FDA confirms Type-C meeting date of 7th June 2023 for Phase 2/3 adaptive study of Lupuzor™ in lupus19th April 2023 - 7:00 am
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is pleased to announce that the Food and Drug Administration (“FDA”) has set a date of 7th June 2023 for a Type-C meeting to provide guidance on the Phase 2/3 adaptive study of Lupuzor™ (“P140”) in patients with systemic lupus erythematosus (“SLE/Lupus”). This follows on from the recent announcement on 27 March 2023.
Avion (our US partner) has provided the FDA with a full package of documents and information which addresses all the key guidance points from the previous Type-C meeting, particularly concerning dosing. The FDA guidance is in addition to the clinical pharmacokinetic (“PK”) study completed last year which provided, amongst other observations, a critical insight into the relevant dose range and method of administration of Lupuzor™ (P140). This Phase 2/3 study remains on track to commence in H2 2023.
Commenting on the announcement, Tim McCarthy, CEO of ImmuPharma, said:
“Following on from our announcement last week of the pre-IND meeting with the FDA on P140 in CIDP, we are delighted to confirm this meeting date with the FDA on P140 in lupus. With the prospect of both of these indications moving positively forward into pivotal studies in H2 2023 there is real value momentum building in our P140 franchise”
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