ImmuPharma progresses P140 clinical programme with FDA
By Josh White
Date: Wednesday 12 Apr 2023
(Sharecast News) - Drug discovery and development company ImmuPharma announced positive progress in its late-stage P140 clinical programme on Tuesday, for patients with chronic idiopathic demyelinating polyneuropathy (CIDP), a rare neurological disease with high medical need.
The AIM-traded firm said it had received confirmation from the US Food and Drug Administration (FDA) for a pre-investigational new drug (IND) meeting date of 16 May to consider a phase two and three adaptive trial study protocol for P140 in CIDP.
It said it would be the first pivotal stage clinical study of P140 in patients with CIDP.
A new IND submission was required, as it would be the first time that P140 was being studied in humans for the indication of CIDP.
After the pre-IND meeting, an application for orphan drug status would be submitted.
ImmuPharma said the CIDP market was expected to reach global sales of $2.7bn by 2029.
"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," said chief executive officer Tim McCarthy.
"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."
At 1344 BST, shares in ImmuPharma were up 9.3% at 2.35p.
Reporting by Josh White for Sharecast.com.
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