Date: 2015-04-22
Type of information: Milestone
Compound: SAGE-547
Company: Ligand Pharmaceuticals (USA - CA) Sage Therapeutics (USA - MA)
Therapeutic area: CNS diseases - Neurological diseases
Type agreement: milestone
Action mechanism: Allosteric modulator. SAGE-547 is an allosteric modulator of both synaptic and extra-synaptic GABAA receptors. GABAA receptors are widely regarded as validated drug targets for a variety of disorders, with decades of research and multiple approved drugs targeting these receptor systems. SAGE-547 is an intravenous agent in Phase 1/2 clinical development as an adjunctive therapy, a therapy combined with current therapeutic approaches, for the treatment of super-refractory status epilepticus (SRSE), as well as in exploratory Phase 2 clinical trials for the treatment of essential tremor and as an adjunctive therapy for the treatment of severe postpartum depression (PPD). In 2014, the FDA granted both Fast Track and orphan drug designation to SAGE-547 for the treatment of SRSE.
Disease: super-refractory status epilepticus (SRSE)
Details: * On April 22, 2015, Ligand Pharmaceuticals announced that it has earned a $500,000 milestone payment from Sage Therapeutics 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 (SRSE) 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 (NDA) submission. Ligand entered into a Captisol license agreement with SAGE for the development and commercialization of SAGE-547 in 2011. SAGE-547 is in development by SAGE Therapeutics for the treatment of SRSE. Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation.
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