ImmuPharma says US partner makes regulatory and operational progress ahead of phase III trial of lup
ImmuPharma PLC (LON:IMM) said its licensing partner has made headway with the regulatory authorities in the US ahead of a new optimised phase III study of the former’s lupus treatment.
It said the Food & Drug Administration has agreed to accept a submission made by Avion Pharmaceuticals supporting a request for a Type-A meeting that would provide clinical guidance for a phase III trial of the ImmuPharma-developed drug Lupuzor.
The information for the Type A meeting was forwarded to the FDA on November 6, and, normally, a meeting would take place within 30 days. However, this cannot be guaranteed, ImmuPharma said.
In the same announcement, the company said Avion had asked the FDA to consider the conditional approval of Lupuzor ahead of the completion of the final-stage clinical study.
This would be based on the “clinically significant data” generated from completed phase II and III trials. These showed the treatment was extremely safe and well-tolerated.
Finally, ImmuPharma said production of a new batch of Lupuzor had begun specifically for the phase III trial.