PK RESEARCH UPDATE
ImmuPharma will provide an update on the progress of the PK study once it has commenced.Ĭommenting 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. 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. The research groups at USPCAS-E are working on the continuous evolution of research in response to the opportunities generated by new technology and methods. 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. Preparations will be made to commence the Phase 3 study, following completion of the PK study. Dependent on timing of patient recruitment, we anticipate that the PK study will take between 8-12 weeks to complete, from commencement. The study will be carried out in a total of up to 24 healthy male subjects. The PK study is a Phase I study to assess the presence of Lupuzor™ in the body after administration of a single dose.
PK RESEARCH TRIAL
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™. FDA approves the Lupzuor™ PK study 12th August 2021 - 11:44 am
0 kommentar(er)
