ImmuPharma PLC (AIM:IMM, OTC:IMMPF) said its partner in developing Lupuzor, a potential treatment for the autoimmune disease Lupus, has received quick confirmation from the US drug regulator for a 'Type C' meeting by the end of next month.
Avion Pharmaceuticals sought the meeting to obtain final guidance on its imminent phase III trial of Lupuzor.
There will be no requirement for a face-to-face meeting, however, with Avion Pharmaceuticals and the US Food and Drug Administration (FDA) having agreed to the purpose, objectives and proposed agenda of the meeting, as well as agreeing that written responses will suffice.
The agreed date from the FDA for providing its written responses is 29 August 2022.
Tim McCarthy, ImmuPharma's chief executive officer, said: "We applaud the quick turnaround from the FDA in respect to Avion's request for this Type C Meeting and are pleased to note the FDA's confirmation that only a written response is required and no face to face meeting is needed.”
As well as presenting data from a pharmacokinetic (PK) study requested by the FDA, Avion was said to have also asked questions related to the use of the drug, which “aims to strengthen the future product label and secure advantageous differentiation” of the treatment for use in Lupus patients.
Lupuzor, which has already been tested in one phase III trial, was shown in the PK study to be safe and well tolerated across all doses and in all subjects.
The planned international phase III trial requires the presence of a biomarker before being allowed into the study, with the previous phase III study finding that patients who were biomarker positive (anti-ds DNA antibody positive) responded better to Lupuzor than those who were biomarker negative.