ImmuPharma PLC (AIM:IMM, OTC:IMMPF) said its US partner has sought final regulatory guidance from the Food & Drug Administration (FDA) as it "actively prepares" for the start of the international phase III trial of Lupuzor, a potential treatment for the autoimmune disease lupus.
"This final step by Avion is a pivotal moment for the company and for the progress of Lupuzor towards becoming a ground-breaking new treatment for Lupus patients,” said ImmuPharma chief executive, Tim McCarthy.
“Lupuzor's unique mechanism of action and robust safety profile will, we believe, position Lupuzor as a first-line therapy to many Lupus sufferers globally."
Avion Pharmaceuticals has a licence and development agreement in the States for Lupuzor, also known as P140. This means the phase III evaluation will be funded by the American group.
ImmuPharma has retained the international rights to the drug.