Specialist development drug company Amzell B.V has concluded discussions with the FDA before initiating a phase 3 trial of its new treatment for infantile epileptic disease, AMZ002.
The phase 3 trial will compare AMZ002 to a different active treatment during a superiority study, as a placebo-controlled trial wouldn’t be ethical for this patient population. AMZ002 may be a sterile injectable hormone and would offer a purified synthetic alternative to an existing FDA-approved treatment for epileptic seizures.
Infantile epileptic disease can cause global neurodevelopmental delay, significant intellectual disability, and currently has limited treatment options and a poor prognosis. In most cases, the initial age of onset is between 3 and 12 months aged , and over 90% of cases begin before 12 months aged . Infantile epileptic disease is an orphan indication, affecting fewer than 200,000 patients within the us . the shortage of treatment options for the condition means there’s a substantial unmet need.
Dario N. Carrara PhD, chief scientific officer commented: “We are delighted to possess had such regeneration from the FDA on our proposed phase 3 trial of AMZ002, and hope to initiate the trial within the coming months. Our purified, synthetic injectable should provide a treatment option for epileptic seizures, suited to best meet the requirements of this highly vulnerable patient population.”
Following the sort B End of phase 2 meeting with the FDA Division of Neurology for AMZ002, Amzell has agreed the overall study design, dosing, primary and secondary endpoints and therefore the estimative sample size for the phase 3 trial, and has now submitted the protocol utilizing a Special Protocol Agreement.
Further details on this phase 3 trial are going to be confirmed following the FDA’s approval of Amzell’s proposed protocol.
AMZ002 is that the latest product to succeed in phase 3 from Amzell, which specialises in developing well-characterized active substances through to proof-of-concept or registration purchasable to commercial partners. Amzell’s innovative platform drug delivery technologies provide effective drug delivery, increased efficacy, and improved safety and compliance.
Amzell B.V may be a specialist, virtual development drug company which takes candidate or repurposed drugs and devices either through to proof of concept, or through to registration purchasable to commercial healthcare companies.