Sage Therapeutics’ SAGE-718 has been awarded the orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of Huntington’s Disease.
The neuropsychiatric drug is being developed as a potential oral therapy for cognitive disorders associated with N-methyl-D-aspartate (NMDA) receptor dysfunction and is currently undergoing multiple clinical studies in several disease areas.
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An orphan drug designation is granted by the FDA Office of Orphan Products Development. The designation gives a biotech additional funding for clinical development, tax breaks, and a limited period of market exclusivity, amongst other benefits.
SAGE-718 is being studied in two placebo-controlled Phase II studies and a Phase III open-label safety study in the potential lead indication of Huntington’s Disease-related cognitive impairment.
It is also currently involved in Phase II placebo-controlled studies in mild cognitive impairment associated with Parkinson’s disease (NCT04476017) and mild cognitive impairment alongside mild dementia due to Alzheimer’s disease (NCT05358821).
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Laura Gault, chief medical officer at Sage Therapeutics, said : “There are currently no approved treatments to address cognitive impairment for people with HD and a growing sense of urgency among researchers and people living with HD to address cognitive impairment early so that patients can maintain independence longer.”
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By GlobalDataSAGE-718 had previously received Fast Track Designation for its use in HD. The good news for Sage Therapeutics comes after it announced that it would be reducing its workforce by 40% after major depressive disorder treatment, Zurzuvae, was rejected by the FDA.
