UPDATE on LUPUZOR™ – POSITIVE PROGRESS to PHASE 3 with AVION4th May 2022 - 10:53 am
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is delighted to confirm that final preparations are now underway to progress Lupuzor™ into its new optimised international Phase 3 trial of Lupuzor™ in lupus patients.
Further to the recent positive results from the Lupuzor™/P140 Pharmacokinetic (“PK”) study announced on 13 April 2022, we are pleased to announce that Avion Pharmaceuticals (“Avion”), our US partner, has confirmed to us, that they are now requesting final guidance from the US Food & Drug Administration (“FDA”), in order to commence the Lupuzor™ Phase 3 trial.
As we reported, the PK study required by the FDA, demonstrated that the key endpoints had been met and in-line with all human dosing to date, that P140 was safe and well tolerated across all doses and in all subjects.
Commenting on the announcement, Tim McCarthy, Chief Executive Officer, said:“We are delighted to be announcing positive progress towards the commencement of the new optimised international Phase 3 trial of Lupuzor™ in lupus patients. Following the positive readout from the PK study, we have been working closely with the team at Avion to move Lupuzor™ as quickly as possible to the start of the Phase 3 trial.”
Download this announcement