Gut-Brain Axis Therapy NeuroBiome Completes Phase II Trial: Specific Probiotic Blend Significantly Improves Major Depression

Gut-Brain Axis Therapy NeuroBiome Completes Phase II Trial: Specific Probiotic Blend Significantly Improves Major Depression

Israeli biotech company Biomica published Phase II clinical trial results for its NeuroBiome therapy on November 25. NeuroBiome is an oral probiotic capsule containing six genomically screened bacterial strains that modulate the gut microbiome to influence the brain's production of neurotransmitters, particularly serotonin and GABA.

The trial enrolled 280 patients with major depressive disorder who had not responded to two or more antidepressant medications. Patients were randomized into NeuroBiome and placebo groups. After 8 weeks, the NeuroBiome group's Hamilton Depression Rating Scale (HAM-D) scores dropped by an average of 45% (from 24 to 13), compared to an 18% reduction in the placebo group. More importantly, 38% of patients in the NeuroBiome group achieved full remission (HAM-D score below 7).

Biomica's Chief Scientific Officer, Dr. Elran Haber, noted that NeuroBiome's onset of action is approximately 2-3 weeks, faster than conventional antidepressants (4-6 weeks), and no common drug side effects such as weight gain or sexual dysfunction were observed. "The gut-brain axis is the next frontier in psychiatry," Haber said. Phase III clinical trials are planned for the first quarter of 2031.