ImmuPharma receives confirmation of pre-IND meeting date with FDA for a Phase 2/3 adaptive study of P140 in CIDP12th April 2023 - 11:41 am
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is pleased to announce further positive progress in its late-stage P140 clinical program in patients with chronic idiopathic demyelinating polyneuropathy (“CIDP”).
- ImmuPharma has received confirmation from the Food and Drug Administration (“FDA”) for a pre- Investigational New Drug meeting date of 16 May 2023 to consider a Phase 2/3 adaptive trial study protocol for P140 in CIDP
- This will be the first pivotal stage clinical study of P140 in patients with CIDP: a rare neurological disease with high medical need
- A new Investigational New Drug (“IND”) submission is required, as this will be the first time that P140 is to be studied in humans for the indication of CIDP
- An application for Orphan Drug status will be submitted following the pre-IND meeting
- The CIDP market is expected to reach global sales of US$2.7bn by 2029*
In a significant new positive step forward in its P140 platform, ImmuPharma has received confirmation from the FDA of a meeting date of 16 May 2023 for a pre-IND meeting to consider a Phase 2/3 adaptive trial study protocol for CIDP.
This will be the first pivotal stage clinical 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.
A new IND submission is required for CIDP, as this will be the first time that P140 is to be studied in humans for the indication of CIDP. Once ImmuPharma has received the feedback from this pre-IND guidance meeting, a request will be made to FDA for a meeting date for submission of the study protocol, at a Type-B IND meeting.
An application for Orphan Drug status will be submitted following the pre-IND meeting. If approved, this will provide 7 years’ market exclusivity post-marketing approval. Acceptance for Orphan Drug status is expected in H2 2023. The CIDP protocol is founded on much of the preclinical and clinical work carried out to date on P140 (Lupuzor™) in Lupus, which itself is scheduled to begin a Phase 2/3 adaptive study in Lupus patients in H2 2023.
* Source: Data Bridge Market Research, Dec 2022
Commenting on the announcement, Tim McCarthy, CEO of ImmuPharma, said:
“We are delighted to be moving P140 into its second indication for CIDP patients who suffer from a rare disease with high unmet medical need. This is a great example of P140’s broad potential. Like many autoimmune and inflammatory conditions such as lupus, CIDP is caused by a similar biological mechanism. P140’s unique mechanism of action selectively corrects these, making it a promising treatment option across a range of indications”.
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