22 November 2021 - - Netherlands-based pharmaceutical development company Amzell, B.V. and US-based niche brand and generic pharmaceutical company Amring Pharmaceuticals Inc say the lead product in their collaboration, AMZ002, has entered Phase III Clinical Trial in the US 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.

In addition, this trial is one of the first to investigate co-primary endpoints assessing both the absence of spasms and resolution of hypsarrhythmia.

Amring Pharmaceuticals is a privately held pharmaceutical company that provides niche generics and value-driven brands to the market.

Amring is partnered with well-established global biopharmaceutical companies and is uniquely positioned to leverage its expertise in bringing biotechnology derived medicines, sterile manufacturing and other state of the art technologies to the marketplace.

Amzell B.V. is a specialist development pharmaceutical company which takes candidate drugs and devices either through to proof of efficacy or through to marketing authorization for further commercialization in partnership with leading niche-based commercial healthcare companies.

The company, based in Hoofddorp, The Netherlands, was founded in 2016.

Amzell has particular interest in developing well-characterized, active pharmaceutical ingredients using innovation platform drug delivery technologies to provide more effective drug delivery, increased efficacy, and improved safety and compliance.