RNS : FOR IMMEDIATE RELEASE
("ImmuPharma" or the "Company")
ImmuPharma initiates preparation of Lupuzor's™ regulatory submissions
On
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
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.
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Notes to Editors
ImmuPharma is a pharmaceutical development company listed since 2006 on AIM of the
Lupuzor™
Lupuzor™ (also referred to as Forigerimod, or P140) is ImmuPharma's lead compound and a potential treatment for lupus (or Systemic Lupus Erythematosus), a chronic, potentially life-threatening auto-immune disease. Lupuzor™ has a novel mechanism of action aimed at modulating the body's immune system so that it does not attack healthy cells, and avoids causing adverse side effects. It has the potential to halt the progression of the disease in a substantial proportion of patients.
Lupuzor™ has been granted Fast Track status by the US FDA and approval to start Phase III under Special Protocol Assessment (SPA). This SPA was subsequently amended due to its strong safety and efficacy profile to allow for a reduced number of patients in the pivotal Phase III trial thereby reducing the projected cost and time of development considerably.
The pivotal Phase III clinical study is entitled "A 52-Week, Randomized, Double-Blind,
Commercial Opportunity
There are an estimated five million people globally suffering from Lupus, with approximately 1.5 million patients in the US, Europe and Japan (Source:
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