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.
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.
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.”