Business
LupuzorT Update
LupuzorT Update.
About this update from Immupharma Plc
[{"type":"text","content":"\n \n \n \n \n \n \n \n \n \n \n 27 March 2023\n \n \n \n \n \n \n \n \n \n ImmuPharma PLC\n \n \n \n (\"ImmuPharma\" or the \"Company\")\n \n \n \n \n \n \n Avion submits clinical protocol of Phase 2/3 adaptive study of Lupuzor™ in lupus to FDA\n \n \n \n \n \n \n ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is delighted to update the market on the next positive step in its Lupuzor™ (P140) program in patients with systemic lupus erythematosus (\"SLE/Lupus\"). This follows on from the recent announcement on 6 February 2023.\n \n \n \n \n \n \n \n \n Key highlights:\n \n \n \n \n \n \n ·\n Avion Pharmaceuticals (\"Avion\") and ImmuPharma agreed in February on a Phase 2/3 adaptive trial design for the next clinical study of Lupuzor™ in Lupus patients.\n \n \n ·\n A Phase 2/3 clinical trial protocol has now been submitted to the Food and Drug Administration (\"FDA\"). This new design takes into account the FDA's key guidance points from the previous Type-C meeting in addition to insights from the pharmacokinetic (\"PK\") study completed last year.\n \n \n ·\n The submitted protocol contains many changes from the design of the previous Phase 3 clinical trial carried out by ImmuPharma. The most significant and important changes concern the level of dose being administered and the method of administration.\n \n \n ·\n A Type C meeting with the FDA has been requested and the date of the meeting should be confirmed within the FDA guidelines of 21 days from submission which is expected to be within the FDA guidelines of 75 days from submission. We will update the market with the date of the meeting once confirmed by FDA.\n \n \n ·\n The Phase 2/3 study remains on track to commence in H2 2023.\n \n \n \n \n \n On 6 February 2023, ImmuPharma confirmed that they had agreed with Avion on an adaptive Phase 2/3 study for Lupuzor™ in SLE patients. For background, this is a one-protocol pivotal study which allows exploration of a dose-range in the Phase 2 part of the study, followed by seamless progression into the Phase 3 part of the study at the chosen dose. The overall timelines are much shorter than carrying out two separate protocols (i.e. Phase 2 followed by Phase 3). It is also expected to be less costly overall.\n \n \n \n \n \n This new study design inc...