Crossject, the creator of Zeneo, a needle free injection system, announces the similarity between the Zeneo Methotrexate needle-free injection system and the current injectable formulation. Zeneo Methotrexate has met its objectives in a key bioequivalence study, enabling Crossject to show the clinical effectiveness of its innovating product, also called "needle free injection".
This clinical study, also called a bioequivalence study, is the only one needed to confirm the effectiveness and the safety of the product, with a view to complete the filing of the marketing authorisation (MA) application for Zeneo Methotrexate in Europe. Moreover, Crossject's clinical development plan for Zeneo Methotrexate has received approval from the ANSM and the FDA.
Zeneo Methotrexate, an innovative needle-free and subcutaneous auto-injection device, has been developed principally for the treatment of rheumatoid polyarthritis, a chronic inflammatory disease which can lead to deformities and deterioration of joints. Methotrexate is already registered in the form of pre-filled syringes.
The single center bioequivalence study was conducted on 52 subjects. The results demonstrate the similarity between Zeneo needle-free administration and current needle injection systems, as the principal objectives of the study were achieved. Zeneo delivered the desired dose of methotrexate (25 mg).
The success of this study has allowed Crossject to confirm Zeneo's potential to offer better treatment compliance compared to current injection systems. It also promises to be better tolerated when compared to oral formulations of methotrexate.
Zeneo Methotrexate already has a commercialisation partner in France. These results should help accelerate current negotiations with potential European and international commercialisation partners for this promising product.
Patrick Alexandre, President and founder of Crossject, stated: "We are very pleased with the positive results of this study, which confirm the effectiveness and reliability of our Zeneo device. These results represent an important landmark in the development of our needle-free Zeneo device and make us more optimistic about our ability to successfully execute our strategy and build value from our portfolio of exciting supergeneric products."