ImmuPharma PLC (LON:IMM; Euronext Growth Brussels:ALIMM) said the international phase III trial of its lupus drug Lupuzor remains on track to begin in the second half.
The update followed guidance proffered by the US regulator after its interaction in December with Avion Pharmaceuticals, which is leading the development of the drug.
After the Type-A meeting with the US Food & Drug Administration (FDA) plans have been made to develop and validate a bioanalytical assay and to confirm the clinical pharmacology and pharmacokinetic characterizations of Lupuzor before starting the study.
A final guidance meeting has been set up with the FDA for next quarter at which Avion will submit the method for assessing the pharmacokinetics of the drug as part of the trial.
Avion has been told that a Special Protocol Assessment “will not be applicable” and conditional approval “has not been confirmed at this time”.
ImmuPharma chief executive, Dimitri Dimitriou, said: "We are extremely pleased to see the positive progress of Lupuzor towards the commencement of the international phase III trial with Avion.
“We will continue to work closely with Avion over the next period to ensure the start of the phase 3 study remains on schedule for the second half of 2021."