The Food & Drug Administration has given ImmuPharma PLC's (AIM:IMM) (Euronext Growth Brussels: ALIMM) partner the green light to carry out a pharmacokinetic (PK) study on the lupus treatment, Lupuzor.
The evaluation, which will take eight-to-12 weeks to complete, will assess the presence of the drug in the body after a single dose of the drug.
A total of 24 male subjects will be recruited to take part in the additional data-gathering exercise.
Preparations will be made for a new optimised international phase III trial of the treatment once the pharmacokinetic study is complete.
Chairman Tim McCarthy said: "We are extremely pleased to see the next positive steps for Lupuzor, with continued positive dialogue with the FDA, their approval to commence the PK study and an agreed clinical and regulatory pathway over the next period.
“We look forward to providing further progress updates on the PK study and ultimately moving Lupuzor™ forward into the optimised phase III study, on the successful completion of the PK study."