Crossject elaborates on ZEPIZURE® potential in light of landmark RAMPART study and its own, recently published, bioequivalence study
26 Junio 2024 - 12:30AM
- Landmark RAMPART study established
midazolam intramuscular (IM) injection as a standard of care in the
pre-hospital emergency management of epilepsy crises compared to
traditional benzodiazepine intravenous (IV)
- Crossject’s bioequivalence study,
recently published in Neurology and Therapy, remarkably consistent
with RAMPART’s findings and authors’ views
Dijon, France 26 June, 2024 -- Crossject
(ISIN: FR0011716265; Euronext: ALCJ), a specialty pharma company in
advanced phases of development and registration for
ZEPIZURE®, its emergency treatment for the
management of epileptic crises based on its award-winning
needle-free auto-injector ZENEO®, provides additional, clinically
meaningful perspectives on ZEPIZURE® in light of its recently
published bioequivalence study results and of the conclusions and
hints by the authors of the RAMPART (Rapid
Anticonvulsant Medication
Prior to ARrival
Trial) study1, a landmark double-blind randomized
clinical trial comparing the efficacy of IM midazolam vs. IV
lorazepam in the pre-hospital treatment of status epilepticus by
paramedics. Status epilepticus is defined as a seizure lasting more
than 5 minutes.
RAMPART unequivocally raised IM midazolam to the
status of standard-of-care in the pre-hospital emergency management
of status epilepticus by demonstrating its non-inferiority vs. IV
lorazepam, as its primary endpoint. Moreover, IM midazolam
demonstrated statistically significant superiority (p
value<0.001) on the percentage of patients arriving in hospital
seizure-free, which was 10% higher when using IM midazolam (329 out
of 448 patients or 73.4% vs. 63.4% in the IV lorazepam 445-patient
arm). These results underscored the importance of the speed of IM
administration of midazolam, as an easy to store and pre-prepared
medication for use by paramedics, features that were likely
critical in driving efficacy in controlling seizures by the time of
arrival in emergency departments. RAMPART was one of the largest
studies every conducted in emergency settings, involving 4,314
paramedics, 33 EMS (Emergency Medical Services) units and 79
hospital ER (Emergency Room) departments across the U.S. It was
supported by the National Institute of Health (NIH) and by the
Biomedical Advanced Research and Development Authority (BARDA). The
RAMPART study publication can be found here.
Crossject’s study, recently published in the
peer-reviewed journal Neurology and Therapy, positively echoed the
benefits implied from RAMPART and is remarkably consistent with
certain hints put forward by the authors in the RAMPART study. In
Crossject’s study, ZEPIZURE® was equivalent to the IM injection
from a syringe equipped with a 30mm needle (Dormicum®), and results
also suggested a 2-fold lower variability as compared to that
usually observed for routes of administration such as
intranasal.
With some vision and based on their experience
then, RAMPART authors had highlighted a number of issues regarding
intranasal solutions in epileptic seizures in general, and their
prediction of the likely dominance of the IM route for the future.
Today, no intranasal solution is approved for the management of
status epilepticus. According to RAMPART’s authors, the upfront
minutes were critical factors in driving the 10% superiority of IM
midazolam, administered through traditional manual vial-form
injectable, in positive clinical outcome by ER arrival. ZEPIZURE®,
as an ultra-rapid two-step injection, strongly resonates in this
practical interventional reality and is likely to further improve
the speed of action by healthcare professionals and reliability in
injecting a full dose of midazolam. Furthermore, in Crossject’s
study, ZEPIZURE® enhanced the midazolam absorption during the very
first few minutes post-injection, possibly resulting from the
needle-free 50 milliseconds injection compared to manual IM and
suggesting that seizure treatment may be efficient even sooner.
Patrick Alexandre, CEO of
Crossject added: “Beyond the 505(b)(2) regulatory and
market gate for ZEPIZURE® into the arsenal available to healthcare
professionals in status epilepticus episodes, as potentially the
most rapid-to-use and lowest variability tool for the delivery of a
complete midazolam dose pre-hospital, our product presents
additional upside. ZEPIZURE®’s rapid and easy two-step application
should potentially require limited training compared to traditional
injectables, and its consistency in administering an effective dose
would confer a key advantage. ZEPIZURE® is therefore poised to
provide all patients, and their relatives or caregivers, with the
professional standard-of-pre-hospital-care solution anytime and
anywhere. Our team in Europe and the U.S. is now executing our
development strategy to materialize these broad prospects, aiming
to position ZEPIZURE® from a productivity contribution to
healthcare professionals toward a high impact solution for all
patients and families at risk of a broad range of epilepsy
seizures.”
About Crossject
Crossject SA (Euronext:
ALCJ; www.crossject.com) is an emerging specialty
pharmaceuticals company developing medicines for emergency
situations harnessing its award-winning needle-free auto-injector
ZENEO® platform. Crossject is in advanced regulatory development
for ZEPIZURE®, an epileptic rescue therapy, for which it has a $60
million contract* with the U.S. Biomedical Advanced Research and
Development Authority (BARDA). The Company’s versatile ZENEO®
platform is designed to enable patients or untrained caregivers to
easily and instantly deliver a broad range of emergency medicines
via intramuscular injection on bare skin or even through clothing.
The Company’s other products in development include mainly
solutions for allergic shocks and adrenal insufficiencies, as well
as therapies and other emergency indications.
* Contract no: 75A50122C00031 with the
Department of Health and Human Services; Administration for
Strategic Preparedness and Response; Biomedical Research and
Development Authority
For further information, please contact:
Investors Natasha DrapeauCohesion Bureau+41 76 823
75 27natasha.drapeau@cohesionbureau.com |
MediaSophie BaumontCohesion Bureau+33 6 27 74 74
49sophie.baumont@cohesionbureau.com |
|
1 Silbergleit et al. New England Journal of Medicine, February
2012. Clinicaltrials.gov NCT05026567
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