Research & Development
ImmuPharma reports Avion seeking final FDA guidance ahead of Phase 3 trial of Lupuzor
27 June 2022 -

Drug discovery and development company ImmuPharma plc (LSE:IMM) said on Monday that its US partner, Avion Pharmaceuticals, is seeking final regulatory guidance from the US Food and Drug Administration (FDA) as it prepares for the start of the international Phase 3 trial of Lupuzor, a first-in class autophagy immunomodulator, in lupus patients.

Lupus (Systemic Lupus Erythematosus or SLE) is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs.

Avion has submitted positive results from the Lupuzor/P140 pharmacokinetic study to the FDA. This study met all the key endpoints and (in line with all human dosing to date) demonstrated that the treatment was safe and well tolerated across all doses and in all subjects.

As part of the licence and development agreement for Lupuzor entered into between Avion and ImmuPharma, the new international Phase 3 trial is being funded by Avion, which has the exclusive rights to commercialise Lupuzor in the US. The rest of the world rights remain with ImmuPharma.