Amzell, B.V., a specialty pharmaceutical development company based in The Netherlands, and Amring Pharmaceuticals Inc. (Amring), a niche brand and generic pharmaceutical company based in Berwyn, PA, announced today that their lead product in the collaboration, AMZ002, has entered Phase III Clinical Trial in the U.S. for treatment of infantile epileptic disease. AMZ002, a purified synthetic polypeptide, offers an alternative to existing FDA-approved treatment for epileptic seizures. This product received both Rare Pediatric Disease and Orphan-Drug Designations.

This Phase III Clinical Trial is a randomized, open-label superiority study designed to evaluate the efficacy, and safety of AMZ002 in the treatment of infantile spasms (IS). In addition, this trial is one of the first to investigate co-primary endpoints assessing both the absence of spasms and resolution of hypsarrhythmia.

Dario Carrara, PhD, CEO of Amzell noted, “We are very excited that this important treatment has entered the Phase III stage in the U.S. We believe that these AMZ002 studies will provide needed clarity for future treatment strategies for IS, a severe epileptic encephalopathy that leads to neurodevelopmental delay and significant intellectual disability in young children. AMZ002 is the product of decades of hands-on technical and clinical experience with ACTH. ”

“We are pleased that the Phase III program is underway, and that our collaboration with Amzell will produce significant benefits for young children and their parents in the U.S. and globally,” stated Daniel Carbery, President and CEO of Amring. “As the commercialization partner in the collaboration, we are very excited to soon be able to address the need for clinically-validated and cost-effective treatment alternatives for IS.”