Positive guidance from the FDA Pre-IND meeting supports an IND application and a Phase 2/3 adaptive clinical trial of P140 in CIDP18th May 2023 - 9:00 am
ImmuPharma 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
- 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
- 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
- The Phase 2/3 adaptive clinical trial will be the first pivotal stage study of P140 in patients with CIDP: a rare neurological disease with high medical need
- An IND application will now be prepared for submission to the FDA, incorporating all guidance points and pending approval, we remain on track to commence* the Phase 2/3 adaptive clinical trial in H2 2023
- An application for Orphan Drug status for CIDP will be also submitted in parallel to the full IND application
- The CIDP market is expected to reach global sales of US$2.7bn by 2029
This feedback from the FDA provides not only positive support and guidance for an IND application and acceptance of the Phase 2/3 clinical trial design for CIDP, but also recognises the potential therapeutic benefit in another auto-immune/inflammatory disease in addition to P140 (Lupuzor™) in SLE, representing a significant breakthrough for the P140 platform.
The Phase 2/3 clinical trial will be the first pivotal stage study of P140 in patients with CIDP: a rare neurological disease with high medical need. The study design was developed with our contract research organisation (CRO) and CIDP opinion leaders from Europe and the USA.
The CIDP protocol is founded on much of the preclinical and clinical work carried out to date on P140 (Lupuzor™) in SLE, which itself is scheduled to begin a Phase 2/3 adaptive clinical trial in Lupus patients in H2 2023. Many elements of the FDA guidance for CIDP, particularly the Phase 2/3 protocol design and dosing, can now be anticipated for the upcoming FDA Type-C meeting for P140 (Lupuzor™) in SLE on or around the 7th June 2023.
An application for Orphan Drug status will be submitted, in parallel to the IND application Acceptance for Orphan Drug status this year will provide 7 years’ market exclusivity post-marketing approval.
The CIDP market is expected to reach global sales of US$2.7bn by 2029.
*Commencement is defined as the CRO is chosen, trial sites are being confirmed and set-up and regulatory and ethics committee submissions are progressing.
Commenting on the announcement, Tim McCarthy, CEO of ImmuPharma, said:
“ 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 ”.
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