FDA approves the Lupzuor™ PK study12th August 2021 - 11:44 am
ImmuPharma PLC (LSE:IMM) (Euronext Growth Brussels: ALIMM), the specialist drug discovery and development company, is delighted to announce that the US Food & Drug Administration (“FDA”) has approved the commencement of the pharmacokinetic (“PK”) study, as part of the new optimised international Phase 3 trial of Lupuzor™.
The PK study is a Phase I study to assess the presence of Lupuzor™ in the body after administration of a single dose. The study will be carried out in a total of up to 24 healthy male subjects. Dependent on timing of patient recruitment, we anticipate that the PK study will take between 8-12 weeks to complete, from commencement.
Preparations will be made to commence the Phase 3 study, following completion of the PK study. For the continued late-stage program development, ImmuPharma and Avion Pharmaceuticals LLC (“Avion”), as part of a joint steering committee, agreed on a collaborative group consisting of a Board of Key Opinion Leaders (“KOLs”) and a leading medical patient advocacy group. Collectively, this network, due to its in-depth knowledge of the lupus disease and their access to lupus patient groups, will be invaluable to the successful outcome of the Phase 3 trial.
ImmuPharma will provide an update on the progress of the PK study once it has commenced.
Commenting on the announcement, Tim McCarthy, Chairman & CEO of ImmuPharma 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 3 study, on the successful completion of the PK study.”
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