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(Sharecast News) - Specialist drug discovery and development company ImmuPharma said on Wednesday that final preparations were now underway to progress 'Lupuzor' into its new, optimised international phase 3 trial in lupus patients.
The AIM-traded firm said that, further to the recent positive results from the pharmacokinetic study announced in April, its US partner Avion Pharmaceuticals was now requesting final guidance from the US Food and Drug Administration (FDA) to start the phase 3 trial.
It said the pharmacokinetic study, required by the FDA, demonstrated that the key endpoints had been met, and that P140 was safe and well tolerated across all doses and in all subjects in-line with all human dosing to date.
"We are delighted to be announcing positive progress towards the commencement of the new optimised international phase 3 trial of Lupuzor in lupus patients," said chief executive officer Tim McCarthy.
"Following the positive readout from the pharmacokinetic study, we have been working closely with the team at Avion to move Lupuzor as quickly as possible to the start of the phase 3 trial."
At 1221 BST, shares in ImmuPharma were up 4.04% at 6.7p.
