Avion seeks final regulatory guidance as it prepares for the start of the international Phase 3 trial of Lupuzor™ in Lupus patients27th June 2022 - 10:40 am
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is delighted to announce that, having met all the Food and Drug Administration’s (“FDA”) requirements, Avion Pharmaceuticals (“Avion”), its US partner, has confirmed that it has sought final regulatory guidance from the FDA, as it actively prepares for the start of the international Phase 3 trial of Lupuzor™ in Lupus patients.
This confirmation follows a recent meeting between the two companies at Avion’s US headquarters in Atlanta, Georgia.
Further to our last update on 4th May 2022, Avion has submitted, via a Type C Meeting, the positive results from the Lupuzor™/P140 Pharmacokinetic (“PK”) study to the FDA.
As noted in previous announcements, the PK study required by the FDA, met all the key endpoints and (in line with all human dosing to date), demonstrated that P140 was safe and well tolerated across all doses and in all subjects.
As previously disclosed, as an integral part of the licence and development agreement for Lupuzor™ entered into between Avion and ImmuPharma, the new international Phase 3 trial for Lupuzor™ is being funded by Avion, who have the exclusive rights to commercialise Lupuzor™ in the US, whilst the rest of the world rights remain with ImmuPharma.
Commenting on the announcement, Tim McCarthy, Chief Executive Officer, said: “This final step by Avion is a pivotal moment for the Company and for the progress of Lupuzor™ towards becoming a groundbreaking new treatment for Lupus patients. Lupuzor’s™ unique mechanism of action and robust safety profile will, we believe, position Lupuzor™ as a first line therapy to many Lupus sufferers globally.”
Art Deas, Chief Executive Officer of Avion further commented: “Having met all the FDA’s requirements, we are delighted to be seeking the FDA’s final guidance on moving Lupuzor™ forward into the new international Phase 3 trial. We anticipate Lupuzor™ becoming the leading product in our portfolio and that it will be instrumental in bringing an innovative treatment to Lupus patients, which is not currently available on the market today.”
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