A company working on treatments for people with mental health issues has had positive feedback from the development program of an anti-depressant targeting major depressive disorder (MDD).
ANeuroTech has just announced that after a successful pre-Investigational New Drug Application (IND) meeting, the US Food and Drug Administration (FDA) has given positive feedback on its pivotal phase 3b development program of ANT-01 as an adjunctive anti-depression drug for MDD.
The ability to feel pleasure, used as a measure for the first time, and an improvement in cognitive function, have been included as a secondary endpoint in the phase 3b part of the clinical trial.
ANeuroTech will file for IND in the fourth quarter and apply for FDA Fast-Track Designation at the same time.
More than 60% of people with depression and associated cognitive problems are not helped by initial treatments or experience challenging side-effects.
ANeuroTech is developing ANT-01 as an adjunctive anti-depression drug with minimal or no side-effects. It is a low dose of an existing drug substance, pipamperone dihydrochloride, a typical antipsychotic developed by the late Dr Paul Janssen (founder of Janssen Pharmaceutica which merged with Johnson & Johnson) and marketed for more than 40 years in Europe at a high dose range for the treatment of psychotic disorders.
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.
Buntinx said: “The FDA’s positive feedback for our phase 3b development program recognizes the excellent safety profile and strong efficacy data shown in studies of ANT-01 to date and is an important milestone as we prepare to initiate the study next year.”
The pivotal phase 3b 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 re-uptake inhibitor (SSRI) or selective noradrenaline serotonin re-uptake inhibitor (SNRI) treatment.
The phase 3b follows positive clinical data generated from earlier trials which the company says 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 3b program, which will recruit 300 patients at a number of US sites and is planned to begin in 2023.
ANeuroTech also announced that seasoned biotech entrepreneur, Rudi Pauwels, has joined the board of directors as executive chairman. Pauwels has more than 30 years’ experience in the biotech sector and has co-founded several successful biotech companies including Tibotec, Virco, Galapagos Genomics and Biocartis. He holds a PhD in Pharmaceutical Sciences from KU Leuven, where he met and was mentored by Janssen.
Buntix added: “It’s a great time to welcome Rudi to the team and partner with him to revitalize the unique drug discovery legacy of our mutual mentor, the late Dr Paul Janssen.”
Pauwels said: “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.”