First injections of ZENEO® Midazolam for the clinical bioequivalence study

1 Press release First injections of ZENEO® Midazolam for the clinical bioequivalence study Dijon, 24 May 2022 CROSSJECT (ISIN: FR0011716265; Ticker: ALCJ), a specialty pharma company developing and soon to market a portfolio of drugs for use in emergency situations, announces the first injections of ZENEO® Midazolam for the clinical bioequivalence study. Patrick Alexandre, Crossject CEO, said: “We are pleased to announce that the pivotal clinical study for ZENEO® Midazolam has begun. This is an important step, as it is part of the evaluation of the marketing authorisation application. The results are expected in the autumn.” Crossject is beginning its clinical bioequivalence study for ZENEO® Midazolam with the first injections. The resulting data will be presented in the Marketing Authorisation Application (MAA) file. The objective of the study is to compare the plasma concentration of a ZENEO® Midazolam injection in healthy subjects with that of a syringe fitted with a conventional intramuscular needle filled with the regulatory reference drug midazolam. As a reminder, the previous clinical bioequivalence study for ZENEO® Methotrexate1 demonstrated the equivalence of subcutaneous injection. The two main criteria used to assess bioequivalence are (i) the area under the curve (AUC) – i.e. the dose of drug received by the subject, which must be between 80% and 125% of that observed for the reference drug – and (ii) peak plasma concentration (Cmax).2 All injections are expected to be completed over the next two months. The full results of the bioequivalence study are expected in the autumn. 1 https://clinicaltrials.gov/ct2/show/NCT03103334?term=zeneo&draw=2&rank=5 2 Full study: https://clinicaltrials.gov/ct2/show/NCT05026567?term=zeneo&draw=2&rank=1 2 Contacts: Crossject Patrick Alexandre [email protected] Investor relations CIC Market Solutions Catherine Couanau +33 (0)1 53 48 81 97 [email protected] Press relations Buzz & Compagnie Mélanie Voisard +33 (0)3 80 43 54 89 [email protected] Christelle Distinguin +33 (0)6 09 96 51 70 [email protected] 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 paten ted needle- free 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, and benefits from Bpifrance funding.

The release as fetched from its publisher. crossject.com ↗