AMZELL to initiate FDA-approved Phase 3 trial of innovative injectable treatment for infantile epileptic disease

<p style="margin-bottom:0cm;margin-bottom:.0001pt;line-height:150%;"><img src="" alt="" />Specialist development pharmaceutical company AMZELL B.V has concluded discussions with the FDA ahead of initiating a Phase 3 trial of its new treatment for infantile epileptic disease, AMZ002. </p><p style="margin-bottom:0cm;margin-bottom:.0001pt;line-height:150%;">&nbsp;</p><p style="margin-bottom:0cm;margin-bottom:.0001pt;line-height:150%;">The Phase 3 trial will compare AMZ002 to another active treatment in a superiority study, as a placebo-controlled trial would not be ethical for this patient population. AMZ002 is a sterile injectable hormone and would offer a purified synthetic alternative to an existing FDA-approved treatment for epileptic seizures. </p><p style="margin-bottom:0cm;margin-bottom:.0001pt;line-height:150%;">&nbsp;</p><p style="margin-bottom:0cm;margin-bottom:.0001pt;line-height:150%;">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 of age, and over 90% of cases begin before 12 months of age.<span>&nbsp; </span>Infantile epileptic disease is an orphan indication, affecting fewer than 200,000 patients in the United States. The lack of treatment options for the condition means that there is a considerable unmet need. </p><p style="margin-bottom:0cm;margin-bottom:.0001pt;line-height:150%;">&nbsp;</p><p style="margin-bottom:0cm;margin-bottom:.0001pt;line-height:150%;">Dario N. Carrara PhD, Chief Scientific Officer commented: &ldquo;We are delighted to have had such positive feedback from the FDA on our proposed Phase 3 trial of AMZ002, and hope to initiate the trial in the coming months. Our purified, synthetic injectable should provide a treatment option for epileptic seizures, suited to best meet the needs of this highly vulnerable patient population.&rdquo;</p><p style="margin-bottom:0cm;margin-bottom:.0001pt;line-height:150%;">&nbsp;</p><p style="margin-bottom:0cm;margin-bottom:.0001pt;line-height:150%;">Following the Type B End of Phase 2 meeting with the FDA Division of Neurology for AMZ002, AMZELL has agreed the general study design, dosing, primary and secondary endpoints and the estimative sample size for the Phase 3 trial, and has now submitted the protocol utilizing a Special Protocol Agreement. </p><p style="margin-bottom:0cm;margin-bottom:.0001pt;line-height:150%;">&nbsp;</p><p style="margin-bottom:0cm;margin-bottom:.0001pt;line-height:150%;">Further details on this Phase 3 trial will be confirmed following the FDA&rsquo;s approval of AMZELL&rsquo;s proposed protocol. </p><p style="margin-bottom:0cm;margin-bottom:.0001pt;line-height:150%;">&nbsp;</p><p style="margin-bottom:0cm;margin-bottom:.0001pt;line-height:150%;">AMZ002 is the latest product to reach Phase 3 from AMZELL, which specialises in developing well-characterized active substances through to proof-of-concept or registration for sale to commercial partners. AMZELL&rsquo;s innovative platform drug delivery technologies provide effective drug delivery, increased efficacy, and improved safety and compliance.</p><p style="margin-bottom:0cm;margin-bottom:.0001pt;line-height:150%;">&nbsp;</p><p style="margin-bottom:0cm;margin-bottom:.0001pt;line-height:150%;"><strong><span style="text-decoration:underline;"></span></strong></p><p style="margin-bottom:0cm;margin-bottom:.0001pt;line-height:150%;"><strong><span style="text-decoration:underline;">About AMZELL </span></strong></p><p style="margin-bottom:0cm;margin-bottom:.0001pt;line-height:150%;">AMZELL B.V is a specialist, virtual development pharmaceutical company which takes candidate or repurposed drugs and devices either through to proof of concept, or through to registration for sale to commercial healthcare companies.</p><p style="margin-bottom:0cm;margin-bottom:.0001pt;line-height:150%;">&nbsp;</p><p style="margin-bottom:0cm;margin-bottom:.0001pt;line-height:150%;">AMZELL B.V has particular interest in developing well-characterized active substances utilizing innovative platform drug delivery technologies, with the aim to provide more effective drug delivery, increased efficacy, and improved safety and compliance.</p><p align="center" style="margin-bottom:0cm;margin-bottom:.0001pt;text-align:center;line-height:150%;">&nbsp;</p>