Crossject publishes clinical data on ZEPIZURE® in Neurology and Therapy

Crossject, a specialty pharmaceutical company, has published the results of a clinical study in the peer-reviewed journal Neurology and Therapy regarding their needle-free auto-injector, ZEPIZURE®. The study was conducted in 2022 and compared the bioequivalence of ZEPIZURE® to the European-listed drug Dormicum® in the treatment of epileptic seizures.

Seizures that persist beyond five minutes require immediate intervention to prevent severe brain damage, coma, or death. Midazolam, delivered intramuscularly, is the first-line treatment for such prolonged seizures. ZEPIZURE® utilizes Crossject's ZENEO® auto-injector technology to deliver midazolam without needles, offering several advantages over traditional methods.

The clinical study revealed that ZENEO® could administer midazolam intramuscularly through bare skin or clothing, achieving bioequivalence to Dormicum® delivered by a syringe with a 30mm needle. The variability in absorption was notably lower than that typically observed with intranasal routes, and the drug reached effective blood concentrations faster, potentially enabling quicker seizure control. The safety profile, pain levels, and sedation effects were comparable to traditional syringe injections. Importantly, the peak blood concentration of midazolam with ZEPIZURE® did not exceed that of Dormicum®, suggesting a favorable safety profile.

Olivier Lacombe, PhD, Director of Pharmaceutical Development at Crossject and lead author of the study, highlighted the innovative nature of the ZENEO® needle-free auto-injector. He emphasized that the device is prefilled, single-dose, ready-to-use, and involves a simple two-step process, making it ideal for emergency use. The ability to deliver a 10mg dose safely and with low variability in pressing conditions is a significant advantage.

The study was a four-period, crossover, and randomized trial involving 40 healthy participants of diverse gender, ethnicity, and body mass index. The trial’s primary objective was to assess the relative bioavailability of midazolam when injected using the ZENEO® device compared to Dormicum® via a syringe. Results showed that ZEPIZURE® met the primary endpoint, confirming its efficacy in delivering midazolam intramuscularly through the thigh on bare skin.

Patrick Alexandre, CEO of Crossject, expressed excitement over the detailed clinical results published in Neurology and Therapy, underscoring the quick delivery of a potentially life-saving medication.

About Crossject: Crossject is a burgeoning specialty pharmaceutical company listed on Euronext under the ticker symbol ALCJ. The company is in advanced stages of regulatory development for ZEPIZURE®, its emergency treatment for epileptic seizures, with a significant contract valued at $60 million from the U.S. Biomedical Advanced Research and Development Authority (BARDA). ZEPIZURE® is built on Crossject’s award-winning needle-free ZENEO® auto-injector, designed to allow easy and immediate administration of emergency medication intramuscularly, even through clothing. Crossject is also developing additional rescue therapies for conditions such as allergic shocks, adrenal insufficiencies, opioid overdoses, and asthma attacks.