Navitor Pharmaceuticals has initiated a Phase l clinical trial to investigate the safety, tolerability and pharmacokinetics of NV-5138 in treatment-resistant depression (TRD).

As part of the multicentre, two-part, double-blind, placebo-controlled trial, up to 88 subjects will be enrolled, including healthy volunteers and TRD patients.

In Part A, which is the single-ascending-dose portion of the trial, up to 48 healthy volunteers will be randomly distributed to receive a double-blind treatment in six dosage-level cohorts.

In each of these cohorts, six subjects will be randomised to receive NV-5138, while two subjects will be randomised to receive a placebo.

“Initiation of this clinical study is supported by preclinical studies demonstrating the potential of NV-5138 as an oral treatment for depression.”

The trial’s Part B will enrol around 40 TRD patients, who will be randomly assigned to receive double-blind treatment at a single dosage level that will be established based on data from Part A of the study.

This part will also analyse a number of prespecified outcome measures including standard depression rating and symptomology scores such as the Montgomery-Åsberg Depression Rating Scale (MADRS).

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Navitor Pharmaceuticals clinical advisory board member Maurizio Fava said: “Initiation of this clinical study is supported by preclinical studies demonstrating the potential of NV-5138 as an oral treatment for depression through activation of mTORC1, a cellular pathway that appears to underlie the beneficial effects of several in a new class of rapidly acting anti-depressants.”

TRD is a subset of major depressive disorder (MDD) that includes depressive episodes that are not adequately controlled by standard antidepressant therapies, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs).

According to Navitor, NV-5138 may offer future potential for the treatment of MDD.