ALCJ Crossject

Press release

CLINICAL DEMONSTRATION OF ZENEO® EFFICIENCY FOR INTRAMUSCULAR INJECTION OF MIDAZOLAM

• Primary endpoints met and results in line with expectations• No impact of clothing on the intramuscular injection with ZENEO®

Dijon, November 2, 2022 at 8am

CROSSJECT (ISIN: FR0011716265; Mnémo: ALCJ), a specialty pharma company that is developing and will soon be marketing a portfolio of drug / device combinations for use in emergency situations, is releasing positive headline results of its clinical study with ZENEO® midazolam. The 4-period, crossover and randomized study was conducted on 40 healthy subjects, with gender, ethnicity and BMI1 diversity (ref ClinicalTrials.gov Identifier NCT05026567).

The primary objective was met. It was the evaluation of the relative bioavailability of midazolam after injection with the needle-free autoinjector ZENEO® (10mg midazolam in 0.625mL) compared to injection of DORMICUM® (10mg midazolam in 2mL) by a conventional syringe with a 30mm needle, into the thigh on bare skin. The bioequivalence was achieved both on Cmax2 and on AUC3, with no change of Tmax4. The 90% Confidence Intervals were respectively of [84-98] for Cmax ratio, and [100-108] for AUC ratio.

No serious adverse events were reported, and there was no difference in safety profile between the tested conditions. Only 2 subjects dropped out before their fourth and last injection, not for safety but for personal reason.

As secondary objectives, the study aimed to test the intramuscular injection of midazolam with ZENEO® into thigh through clothing, compared to injection into thigh on bare skin with ZENEO® and with DORMICUM®. The 90% Confidence Intervals were respectively of [87-101] and [79-92] for Cmax ratios, and [87-95] and [91-98] for AUC ratios, with no change in Tmax. These results allow considering a much faster emergency treatment, without having to remove patient’s clothing in an epileptic seizure situation.

In addition, an intramuscular injection with ZENEO® midazolam in the ventrogluteal site was shown to be bioequivalent to an injection in the thigh on bare skin either with a conventional syringe or with ZENEO®.

Finally, ZENEO® and the syringe with intramucular needle showed a similar and low inter-subject variability of midazolam pharmacokinetics. This is an additional demonstration that an injection with ZENEO reached the muscle in the same way as an injection with a syringe and a 30 mm needle.

As a summary, the outcomes of this clinical study are a great achievement for Crossject, as they demonstrate the effectiveness of an intramuscular injection with the needle-free autoinjector ZENEO® into thigh with or without clothing, as well as into the ventrogluteal site.

Contacts :

About CROSSJECT • www.crossject.com

CROSSJECT (ISIN: FR0011716265; Ticker: ALCJ; LEI: 969500W1VTFNL2D85A65) is developing and is soon to market a portfolio of drugs dedicated to emergency situations: epilepsy, overdose, allergic shock, severe migraine and asthma attack. Thanks to its patented needlefree self-injection system, Crossject aims to become the world leader in self-administered emergency drugs. The company has been listed on the Euronext Growth market in Paris since 2014; it receives funding from the United States BARDA (Biomedical Advanced Research and Development Authority) and from Bpifrance. 

1 BMI : Body Mass Index, a measure of a person's thickness or thinness2 Cmax: maximum blood Concentration of the drug3 AUC : Area Under the Curve reflecting blood levels of a drug over time, an indication of the dose received4 Tmax : time to reach Cmax

Attachment

• PR_CROSSJECT_Clinical_demo_ZENEO 01112022

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