ImmuPharma PLC (AIM:IMM, OTC:IMMPF) has confirmed a Type-C meeting is scheduled with the US Food and Drug Administration (FDA) for 7 June.
Scientists will discuss the upcoming phase II/III adaptive study of Lupuzor (also known as P140) in systemic lupus erythematosus patients. This development follows the company's recent announcement on 27 March 2023.
The company's US partner, Avion, has submitted a comprehensive package of documents to the FDA, addressing critical guidance points from the previous interaction with the regulator, particularly concerning dosing.
This guidance complements the clinical pharmacokinetic study completed last year, which offered valuable insights into Lupuzor's dose range and administration method. The latest trial is set to get underway in the second half of 2023.