Crossject announces publication of clinical data on ZEPIZURE ® in Neurology and Therapy
May 30 2024 - 3:30AM
Crossject announces publication of clinical data on ZEPIZURE ® in
Neurology and Therapy
Clinical study performed in 2022 now published in
peer-reviewed Neurology and Therapy
Further elaborates on bioequivalence demonstrated
versus European listed drug Dormicum®
Early onset can be expected thanks to early blood
concentration of midazolam with ZEPIZURE®
Low variability confirmed, a key advantage vs
other forms of administration, such as intranasal
Dijon, France May 30, 2024 -1030 am CET-
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®, announces the publication of clinical data in the
peer-reviewed journal Neurology and Therapy.
Seizures require urgent treatment when they last
longer than 5 minutes and when prolonged, can lead to damage to the
brain, coma, and ultimately death. Midazolam injected in the muscle
has become the first-line treatment of choice for long-lasting
seizures. ZEPIZURE®, based on the ZENEO® autoinjector and
previously known as ZENEO® Midazolam, provides for needle-free
delivery of midazolam with significant associated advantages.
The article now published outlines full results
of a clinical study conducted in 2022, demonstrating that ZENEO®
allows injecting midazolam intramuscularly, on bare skin or through
clothing, to the same extent as a syringe equipped with a 30mm
needle (Dormicum®), and with a 2-fold lower variability as compared
to that usually observed for routes of administration such as
intranasal. In addition, ZEPIZURE® enhanced the midazolam
absorption during the first minutes post-injection, suggesting that
seizure treatment may be efficient sooner. The safety profile,
level of pain and sedation were comparable to intramuscular syringe
injection. The maximum blood concentration reached with ZEPIZURE®
is not above that with Dormicum®, which is a good indication in
terms of safety.
“The ZENEO® needle-free auto-injector is an
innovative, prefilled, single-dose, ready-to-use, two-step device
that could become the best in-class device for midazolam
intramuscular administration in emergencies. Delivery of the full,
10mg dose in a safe manner, with low variability and in convenient
conditions, is a decisive advantage in emergency situations,” said
Olivier Lacombe, PhD, Director Pharmaceutical Development
of Crossject and lead author of the
article.
The 4-period, crossover and randomized study was
conducted on 40 healthy subjects, with gender, ethnicity and body
mass index diversity (ClinicalTrials.gov NCT05026567). Data
reported in November 2022 showed that the primary objective was met
in the trial, with the evaluation of the relative bioavailability
of midazolam after injection with the needle-free autoinjector
ZENEO® (10mg midazolam in 0.625mL). This was compared to injection
of Dormicum® (10mg midazolam in 2mL) by a conventional syringe with
a 30mm needle, into the thigh on bare skin.
“The detailed clinical results published today in Neurology and
Therapy on ZEPIZURE® are exciting, as they outline quick delivery
of a life-saving medicine,” said Patrick Alexandre, CEO of
Crossject.
Click here for the full article.
About Crossject
Crossject SA (Euronext:
ALCJ; www.crossject.com) is an emerging specialty pharma
company. It 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). ZEPIZURE® is based on the Company’s
award-winning needle-free autoinjector ZENEO®, designed to enable
patients and untrained caregivers to easily and instantly deliver
emergency medication via intramuscular injection on bare skin or
even through clothing. The Company’s other products in development
include rescue therapies for allergic shocks, adrenal
insufficiencies, opioid overdose and asthma attacks.
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 |
|
- Press release Neurology Therapy 29052024 _Final
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