ImmuPharma PLC (LON:IMM, Euronext Growth Brussels:ALIMM) said its US partner received a positive response from the American drug regulator ahead of a pharmacokinetic (PK) assessment of its lupus treatment.
Avion Pharmaceuticals was granted what’s called a Type C meeting with the Food & Drug Administration which will allow the watchdog to “review the proposed methodology” of the PK study.
It was requested as part of the new optimised international phase III trial of Lupuzor, the ImmuPharma-developed treatment for systemic lupus erythematosus, a potentially life-threatening autoimmune disease.
A response from the FDA is expected around the end of next month.
Tim Franklin, ImmuPharma’s chief operating officer, said: "We continue to acknowledge the FDA's support following constructive meetings and feedback this year with our partner Avion.
“ImmuPharma and Avion are fully committed to commencing the Lupuzor phase III trial in Lupus patients this year.
“Again, we reiterate Lupuzor's unique mechanism of action and robust safety profile to date, which we believe will position Lupuzor as a first-line therapy to many Lupus sufferers globally."