Lupuzor™ scheduled to commence international Phase 3 trial in Lupus patients in H2 20219th February 2021 - 11:22 am
ImmuPharma PLC (LSE:IMM) (Euronext Growth Brussels: ALIMM), the specialist drug discovery and development company, announces an update in respect to the new optimised international Phase 3 trial of Lupuzor™ in systemic lupus erythematosus (“SLE”), a potentially life-threatening auto-immune disease.
As indicated in the 20 November 2020 announcement, Avion Pharmaceuticals (“Avion”), ImmuPharma’s licensing partner for Lupuzor™, met with the US Food & Drug Administration (“FDA”) on 4 December 2020 for a Type ‘A’ Meeting Request.
Avion has received feedback from the FDA, and has now advised ImmuPharma of the programme of activities in respect to its commitment to schedule next steps.
In response to the FDA input, Avion, in partnership with ImmuPharma, has plans to develop and validate a bioanalytical assay, to confirm the clinical pharmacology and pharmacokinetic (“PK”) characterizations of Lupuzor™, prior to commencement of the Phase 3 trial.
A final guidance meeting between Avion and the FDA is being planned at which Avion will submit the methodology for assessing PK as part of the Phase 3 trial. This meeting, which is expected to take place in Q2, will also confirm previous submissions to FDA on the study design, clinical end points and approval process.
As indicated in the 20 November 2020 announcement, ImmuPharma initiated the production of a new batch of Lupuzor™ clinical trial material specifically for the Phase 3 trial and it can be confirmed that this will be ready for the start of the trial.
As part of the FDA feedback from the meeting on 4 December 2020, it has been clarified that a Special Protocol Assessment (“SPA”) will not be applicable and a conditional approval of Lupuzor™, whilst the Phase 3 trial is underway, has not been confirmed at this time.
Commenting on the announcement, Dimitri Dimitriou, CEO of ImmuPharma said
“We are extremely pleased to see the positive progress of Lupuzor™ towards the commencement of the international Phase 3 trial with Avion. 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 H2 2021.”
Art Deas, Chief Executive Officer, Avion Pharmaceuticals added: “Following continued positive dialogue with the FDA and with an agreed clinical and regulatory pathway over the next period, we look forward to moving Lupuzor™ ahead later this year.”
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