ImmuPharma (IMM ), a drug discovery and development company, announced positive progress on its late-stage P140 clinical programme in patients with chronic idiopathic demyelinating polyneuropathy (CIDP).
ImmuPharma said it has received confirmation from the US FDA for a pre-Investigational New Drug (pre-IND) meeting date of 16 May 2023, to consider a Phase 2/3 trial study protocol for P140. A new IND submission is required as this will be the first time P140 is studied in humans for the indication of CIDP.
ImmuPharma said it will submit an application for Orphan Drug status following the pre-IND meeting.
Tim McCarthy, CEO of ImmuPharma, commented:
"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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Encouraging news from ImmuPharma regarding its P140 programme for CIDP patients, now greenlit by the FDA for a pre-IND meeting to discuss Phase 2/3 trials. P140's CIDP protocol is founded on existing preclinical and clinical work carried out on P140 (Lupuzor) in Lupus, which itself is scheduled to begin a Phase 2/3 adaptive study in Lupus patients in H2 2023.
Once ImmuPharma receives feedback from the pre-IND meeting, it will file for another meeting date with the FDA for submission of the study protocol, at a Type-B IND meeting.
Should everything go according to plan, ImmuPharma will be conducting clinical studies of P140 in patients with CIDP, a rare neurological disease with a high medical need. The CIDP market is expected to reach global sales of US$2.7bn by 2029.
An application for Orphan Drug status will also 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.
Markets cheered today's news, pushing IMM shares 9.3% higher.
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