08:00 Thu 21 Sep 2017
Immupharma PLC - Update on LupuzorT Pivotal Phase III Study
|
|
|
|
|
|
("
Update on Lupuzor™ Pivotal Phase III Study
· Study summary as at 15th
· 200 patients successfully recruited and randomised (dosed)
o all patients in the study have passed the 6 months stage
o 52 patients (26%) have completed 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,
"With an urgent need for a new treatment for Lupus which is safe and effective, we are observing an ever increasing focus from the market, the scientific community and patient groups on Lupuzor™ as we get closer to completing this pivotal Phase III study. We are looking forward with confidence to the outcome of the trial and to reporting, on track, the top line results in Q1 2018."
For more information on the trial please visit: www.ClinicalTrials.gov/lupuzor
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.
For further information please contact:
|
|
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:
This information is provided by RNS
The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of...
FOR OUR FULL DISCLAIMER CLICK HERE