FDA Grants ImmuPharma ammended SPA for Lupuzor Phase III; Company Progresses Development Activities12th August 2013 - 10:50 am
ImmuPharma plc (LSE:IMM) (“ImmuPharma” or the “Company” or the “Group”), the specialist drug discovery and development company, is delighted to announce that following its discussions with the FDA (the US Food & Drug Administration), it has been granted an updated SPA (Special Protocol Assessment) for Lupuzor.
Under the new SPA, the necessary number of patients for the phase III programme has been reduced to 2 studies with 200 patients each. This number is lower compared to other drugs in clinical trials for lupus and underpins the significant efficacy shown by Lupuzor. Furthermore, the design of the phase III study is similar to that of the ImmuPharma phase IIb study.
ImmuPharma is now completing the manufacturing of the phase III drug supplies as well as the CMC (chemistry manufacturing and controls) section proving appropriate stability of the drug product.
Commenting on the announcement, Dr Robert Zimmer, President & Chief Scientific Officer of ImmuPharma, said: “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.”