Specialist drug discovery and development firm, ImmuPharma (LON: IMM) said they are set to commence an international Phase 3 trial of Lupuzor in patients with systemic lupus erythematosus, in the second half of 2021.
ImmuPharma shares are currently trading 15.81% lower at the time of writing, priced at 9.95p per share.
Avion Pharmaceuticals, ImmuPharma’s licensing partner for Lupuzor and the company leading the drug development, met with the US food and Drug Administration (FDA) for a Type ‘A' meeting on December 4th 2020.
After the meeting, Avion and ImmuPharma plan to develop and validate a bioanalytical assay to confirm the clinical pharmacology and pharmacokinetic characterisations of Lupuzor before the commencement of Phase 3 trials.
A final guidance meeting between Avion and the FDA is planned for Q2, where Avion will submit the method for assessing the pharmacokinetics, as part of the trial.
ImmuPharma previously announced it initiated production of a new batch of Lupuzor clinical trial material specifically for the Phase 3 trial and has confirmed that it will be ready for the start of the study.
The FDA has informed Avion that a special protocol assessment won't be applicable, and the conditional approval of Lupuzor has not been confirmed at this time.
“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,” said Dimitri Dimitrou, CEO of ImmuPharma.