ANeuroTech submits successfully Pivotal IND to the FDA for its phase IIIB development program for ANT-01 as an adjunctive anti-depression drug for Major Depressive Disorder.
ANT01 can enter the US market in 2028 with submitted Pivotal Program if successful.
Alken, Belgium – April 24, 2023: ANeuroTech, a leader in the development of innovative mental health treatments with minimal or no side effects, today announces that following pre-IND and Type C meetings with the US Food and Drug Administration (FDA), they have successfully submitted its pivotal Phase IIIB Initial New Drug (IND) application of ANT-01 as an adjunctive anti-depression drug for Major Depressive Disorder (MDD). The Phase IIIB includes key secondary endpoints on improvement in cognitive function and the ability to feel pleasure, the first time this has been included in an anti-depression drug clinical trial. It is expected that ANeuroTech will receive a ‘you may proceed letter’ from the FDA within the following period of 30 days.
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.
The pivotal Phase IIIB development program 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/noradrenaline re-uptake inhibitors (SSRIs/SNRIs) and other second-generation antidepressant treatments.
The Phase IIIB follows positive clinical data generated from earlier clinical trials and observations which demonstrated superior antidepressant activity of ANT-01 with a favorable safety profile. The data also showed an improvement in the ability to feel pleasure and in cognitive function, which has not been demonstrated by any other antidepressant molecule. This will be further explored in the Phase IIIB program, which will recruit up to 1.200 patients at several US and non-US sites and is planned to begin in Q42023 in a strategic collaboration with IQVIA.
Dr Erik Buntinx, CEO and Founder of ANeuroTech, commented: “Based on received FDA’s extensive feedback we could not only align the potential differentiating Target Product Profile of our lead compound ANT01, but also execute required additional studies to request for ‘green light’ from the FDA for implementing final pivotal clinical studies.
Of course, this represents a major milestone for ANeuroTech as this opens a straightforward path to the planned ANT01 New Drug Application in the US in 2028.
Dr Rudi Pauwels, Executive Chairman of ANeuroTech, commented: “ANT-01 has the potential to change the treatment paradigm for the ~190 million patients worldwide with MDD who are not currently helped by initial treatment with antidepressants. Erik’s passion and wealth of experience in treating patients with depression positions ANeuroTech at the forefront of mental health care, and I am excited about continuing this journey with the team, many of whom I had the pleasure of working with at the successful pharmaceutical company, Tibotec.”