Navitor Pharmaceuticals has commenced Part B of its Phase I clinical trial investigating NV-5138 for treatment-resistant depression (TRD).

NV-5138 is an orally-active small molecule designed to directly activate cellular metabolism modulator mTORC1, which is usually suppressed in the brain of people suffering from depression.

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The trial is designed to study the safety, tolerability and pharmacokinetics of NV-5138 in up to 88 healthy patients with TRD.

It features a multicentre, two-part, double-blind, placebo-controlled design.

Part A of the trial includes a single-ascending-dose phase and will see up to 48 healthy subjects randomly distributed in six cohorts to receive double-blind treatment.

“The positive results from the single ascending dose portion of our Phase I clinical study of NV-5138 in healthy volunteers support advancement into Part B.”

In Part B, Navitor will randomise nearly 40 patients diagnosed with TRD to receive either a single dose of NV-5138 or placebo.

The secondary efficacy objectives for Part B comprise standard depression rating and symptomology scores including the Montgomery-Åsberg Depression Rating Scale (MADRS).

Navitor Pharmaceuticals CEO Thomas Hughes said: “NV-5138’s direct activation of mTORC1 may deliver significant advantages over antidepressants that only indirectly activate this master metabolic control switch, offering the potential for rapid-acting antidepressant benefits without the psychotomimetic side effects and abuse potential observed with many N-methyl-D-aspartic-acid (NMDA) receptor-targeted therapeutics.

“The positive results from the single ascending dose portion of our Phase I clinical study of NV-5138 in healthy volunteers support advancement into Part B, and we are now evaluating a single dose of the compound in patients suffering with TRD.

“We look forward to the initial top-line data from this study in the middle of 2019.”