ImmuPharma PLC (AIM:IMM, OTC:IMMPF) has announced that its US partner for Lupuzor (P140), Avion Pharmaceuticals has received a written response from the US Food and Drug Administration (FDA) to its Type C meeting regarding the development and review of the product.
The specialist drug discovery and development company said the FDA response was detailed and included significant guidance on next steps for the clinical programme for the potential treatment for the autoimmune disease Lupus, which included advice on the dosing regime.
In addition, the FDA also provided further significant guidance on the study protocol that can be amended to improve the regulatory outcome, it added.
ImmuPharma said it is currently reviewing the written response with Avion and will make a further notification in due course.
Lupuzor, which has already been tested in one phase III trial, was shown in its PK study to be safe and well tolerated across all doses and in all subjects.
The planned international phase III trial requires the presence of a biomarker before being allowed into the study, with the previous phase III study finding that patients who were biomarker positive (anti-ds DNA antibody positive) responded better to Lupuzor than those who were biomarker negative.