Naurex and NRX-1074

Naurex reported today that the first efficacy trial for NRX-1074, using a single-dose IV administration of a compound that will be delivered orally from now on, established a remarkable degree of immediate impact. At 24 hours post-injection of the highest dose (and unlike GlyX-13, NRX-1074 does not have an inverted-U dose-response curve), the mean reduction in Hamilton scores was 14 points, the effect size was .88.  The effect size itself, just 24 hours later, is impressive compared to current antidepressants. It was also pleasantly surprising that 72% of patients receiving NRX-1074 showed a ‘clinically meaningful’ response, given that in rapastinel/GlyX-13’s PhIIb, only about half of the patients appeared to be treatment-responsive. The usual caveats–small treatment samples for each of the three doses, 35 patients; just a single-dose readout; IV delivery of this oral compound–do apply, and the data release did not offer anything regarding the durability of the antidepressant response. However, durability is far less important here than it was with IV GlyX-13, for which minimizing the frequency of re-infusion would be an important treatment consideration. These data at 24 hours suggest that once-daily administration would be viable, the sweet spot for an oral antidepressant. The next clinical step (starting this spring) will be a repeated-dose, oral administration trial of NRX-1074, as monotherapy– in contrast to GlyX-13, being developed as an adjunct. As to the next corporate development step, it seems a near-certainty that Naurex will go the IPO route to funding their ambitious clinical development agenda–the question to us is not whether, but when.

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