LONDON (ShareCast) - (ShareCast News) - Specialist drug discovery and development company ImmuPharma confirmed a further update on its lead programme for a potential breakthrough compound for lupus, Lupuzor, on Tuesday.
The AIM-traded firm had announced on 21 September that that all patients in the company's pivotal Phase III Lupuzor study had passed the six month stage, with 52 patients - or 26% - having now completed the full 12 months of the study.

It said that importantly, that announcement also confirmed the continuation of a robust safety record and that the trial remained on track to report the top line results by the end of the first quarter of 2018.

With the trial progressing as planned, ImmuPharma said it was planning ahead in anticipation of the trial's successful outcome.

In consultation with its regulatory advisors, the company said it was now progressing the completion of the regulatory dossiers in preparation for submission to the Food and Drug Administration (FDA) and European Medicines Agency (EMA).

That included the finalisation of the Drug Master File, and in particular the manufacture of commercial batches of the Lupuzor drug.

Immupharma said those would be manufactured according to the described procedures in the DMF, to be ready for inclusion in the regulatory submissions.

"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," said Immupharma president and chief scientific officer Robert Zimmer.

"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."

Email this article to a friend

or share it with one of these popular networks:

• DIGG
• FACEBOOK
• STUMBLEUPON
• MIXX
• YAHOO BUZZ
• DELICIOUS
• REDDIT
• NEWSVINE