ANeuroTech shares plans for major depressive disorder pivotal programme

Belgium-headquartered ANeuroTech is participating in a Series B round, which will raise up to $150m to power the pivotal programme of its lead candidate ANT01 for use as an adjunctive treatment for major depressive disorder (MDD).

This includes the company’s upcoming Phase IIIb trial, but also another Phase III study and a long-term safety trial, said ANeuroTech CEO Eric Buntinx in an interview with Pharmaceutical Technology.

The company has already contacted funds based in Europe and in the US, said Buntinx. He added that ANeuroTech is speaking to more than ten different parties. The company plans to finish the round by September or October at the latest.

ANeuroTech previously raised an undisclosed amount of capital as part of a Series A round, which featured investment from impact finance firm KOIS.

ANT01 consists of a 15mg dose of pipamperone, which is a serotonin-2A and dopamine-4 blocker, per the company’s website. While the drug is marketed in other countries, it is not registered in the US.

Since some of the patients with major clinical depression do not respond sufficiently to one or more antidepressants, there is a need for new treatments, said Buntinx. Due to this, adjunctive treatments are used as part of a patient’s treatment regimen. But while available adjunctive options work well, they come at the cost of safety, said Buntinx, and ANT01 could offer these benefits without additional side effects.  

ANeuroTech will enrol the first patient in its Phase IIIb trial of ANT01 in MDD in Q4 2023, said Buntinx. Earlier this month, the US Food and Drug Administration (FDA) approved the drug’s investigational new drug application (IND) to start this trial.

Buntinx added that the study will enrol up to 600 patients across Europe, South America, and the US. Overall, the pivotal programme could enrol 1,500 patients, with more than half of them aimed for recruitment in the US.

The trial will measure the reduction of the total score measured through the Montgomery-Asberg Depression Rating Scale (MADRS) after six weeks as a primary endpoint. The trial will be nine weeks long, with a week of screening and the primary endpoint evaluation being done in the sixth week.

Buntinx commented that the trial will measure the patients’ experience of anhedonia or the inability to experience pleasure via the Snaith-Hamilton Pleasure Scale (SHAPS) as one of the key secondary endpoints. The trial will also measure the patients’ cognition as an additional secondary endpoint.

The company aims to run an interim analysis of the trial by mid-2024 at the very latest. ANeurotech plans to run a second, identical Phase III trial in this indication after the interim analysis. Additionally, the company plans to run a further open-label safety study that will serve as a long-term trial mostly made of past patients from the other two trials.