ImmuPharma initiates preparation of Lupuzor’s™ regulatory submissions27th September 2017 - 9:57 am
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is pleased to confirm a further update on Lupuzor™ its lead programme for the potential breakthrough compound for Lupus, the life threatening auto-immune disease.
On 21 September 2017 ImmuPharma announced that that all patients in the Company’s pivotal Phase III Lupuzor™ study had passed the six month stage, with 52 patients (26%) having now completed the full 12 months of the study. Importantly this announcement also confirmed the continuation of a robust safety record and that the trial remains on track to report the top line results by the end of Q1 2018.
With the trial progressing as planned, ImmuPharma is planning ahead in anticipation of the trial’s successful outcome. In consultation with its regulatory advisors, the Company is now progressing the completion of the regulatory dossiers in preparation for submission to the Food and Drug Administration (FDA) and European Medicines Agency (EMA). This includes the finalisation of the Drug Master File (‘DMF’) and in particular the manufacture of commercial batches of the Lupuzor™ drug. These will be manufactured according to the described procedures in the DMF, to be ready for inclusion in these regulatory submissions.
Commenting on the announcement, Robert Zimmer MD, PhD President and Chief Scientific Officer said:
“We are delighted with the progress of the Lupuzor™ Phase III trial and are looking forward with confidence and planning for a successful outcome for the study. In consultation with our regulatory advisors, we are now completing the required regulatory dossiers to be submitted to the FDA and EMA as part of their approval process. We are keen to ensure that there are no delays in submission to enable us to fully exploit our ‘fast track’ status, previously granted by the FDA, so that the Company’s package will be reviewed within 6 months of submission.”
For more information on the trial please visit: www.ClinicalTrials.gov (Search term ‘Lupuzor’).
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.