ImmuPharma PLC (AIM:IMM, OTC:IMMPF) said the US Food and Drug Administration (FDA) has called a pre-investigational new drug (IND) meeting for 16 May 2023 to discuss a phase II/II adaptive trial study protocol for lead asset P140.
The regulator will consider a new use for the treatment: namely, chronic idiopathic demyelinating polyneuropathy (CIDP), a rare neurological disease with high medical need.
The study design was developed in collaboration with a contract research organisation and CIDP opinion leaders from Europe and the US.
Following the pre-IND guidance meeting, ImmuPharma will request a meeting date with the FDA for the submission of the study protocol at what's called a Type-B IND meeting.
It also plans to submit an application for orphan drug status. If approved, the company will receive seven years of market exclusivity post-marketing approval. The CIDP market is projected to reach global sales of US$2.7 billion by 2029, according to Data Bridge Market Research.
Tim McCarthy, ImmuPharma's chief executive, 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."
Also known as Lupuzor, the drug is also being developed to treat the autoimmune disease, lupus.