Immupharma’s (LON:IMM) potential blockbuster treatment for Lupus, Lupuzor, has received a major boost after the US authorities reduced the number of phase III trials required for the new drug.
Lupuzor’s special protocol assessment (SPA) status has been amended by the US Food and Drug Administration (FDA) so that the number of patients for the phase III programme has been reduced to two studies with 200 patients each.
Phase III trials are normally carried out on much larger groups to assess efficacy, monitor side effects and compare with rival treatments.
Immupharma said the number of people in its trials is lower than other drugs in clinical trials for lupus and underpins the efficacy shown by Lupuzor. The design of the phase III study is also similar to that of the Immupharma phase IIb study, it said, adding it is now completing the manufacture of the drugs for the phase III trials.
Dr Robert Zimmer, Immupharma’s president and chief scientific officer, was delighted with the amended staus of Lupuzor.
“The amended SPA is a tremendous success and validation of our development efforts and the reduced number of patients, due to the unrivalled efficacy that Lupuzor has shown in phase IIb means that the cost of the phase III trial will also be substantially lower.
“The phase III programme has a similar design to our phase IIb study which demonstrated substantial efficacy compared to other drugs in Lupus clinical trials."