The US Food and Drug Administration (FDA) has given clearance to ANeuroTech’s investigational new drug (IND) application, allowing the company to carry out a Phase IIIb trial of ANT-01 as an adjunctive anti-depression drug for major depressive disorder (MDD).

ANT-01 is a low dose of pipamperone dihydrochloride with minimal or no side-effects. It is being developed as an orally administered drug to be taken once daily alongside a first-line antidepressant.

Due to start later this year, the double-blinded trial will evaluate the efficacy and safety of a 15mg dose of ANT-01 in combination with a first-line antidepressant against placebo in patients with MDD.

Patients who previously did not respond to selective noradrenaline serotonin reuptake inhibitor or selective serotonin reuptake inhibitor treatment are included in the study.

ANeuroTech intends to enrol more than 500 patients from sites in Europe, South America and the US.

The trial’s secondary endpoints will include the ability to feel pleasure and improvements in cognitive function.

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This will be the first anti-depression drug study to include these factors as endpoints.

Previous trials of ANT-01 have demonstrated the drug’s antidepressant activity, favourable safety profile and increase in the ability to feel pleasure and improvement in cognitive function.

ANeuroTech has received funding for the trial from international investment firm KOIS as part of a Series A financing round.

KOIS founder and managing partner Charles-Antoine Janssen said: “We are excited to support ANeuroTech as it embarks on its Phase IIIb pivotal programme.

“We look forward to working closely with them as they develop effective mental health treatments so desperately needed in today’s world.”

ANeuroTech founder and CEO Dr Erik Buntinx said: “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.”