08:00 Wed 17 May 2017
Immupharma PLC - Update on Lupuzor Phase III Study
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Update on Lupuzor™ Pivotal Phase III Study
Study Summary
· 200 patients successfully recruited and randomised (dosed)
· 7 Countries and 28 sites are participating in the study
o US: 11 sites with 70 patients
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· Study status as at
o all 200 patients have passed the 3 months stage
o over 80% of patients (166) have passed 6 months
o 49 patients have passed the 9 months stage
o 28 patients have passed the full 12 months of the study
· Continued robust safety record which remains consistent with Lupuzor™'s product profile as shown in its previous Phase IIb study
· Top line results remain on track to be reported in Q1 2018
Commenting on the trial update,
Putting this data into context, key milestones have been achieved with all 200 patients passing the three months stage whilst 28 patients have now passed the full 12 months of the study. We are now in important new territory with over 80% of patients having had exposure to Lupuzor™ for over six months, compared to our Phase IIb three month study, whilst still maintaining an excellent safety profile.
With the study on track to report top line results in Q1 2018, we look forward to providing shareholders with further updates on this pivotal Phase III study as it progresses through 2017."
For more information on the trial please visit: www.ClinicalTrials.gov/lupuzor
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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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