Melbourne-based company Neuren Pharmaceuticals (ASX:NEU) says it has initiated the manufacture of NNZ-2591 to supply the planned phase two clinical trials.
The company said the contract manufacturer that supplied drug substance for the ongoing phase one trial will carry out this larger scale manufacturing.
According to Neuren CEO Jon Pilcher, “We have made excellent progress in the optimisation and scale up of the manufacturing process for NNZ-2591. This investment is another important stepping-stone towards the Phase 2 trials in 2021, in which we aim to confirm the potential of NNZ-2591 to address the urgent unmet need in three serious childhood disorders.”
Neuren said it plans to commence phase two trials in 2021 in patients with Phelan-McDermid syndrome, Angelman syndrome and Pitt Hopkins syndrome.
Neuren has received Orphan Drug designation from the FDA for NNZ-2591 to treat all three of these debilitating disorders that currently have no approved medicines.