ImmuPharma PLC (LON:IMM) (Euronext Growth Brussels:ALIMM) has said that its partner Avion Pharmaceuticals will discuss with US regulators early next month plans for an optimised phase III study of a lupus drug developed by the UK company.
At the Type ‘A’ Meeting, to be held on December 4, the firm said Avion will ask for guidance from the US Food & Drug Administration (FDA) on key aspects of the study design, clinical endpoints and the approval process for treatment, called Lupuzor.
It will also request the FDA consider conditional approval of the drug, whilst the final-stage trial is taking place.
In a statement, ImmuPharma chief executive Dimitri Dimitriou said: "ImmuPharma and Avion are delighted that the FDA are expediting the Type 'A' Meeting for early December 2020.
“We look forward to providing a further update to the market following confirmation from Avion of the FDA's guidance post this meeting."