Monday, March 30, 2015

Drugs in Clinical Pipeline: NRX-107

The orally active  N-methyl-D-aspartate (NMDA) receptor modulator, NRX-1074, is a follow up to Naurex's lead program, Rapastinel (GLYX-13), which recently demonstrated robust and durable antidepressant effects in a Phase 2b study as an intravenous adjunctive therapy in subjects with partial but inadequate response to existing antidepressants.

A single intravenous dose of NRX-1074 resulted in a statistically significant improvement in depression scores within 24 hours in a Phase 2 single-dose study in subjects with major depressive disorder (MDD).

Common Name: -
Synonyms: NRX-1074
IUPAC Name: -
CAS Number: -
Mechanism of Action: NMDA receptor modulator
Indication: Major Depressive Disorder
Development Stage: Phase II
Company: Naurex Pharma

Study Design

The randomized, double-blind, placebo-controlled Phase 2 study evaluated the efficacy and safety of a single intravenous dose of NRX-1074 in subjects with MDD. The study was conducted at 12 clinical centers in the United States. Subjects received one of three dose levels of NRX-1074 or placebo. The primary clinical efficacy measure was the HDRS-17, a standard scale for measuring depression severity, which was administered by off-site independent raters who were blinded to the protocol to ensure the quality and objectivity of the rating data. Safety was also assessed.

In the study, which enrolled approximately 140 subjects, NRX-1074 was well-tolerated with no drug-related serious adverse events reported and no subjects dropping out of the study due to adverse events. This safety profile was also observed in Phase 1 studies with both intravenous and oral NRX-1074 in healthy volunteers.

Findings from the Phase 2 single-dose study, along with oral and intravenous pharmacokinetic findings from Phase 1, will be used to select oral doses for a repeat-dose Phase 2 study. This upcoming randomized, double-blind, placebo-controlled multi-dose study will evaluate the efficacy and safety of repeated oral dosing of NRX-1074 administered as a monotherapy to subjects with MDD.

1. Naurex pipeline: NRX-1074