ImmuPharma’s US partner to meet with FDA in December regarding Lupuzor™ trial
has announced that Avion Pharmaceuticals, its licensing partner for Lupuzor™, will meet with the US Food & Drug Administration ("FDA") next month to discuss guidance on the forthcoming international Phase 3 trial of Lupuzor™ in Lupus patients.
The specialist drug discovery and development company said the US FDA has now confirmed the date of 4 December 2020 for a Type 'A' Meeting Request, with Avion Pharmaceuticals.
As part of the Type 'A' Meeting, Avion has asked the US FDA for guidance on several aspects of the study design, clinical end points and approval process for Lupuzor™ as well as its consideration for a conditional approval of Lupuzor™, whilst the Phase 3 trial is underway.
ImmuPharma and Avion have worked closely on the clinical trial design and strategy since they signed an agreement in November 2019 for Lupuzor™, with Avion Pharmaceuticals agreeing to fund a new international Phase III trial and commercialise the treatment in the US.
Avion submitted a Special Protocol Assessment ("SPA") request to the FDA for Lupuzor™, a novel peptide therapeutic for the treatment of systemic lupus erythematosus, in July 2020.
Shares in ImmuPharma have ticked up nearly 5% over the past month to open this morning 11.16% higher at 11.95p following the announcement.
Last week, ImmuPharma reported that Avion Pharmaceuticals had asked the FDA to consider the conditional approval of Lupuzor ahead of the completion of the final-stage clinical study.
A conditional approval, which would allow Lupuzor™ to be marketed before the completion of a new Phase 3, would be based on the ‘clinically significant data’ generated in the completed Phase 2 and 3 clinical trials to date that showed the treatment was ‘safe and well tolerated.’
In anticipation of the start of the new Phase 3 clinical trial, ImmuPharma said last week that it had initiated the production of a new batch of the Lupuzor™ drug specifically for the trial.
Lupuzor™ is ImmuPharma's lead compound and an autophagy immunomodulator for systemic lupus erythematosus (SLE or lupus) a potentially life-threatening auto-immune disease. It also has the potential for treating other auto-immune diseases other than lupus.
"ImmuPharma and Avion are delighted that the FDA are expediting the Type 'A' Meeting for early December 2020,” commented Dimitri Dimitriou, Chief Executive of ImmuPharma.
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