ImmuPharma PLC (AIM:IMM, OTC:IMMPF), a specialist drug discovery and development firm, has announced significant progress with its late-stage clinical programme for treating chronic idiopathic demyelinating polyneuropathy (CIDP).
The US Food and Drug Administration (FDA) has provided positive feedback that supports the application for a phase II/III adaptive clinical trial of P140, the company's key investigative drug.
This FDA guidance underscores the potential of P140 for treating autoimmune conditions beyond systemic lupus erythematosus (SLE).
This is a crucial milestone for P140, marking its first pivotal trial for CIDP, a rare neurological condition.
As the FDA feedback paves the way for an Investigational New Drug (IND) application, ImmuPharma aims to commence the trial by the second half of 2023.
Concurrently, the company will also apply for orphan drug status for CIDP, promising seven years of market exclusivity after approval.
With the CIDP market set to reach a global sales value of US$2.7bn by 2029, ImmuPharma's advancements hold promising potential.
CEO Tim McCarthy said: "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 [second half of the year]."