08 October 2021
1 minute read
Amzell BV, a specialty pharmaceutical development company, announced that it has entered into a special protocol evaluation agreement with the FDA for a Phase 3 trial of its injectable treatment for childhood epilepsy.
The treatment, AMZ002, is a sterile injectable hormone that is believed to provide a purified synthetic polypeptide as an alternative to current FDA-approved seizure treatments. According to a press release, the hormone has a purity of over 95%, which allows for high and reproducible product build quality.
In the Phase 3 trial, researchers will use a superiority study to compare AMZ002 with another active treatment.
Although rare, with fewer than 200,000 cases in the United States each year, childhood epileptic disease is linked to significant unmet need due to a lack of treatment options, the statement said.
“We are delighted to have agreed with the FDA on our phase 3 trial protocol AMZ002”, Dario N. Carrara, Doctorate, CEO of Amzell BV, said in the statement. “Our purified synthetic injectable is expected to provide a treatment option for epileptic seizures tailored to best meet the needs of a highly vulnerable patient population, and we look forward to starting the trial in the coming months. “