Biomed Industries has reported data from its Phase IB pilot study of NA-831 to treat major depressive disorder (MDD).
The active reference, placebo-controlled, fixed-dose, randomised, double-blind study compared the safety, tolerability and efficacy of 20 and 40mg/d of NA-831 against placebo after six weeks of treatment.
A total of 32 adult patients with MDD were enrolled to receive the treatment.
Venlafaxine XR was used as the active reference during the study.
NA-831 was found to be well tolerated and efficacious in reducing anxious and depressive symptoms in patients who received the treatment for six weeks.
Fewer adverse events were observed in the treatment group receiving NA-831, as compared with currently available therapeutics.
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The difference between active treatment and placebo of ∼7 points on the Montgomery–Asberg Depression Rating Scale was observed.
It further notifies that the NA-831 arm showed a clinically relevant difference in response rates of 32.5% units against an average of 16% units for antidepressants, approved by the Food and Drug Administration and European health authorities.
Biomed Industries CEO Lloyd Tran said: “NA-831 can serve as a potential anti-depressive agent by increasing the extracellular levels of serotonin (5-HT), noradrenaline, dopamine, acetylcholine and histamine in the prefrontal cortex and hippocampus.
“Our previous trials of NA-831 showed proof of safety and efficacy for the treatment of Alzheimer’s disease. Those studies and this one also link the correlation between major depressive disorder and Alzheimer’s disease.
“We are excited about the results of this Phase IB study and are designing a protocol for a Phase III study treating MDD.”