Business
Positive Pre-IND meeting with FDA
Positive Pre-IND meeting with FDA.
About this update from Immupharma Plc
[{"type":"text","content":"\n\n\n 18 May 2023\n \nImmuPharma PLC\n(\"ImmuPharma\" or the \"Company\")\n \nPositive guidance from the FDA Pre-IND meeting supports an IND application and a Phase 2/3 adaptive clinical trial of P140 in CIDP\n \nImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is pleased to announce further positive progress in its late-stage clinical program in patients with chronic idiopathic demyelinating polyneuropathy (\"CIDP\"), which is a further debilitating auto-immune condition within the Company's P140 platform\n \nKey highlights:\n· ImmuPharma has received positive support and guidance from the Food and Drug Administration (\"FDA\"), following the Pre-Investigational New Drug (\"PIND\") meeting that confirms the route for a Phase 2/3 adaptive clinical study of P140 in CIDP\n· The FDA feedback recognises that P140 is suitable to be studied in another disease indication in addition to SLE (systemic lupus erythematosus) and this strongly supports the underlying science and mechanism of action of P140 across several auto-immune/inflammatory diseases and is a significant breakthrough for the P140 platform\n· The Phase 2/3 adaptive clinical trial will be the first pivotal stage study of P140 in patients with CIDP: a rare ...