(ASX:NEU) has announced that manufacturing of the drug substance for phase two trials of NNZ-2591 has been successfully completed on schedule.
The company said it is preparing to submit Investigational New Drug (IND) applications to the US FDA for trials in children with Phelan-McDermid syndrome, Angelman syndrome and Pitt Hopkins syndrome.
CEO Jon Pilcher said, “We have successfully developed a proprietary process for large scale manufacturing with exceptional purity and high yield.
“This is a key part of the strong foundations we have built for NNZ-2591, which can now be leveraged across multiple valuable indications.
“As well as supplying the upcoming trials in Phelan-McDermid, Angelman and Pitt Hopkins, the campaign has produced enough drug substance at no extra cost to supply a Phase 2 trial in Prader-Willi syndrome.”
The company said this announcement means it has met four of the milestones for 2021 it recently set out in an updated corporate presentation.
“Five important milestones remain, leading up to the Rett syndrome Phase 3 trial topline results expected in Q4 2021,” it said.