the pharmaceutical development plan.
As a reminder, the positive results of the ACTIMIS phase 1b/2a
clinical trial evaluating glenzocimab in combination with the
reference treatment (thrombolysis with or without thrombectomy) in
patients presenting with AIS demonstrated glenzocimab very
favorable safety profile by meeting the primary end-point of the
trial, as well as by showing a significant reduction in the number
of intracerebral hemorrhages and mortality in the group treated
with glenzocimab.
To date, the ACTISAVE study has enrolled more than 300 patients
across 10 countries in the world. Out of them, 100 have been
treated with thrombolysis with thrombectomy, reaching the target
for the first futility analysis. The Independent Data Meeting
Committee (IDMC) will gather in Q4 2023 to confirm safety and
ascertain that preliminary results are aligned with the initial
trial assumptions.
About ACTISAVE
ACTISAVE (NCT05070260) is a multinational, adaptive,
multicenter, randomized, double-blind, placebo-controlled,
parallel-group Phase 2/3 study evaluating the safety and efficacy
of a single dose of glenzocimab used in combination with standard
of care (thrombolysis +/- thrombectomy) for acute ischemic
stroke.
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), which is aiming to develop an innovative
treatment for cardiovascular emergencies, including ischemic
stroke.
The positive results from its Phase 1b/2a study, ACTIMIS,
confirmed the safety profile and showed a reduction in mortality
and intracerebral hemorrhage in the glenzocimab-treated group in
patients with stroke. The efficacy of glenzocimab is now being
evaluated in an international Phase 2/3 study, ACTISAVE, which will
include 1,000 patients. In July 2022, Acticor Biotech was granted
"PRIME" status by the European Medicines Agency (EMA) for
glenzocimab in the treatment of stroke. This designation will allow
the company to strengthen its interactions and obtain early
dialogues with regulatory authorities.
Acticor Biotech is supported by a panel of European and
international investors (Mediolanum farmaceutici, Karista, Go
Capital, Newton Biocapital, CMS Medical Venture Investment (HK)
Limited, A&B (HK) Limited, Anaxago, and the Armesa foundation).
Acticor Biotech is listed on Euronext Growth Paris since November
2021 (ISIN: FR0014005OJ5 – ALACT).
For more information, visit: www.acticor-biotech.com
Disclaimer
This press release contains certain forward-looking statements
concerning Acticor Biotech and its business. Such forward-looking
statements are based on assumptions that Acticor Biotech considers
to be reasonable. However, there can be no assurance that such
forward-looking statements will be verified, which statements are
subject to numerous risks, including the risks set forth in the
Document de référence registration document as approved by the
Autorité des marchés financiers under number R. 22-011 on 26 April
2022 and to the development of economic conditions, financial
markets and the markets in which Acticor Biotech operates. The
forward-looking statements contained in this press release are also
subject to risks not yet known to Acticor Biotech or not currently
considered material by Acticor Biotech. The occurrence of all or
part of such risks could cause actual results, financial
conditions, performance or achievements of Acticor Biotech to be
materially different from such forward-looking statements.
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ACTICOR BIOTECH Gilles AVENARD, MD CEO and Founder
gilles.avenard@acticor-biotech.com T. : +33 (0)6 76 23 38 13
Sophie BINAY, PhD General Manager and CSO
Sophie.binay@acticor-biotech.com T. : +33 (0)6 76 23 38
13
NewCap Mathilde BOHIN / Quentin MASSÉ Investor Relations
acticor@newcap.eu T. : +33 (0)1 44 71 94 95
NewCap Arthur ROUILLÉ Media Relations acticor@newcap.eu
T. : +33 (0)1 44 71 00 15
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