Ligand Pharmaceuticals has announced that its partner Sage Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for the Captisol-enabled SAGE-547 to treat status epilepticus.

An allosteric modulator of GABAA receptors, SAGE-547 is being evaluated in Phase I/II clinical trial for treatment of adult patients with refractory status epilepticus who have not responded to standard regimens (super-refractory status epilepticus).

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The Phase I/II study has enrolled four patients and preliminary data indicate that these patients met the key efficacy endpoint. Each was successfully weaned off the anesthetic agent while SAGE-547 was being administered.

“SAGE-547 is being evaluated in Phase I/II clinical trial for treatment of adult patients with refractory status epilepticus who have not responded to standard regimens.”

Until now, no drug-related serious adverse events have been reported in the four patients.

Ligand president and CEO John Higgins said: “Sage illustrates the important role Ligand can play in helping our partners to develop new drug candidates.

“Whether it’s licensing our technology such as Captisol or our novel research discoveries, by conferring our rights under licences, new R&D programmes can advance efficiently with dedicated resources and funding.

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“Each of these licences holds potential for new medical and commercial markets to be opened up, with Ligand participating in the economics of a successful programme.”

Sage and Ligand entered into a platform Captisol license agreement in 2011 for development of Captisol-enabled therapeutics for a broad range of debilitating central nervous system conditions. Elements of the agreement with Sage were expanded in 2014.

Captisol is a chemically modified cyclodextrin with a structure designed to optimise the solubility and stability of drugs.