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ANeuroTech's ANT-01, an Adjunctive Anti-Depression Drug, Receives FDA IND Approval for Pivotal Phase IIIB Trial

Tuesday, June 06, 2023

ANeuroTech, a pioneering company in the field of mental health treatments with minimal or no side effects, has received approval from the US Food and Drug Administration (FDA) to begin a pivotal Phase IIIB trial of their drug, ANT-01. This trial will investigate the potential of ANT-01 as an adjunctive treatment for Major Depressive Disorder (MDD), with a focus on secondary endpoints such as cognitive function and the ability to experience pleasure. This trial will be the first to include these endpoints in an anti-depression drug clinical trial. ANeuroTech plans to initiate the trial later this year.

Many individuals with depression and associated cognitive problems do not find relief from existing treatments or experience significant side effects. ANeuroTech aims to address these challenges by developing ANT-01 as an adjunctive anti-depression drug with minimal or no side effects. ANT-01 is a low dose of pipamperone dihydrochloride, a typical antipsychotic that has been used for several decades in Europe to treat psychotic disorders. Dr. Erik Buntinx, CEO and Founder of ANeuroTech, discovered the unique properties of ANT-01 through his clinical practice. It has shown high selectivity and affinity for the serotonin 5-HT2A and dopamine D4DR brain receptors, suggesting potential as an adjunctive treatment with reduced side effects. ANT-01 is designed to be taken orally once daily in conjunction with a first-line antidepressant.

The Phase IIIB trial will be pivotal and double-blinded, focusing on evaluating the safety and efficacy of a single low dose (15mg) of ANT-01 when combined with a first-line antidepressant compared to a placebo. The trial will specifically target MDD patients who have not responded adequately to selective serotonin reuptake inhibitor (SSRI) or selective noradrenaline serotonin reuptake inhibitor (SNRI) treatment. Positive clinical data from previous trials have already shown the antidepressant activity of ANT-01 with a favorable safety profile. Moreover, these trials have demonstrated improvements in the ability to experience pleasure and cognitive function, which sets ANT-01 apart from other adjunctive antidepressant molecules. The Phase IIIB trial aims to enroll over 500 patients across multiple sites in the US, Europe, and South America and is scheduled to commence in 2023.

To support their efforts, ANeuroTech has secured funding from KOIS, an international impact investing company specializing in healthcare and life sciences. KOIS focuses on identifying projects with significant societal and environmental impact and transforming them into viable investment opportunities. ANeuroTech's funding from KOIS is part of a Series A round, providing additional resources for their development of ANT-01.

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