SAGE-718: A First-in-Class N-Methyl-d-Aspartate Receptor Positive Allosteric Modulator for the Potential Treatment of Cognitive Impairment

J Med Chem. 2022 Jul 14;65(13):9063-9075. doi: 10.1021/acs.jmedchem.2c00313. Epub 2022 Jul 2.

Abstract

N-Methyl-d-aspartate receptor (NMDAR) positive allosteric modulators (PAMs) have received increased interest as a powerful mechanism of action to provide relief as therapies for CNS disorders. Sage Therapeutics has previously published the discovery of endogenous neuroactive steroid 24(S)-hydroxycholesterol as an NMDAR PAM. In this article, we detail the discovery of development candidate SAGE-718 (5), a potent and high intrinsic activity NMDAR PAM with an optimized pharmacokinetic profile for oral dosing. Compound 5 has completed phase 1 single ascending dose and multiple ascending dose clinical trials and is currently undergoing phase 2 clinical trials for treatment of cognitive impairment in Huntington's disease.

MeSH terms

  • Allosteric Regulation
  • Central Nervous System Diseases*
  • Cognitive Dysfunction* / drug therapy
  • Humans
  • Neurosteroids*
  • Receptors, N-Methyl-D-Aspartate / metabolism

Substances

  • Neurosteroids
  • Receptors, N-Methyl-D-Aspartate