ImmuPharma PLC - London-based drug discovery and development company - Gets positive support and guidance from the US Food & Drug Administration after a pre-investigational new drug meeting, which confirms the route for a Phase 2/3 adaptive clinical study of P140 in chronic idiopathic demyelinating polyneuropathy. Says the feedback recognises that P140 is suitable to be studied in another disease indication, in addition to systemic lupus erythematosus.
Says the CIDP market is expected to reach global sales of $2.7 billion by 2029. CIDP is a rare neurological disease with high medical need.
Chief Executive Officer Tim McCarthy says: ‘We are delighted to have received this positive support and guidance from the FDA on our pre-IND application for CIDP. As we now move forward to a full IND application this program remains on track to commence its Phase 2/3 adaptive clinical trial in H2 2023. Furthermore, as our P140 technology platform provides the basis for both our Lupus and CIDP programs, we look forward to also commencing the Lupus Phase 2/3 clinical trial in H2 2023 ’.
Current stock price: 3.39 pence each, up 10% on Thursday around noon in London
12-month change: down 43%
Copyright 2023 Alliance News Ltd. All Rights Reserved.
