CROSSJECT advances on the development of ZEPIZURE® Junior, its solution for epilepsy crises in children

11 Jun 2025 07:30 CEST

Press release

CROSSJECT advances on the development of ZEPIZURE® Junior, its solution for epilepsy crises in children

• Announces the effective calibration of ZENEO^® for the use of ZEPIZURE^® in the pediatric population.
• CROSSJECT completed an echography clinical study allowing to determine and validate the targeted depth of injection in children as compared to adults.

Dijon, France 11 June 2025 (07h30 CET) -- CROSSJECT (ISIN: FR0011716265; Euronext: ALCJ), the specialty pharma company in advanced phases of development and registration for ZEPIZURE® in adults, is progressing in the development of its pediatric version of ZEPIZURE®, branded ZEPIZURE® Junior.

According to the 2022 National Survey of Children’s Health and as reported by the U.S. Centers for Disease Control and Prevention (CDC) on its “Epilepsy Facts & Stats” pages, there are approximately 456,000 children with active epilepsy in the U.S. The active epilepsy population is defined as patients who are diagnosed and actively managed by a caregiver.

Under its contract with the Biomedical Advanced Research and Development Authority (BARDA), CROSSJECT completed a clinical echography study in a 90 adults and children (2-18 years old) to measure and compare the anatomical characteristics of thighs, i.e. the thickness of layers from skin to muscle (CJTCDZ2301, NCT06279689). In parallel CROSSJECT conducted studies on its ex-vivo experimental models that reconstitute the skin and the subcutaneous and muscle layers in children. These tests have successfully enabled the calibration of the pressure to be exerted by the ZENEO® device gas generators to expel the drug solution with the suitable penetration depth and confirmed the adequacy of the ZENEO® device in its “Junior” mode.

Previous Human Factors studies had also included a significant number of children above 8 years of age and did successfully demonstrate their ability to use the autoinjector ZENEO® effectively.

« We are excited by this incremental innovation and the success in our product development. Pediatrics is strategic to CROSSJECT as we want to establish ZEPIZURE® as the standard of care early in this chronic condition. We look forward to advancing with the Food and Drug Administration (FDA) and having concrete clinical solutions to propose to the pediatric patient community », said Patrick ALEXANDRE, CEO of CROSSJECT.

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 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 drugs via intramuscular injection on bare skin or even through clothing. The Company’s other products in developmentmainly include solutions for allergic shocks and adrenal insufficiencies, as well as therapies and other emergency indications.

* This project has been supported in whole or in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A50122C00031.

***

For further information, please contact:

Investor Relations
investors@crossject.com

Attachment

• CROSSJECT advances on the development of ZEPIZURE® Junior