Injectable therapy for infantile epileptic disease to enter phase 3 trial
Amzell BV, a specialty pharmaceutical development company, announced it has a special protocol assessment agreement with the FDA for a phase 3 trial of its injectable infantile epileptic disease therapy.
The treatment, AMZ002, is a sterile injectable hormone that would provide a purified synthetic polypeptide as an alternative to current FDA-approved epileptic seizure treatments. According to a press release, the hormone has a purity greater than 95%, which enables high and reproducible product manufacturing quality.
In the phase 3 trial, researchers will utilize a superiority study to compare AMZ002 with another active treatment.
Although rare, with fewer than 200,000 cases in the U.S. each year, infantile epileptic disease is linked to significant unmet need due to a lack of treatment options, according to the release.
“We are delighted to have agreed with the FDA on our AMZ002 phase 3 trial protocol,” Dario N. Carrara, PhD, CEO of Amzell BV, said in the release. “Our purified, synthetic injectable should provide a treatment option for epileptic seizures, suited to best meet the needs of a highly vulnerable patient population, and we look forward to initiating the trial in the coming months.”