A combo of precision meds and diagnostics could disrupt mental healthcare

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For the 615 million people worldwide living with a mental health condition, treatment often falls short. More than 70% of those with depression don’t have success with the first antidepressant medication they try, and more than a third don’t find the right match even after multiple attempts.

Hans Eriksson, chief clinical development officer for HMNC Brain Health

Permission granted by Hans Eriksson.

“Although we have lots of treatments that do work for common mental disorders like depression, anxiety and schizophrenia, a worryingly large proportion of the patients suffering from these disorders do not get help,” says Hans Eriksson, chief clinical development officer for HMNC Brain Health , a precision psychiatric biopharma company with operations in the US and Germany.

But HMNC Brain Health is working to change that with its pipeline of psychiatric precision therapies — and perhaps as important — corresponding tests to identify which patients might benefit most from using them.

Although clinical-stage psychedelic-based compounds have gotten a lot of buzz for their potential to shakeup the mental healthcare space, HMNC’s precision medicine approach could also disrupt the standards of care. According to Eriksson, the treatments are based on the recognition that a single disorder, such as depression, may arise from numerous underlying causes and the current one-size-fits-all treatment approach isn’t working for many.

The company evolved from the research of one its founders, Dr. Florian Holsboer, currently the head of its scientific advisory board.

“His research was focused on the link between the stress management systems that we have in our bodies, a physiological way to cope with stress, and the link to depression,” Eriksson says. “That’s essentially where the science started.”

HMNC is now investigating two compounds to help treat depression caused by this faulty stress response. Nelivaptan, a phase 2-ready compound that’s part of the company’s Nelivabon program, which includes a diagnostics test, aims to treat people with a stress dysfunction caused by hyperactivity of a neuropeptide called vasopressin. The disfunction affects an estimated 30% of people with major depression, Eriksson says.

Nelivaptan was abandoned by Sanofi years ago, possibly because it didn’t perform as well in trials as antidepressant medications that were already on the market. HMNC resuscitated the approach, recognizing that the drug may have fallen short — not because it didn’t work, but because it was tested in a group that was too broad, Eriksson says.

A second compound, in the preclinical stage, is a corticotropin-releasing hormone (CRH) receptor 1 antagonist, licensed from the Japanese company, Eisai

These aren’t the only targeted mental health therapies in development. The company is also working on another medication for treatment-resistant depression. Its Ketabon program is focused on an oral prolonged-release formulation of ketamine that Eriksson says is less likely to produce side effects — including disturbing dissociative episodes or high blood pressure — common with other forms of ketamine therapy, such as Johnson & Johnson’s esketamine nasal spray (Spravato).

“We can get away from a one-size-fits-all approach that has been super dominant in psychiatry over many decades.”

Hans Eriksson

Chief clinical development officer, HMNC Brain Health

It also has another blood test designed to identify post-traumatic stress disorder (PTSD) early, so treatment can help prevent people from adopting harmful coping strategies. The test detects three biomarkers linked to dysfunction of the stress hormone, cortisol, and has been out-licensed to Polaris Genomics.

In addition, the company has commercialized a pharmacogenomic test in some European countries called ABCB1, that can help doctors predict a patient’s clinical response to common antidepressants.

“AI and machine learning were used to develop the companion diagnostic tests in the Nelivabon and Cortibon programs,” says Eriksson. “Sets of single nucleotide polymorphisms (SNPs) that can be evaluated to predict the outcome of interventions with vasopressin 1b-antagonists and CRH1R antagonists in depressed individuals were identified by this approach.”

Using these therapeutics and diagnostics together could prove to be a powerful combination in the mental health space.

“I think what makes us stand out is that we have a vision about how to develop not only novel medicines, but also develop the biological tools to identify the individuals that are more likely to respond to these novel medicines,” says Eriksson. “So, we can get away from a one-size-fits-all approach that has been super dominant in psychiatry over many decades.”

Here, Eriksson discusses how the company’s focus on personalized medicine is poised to change mental healthcare for the better over the next decade.

This interview has been edited for style, length and clarity.

PharmaVoice: What do you think it’s like for the individual patient who has to go through this trial-and-error process to find the right psychiatric medication?

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