9th Feb 2021 10:36
(Alliance News) - ImmuPharma PLC on Tuesday said it has received feedback from the US Food & Drug Administration via Avion Pharmaceuticals, its licensing partner for auto-immune disease Lupus treatment Lupuzor, regarding plans for its phase three trial.
The London-based pharmaceutical development company said in November that Avion was due to meet with the FDA on December 4 to discuss the phase three trial of Lupuzor and to ask for guidance on key aspects of the study design, clinical end points and approval process. It also asked the FDA to consider the conditional approval of Lupuzor while the phase three trial is underway.
Shares in ImmuPharma were down 14% at 10.15 pence in London on Tuesday.
In response to the feedback, ImmuPharma and Avion said they have plans to develop and validate a bioanalytical assay to confirm the clinical pharmacology and pharmacokinetic characterisations of Lupuzor, before the phase three trial begins.
Further FDA feedback specified that a special protocol assessment will not be applicable, and conditional approval of Lupuzor while the phase three trial is underway has not been confirmed at this time.
ImmuPharma said Avion is planning a final guidance meeting with the FDA in the second quarter of 2021 to submit the methodology for assessing pharmacokinetic characterisations as part of the phase three trial. The meeting will also confirm previous submissions to FDA on the study design, clinical end points and approval process, it added.
"We are extremely pleased to see the positive progress of Lupuzor towards the commencement of the international phase three trial with Avion. We will continue to work closely with Avion over the next period to ensure the start of the phase three study remains on schedule for the second half of 2021," said ImmuPharma Chief Executive Dimitri Dimitriou.
By Zoe Wickens; [email protected]
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