ANeuroTech, a leader in the development of innovative mental health treatments with minimal or no side effects, today announces that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate a pivotal Phase IIIB trial of ANT-01 as an adjunctive anti-depression drug for Major Depressive Disorder (MDD). The Phase IIIB will include secondary endpoints of improvements in cognitive function and the ability to feel pleasure, the first time these have been included in an anti-depression drug clinical trial. ANeuroTech expects to begin the trial later this year.
More than 60% of people with depression and associated cognitive problems are not helped by existing first-line treatments or experience challenging side-effects (1). ANeuroTech is developing ANT-01 as an adjunctive anti-depression drug with minimal or no side-effects. ANT-01 is a low dose of an existing drug substance, pipamperone dihydrochloride, a typical antipsychotic developed and marketed at a high dose range for over 40 years in Europe for the treatment of psychotic disorders. Dr Erik Buntinx, CEO and Founder of ANeuroTech, discovered through his clinical practice that ANT-01 has a unique high selectivity and affinity for the serotonin 5-HT2A and dopamine D4DR brain receptors, and shows potential as an adjunctive treatment with fewer side effects. ANT-01 is being developed as a once-daily, orally administered drug to be taken in conjunction with a first-line antidepressant.
The pivotal, double-blinded Phase IIIB trial will assess the safety and efficacy of a single low (15mg) dose of ANT-01 combined with a first-line antidepressant versus placebo in MDD patients with insufficient response to selective serotonin reuptake inhibitor (SSRI) or selective noradrenaline serotonin reuptake inhibitor (SNRI) treatment. The Phase IIIB trial follows positive clinical data generated from earlier trials which demonstrated clinical evidence of antidepressant activity of ANT-01 with a favourable safety profile. The data also showed an increased ability to feel pleasure and improvement in cognitive function, which has not been demonstrated by any other adjunctive antidepressant molecule. The trial plans to recruit more than 500 patients at sites in the US, Europe and South America, and is expected to begin in 2023.
ANeuroTech has also secured funding from KOIS, an international impact investing company, as part of a Series A round. KOIS are experts in healthcare and life sciences investments, with a mission to turn projects with high societal and environmental impact into tangible investment propositions.
Dr Erik Buntinx, CEO and Founder of ANeuroTech, commented: "We are delighted to welcome KOIS to the ANeuroTech family. Their experience and track record in the healthcare and life sciences sectors will help us achieve our goal of bringing new options to patients suffering with depression."
Dr Buntinx continued: "Globally, there are 190 million people with MDD who do not respond well to antidepressants and we must do more to help them. The FDA’s endorsement of the ANT-01 Phase IIIB development programme recognises the excellent safety profile and strong efficacy data shown in studies so far, which also support, for the first time, the investigation of an adjunctive antidepressant drug for improvements in cognitive function and the ability to feel pleasure."
Charles-Antoine Janssen, Founder and Managing Partner, KOIS, said: "We are excited to support ANeuroTech as it embarks on its Phase IIIB pivotal programme. We have been impressed by the Company’s data and the deep experience of its management team. We look forward to working closely with them as they develop effective mental health treatments so desperately needed in today’s world."
(1) Rush AJ, Trivedi MH, Wisniewski SR, et al., Am J Psychiatry 2006;163:1905–17