Rns dated 18 November 202113 Mar 2025 17:52
In the last three months we have made significant positive progress across the whole P140 platform.
· Lupuzor™: on 12 August 2021, we announced that the US Food & Drug Administration ("FDA") had approved the commencement of the pharmacokinetic ("PK") study as part of the preparation for the new optimised international Phase 3 trial of Lupuzor™. Since then, we have been working with Avion Pharmaceuticals ("Avion"), our exclusive US partner, our specialist Contract Research Organisation ("CRO"), Simbec Orion together with our three service providers, to prepare for commencement of the study. This has progressed well and in preparing the study drug material, we have taken the opportunity to greatly improve the product characterisation and analytical method validations. This has resulted in a new proprietary synthesis of P140 which gives greater IP protection and lowers the cost of production. Final preparations are now being actioned including updating the Investigational Medicinal Product Dossier ("IMPD").
Still banging on about the same stuff 4 years later lol