Sage Therapeutics receives fast track designation for SAGE-547 SAGE Therapeutics announced that the FDA has granted fast track designation to the SAGE-547 development program. SAGE-547 is an allosteric modulator of GABAA receptors in development for the treatment of adult patients with refractory status epilepticus who have not responded to standard regimens. SAGE is currently evaluating SAGE-547 in a Phase 1/2 clinical trial for the treatment of SRSE. Preliminary data indicate that the first four patients enrolled in the clinical trial met the key efficacy endpoint, in that each was successfully weaned off his or her anesthetic agent while SAGE-547 was being administered. There have also been no reported drug-related serious adverse events in these four patients to date.
Ligand earns milestone payment from Sage Therapeutics for SAGE-547 Ligand (LGND) announced that it has earned a $500,000 milestone payment from SAGE Therapeutics (SAGE) relating to the treatment of the first patient in SAGE’s Phase 3 open-label expanded access protocol, designated Study 302. Study 302 is designed to offer SAGE-547 to patients affected by super-refractory status epilepticus and to evaluate the safety of SAGE-547 in patients with SRSE. SAGE has reported that the results from this clinical trial, along with results from SAGE's planned Phase 3 placebo-controlled clinical trial - called the STATUS Trial – and other clinical data obtained from the SAGE-547 development program are intended to form the basis of a New Drug Application submission.