ImmuPharma clarifies next steps for phase 3 Lupuzor trial

(Sharecast News) - Specialist drug discovery and development company ImmuPharma updated the market on the new optimised international phase 3 trial of 'Lupuzor' in the potentially life-threatening auto-immune disease systemic lupus erythematosus (SLE) on Tuesday.
The AIM-traded firm said that, as it announced on 20 November, its licensing partner Avion Pharmaceuticals met with the US Food and Drug Administration (FDA) on 4 December for a 'type A' meeting request.

It said on Tuesday that Avion had received feedback from the FDA, and had now advised ImmuPharma of the programme of activities in respect to the next steps.

In response to the FDA input, Avion and ImmuPharma had plans to develop and validate a bioanalytical assay to confirm the clinical pharmacology and pharmacokinetic characterisations of Lupuzor, before starting the phase 3 trial.

A final guidance meeting between Avion and the FDA was being planned, at which Avion would submit the methodology for assessing pharmacokinetics as part of the trial.

That meeting, which was expected to take place in the second quarter, would also confirm previous submissions to FDA on the study design, clinical end points and approval process.

As it said on 20 November announcement, ImmuPharma said it had initiated the production of a new batch of Lupuzor clinical trial material specifically for the phase 3 trial, reporting on Tuesday that it would be ready for the start of the trial.

As part of the FDA feedback from the meeting on 4 December, the company said it had been clarified that a special protocol assessment would not be applicable, and that a conditional approval of Lupuzor, while the phase 3 trial is underway, had not been confirmed at the current time.

"We are extremely pleased to see the positive progress of Lupuzor towards the commencement of the international phase 3 trial with Avion," said chief executive officer Dimitri Dimitriou.

"We will continue to work closely with Avion over the next period to ensure the start of the phase 3 study remains on schedule for the second half of 2021."

At 1354 GMT, shares in ImmuPharma were down 15.44% at 10p.