FDA to agree on the Lupzuor™ PK study via a written response to “Type24th June 2021 - 10:44 am
ImmuPharma PLC (LSE:IMM) (Euronext Growth Brussels: ALIMM), the specialist drug discovery and development company, announces that its US Lupuzor™ partner, Avion Pharmaceuticals (“Avion”) has received a positive response from the US Food & Drug Administration (“FDA”) for a “Type C” meeting. The FDA has advised that they do not require a formal face to face meeting and will provide their written response to Avion approximately by the end of July 2021.
As noted in our previous announcement of 9 February, this is the final guidance meeting at which the FDA will review the proposed methodology of the pharmacokinetic (“PK”) study. This study was requested by the FDA as part of the new optimised international Phase 3 trial of Lupuzor™ in systemic lupus erythematosus (“SLE”), a potentially life-threatening autoimmune disease.
ImmuPharma will provide an update as soon as Avion has received the written response from the FDA and advised ImmuPharma of the next steps and timetable towards commencing the Phase 3 trial this year.
Commenting on the announcement, Tim Franklin, COO of ImmuPharma 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 3 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.”
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