ImmuPharma PLC (AIM:IMM, OTC:IMMPF) said preparations are being made to get an international phase III trial of its lupus drug underway after successfully negotiating a key hurdle with the regulator.
Last month’s positive readout from a pharmacokinetic (PK) study of Lupuzor, requested by the US Food & Drug Administration (FDA), has fired the starting pistol on the lead-up work to the pivotal trial.
The clinical evaluation will be overseen by the company’s US partner, Avion Pharmaceuticals.
“Following the positive readout from the PK study, we have been working closely with the team at Avion to move Lupuzor as quickly as possible to the start of the phase III trial," said chief executive Tim McCarthy.
Lupuzor, also known as P140, has multiple potential uses. However, it is currently being developed to treat lupus, a disease where the body’s immune system attacks its own tissue and organs.