Championing Novel Science

Reflecting on recent discussions about mental health and the impact of the COVID-19 pandemic, one feature that stands out for me is the word ‘isolation’. For most of us this is a new and challenging situation. However, for people living with mental health issues, this sense of isolation is not necessarily new, and if anything, has been made even harder as a result of everyday life restrictions and social distancing.

As Head of Medicines CNS Retinopathies & Emerging Areas, my team and I are looking at how we can better alleviate some of the day-to-day aspects of brain disorders. We are doing this by identifying ways to address the root causes of the problem. We are actively looking at how to target brain circuits that directly relate to these problems and explore pharmacological solutions in our studies.

Our pipeline of CNS compounds is expanding across a number of neuropsychiatric diseases such as schizophrenia, major depressive disorder (MDD) and most recently early stage research in borderline personality disorder. To complement the CNS research program, Boehringer Ingelheim is embracing opportunities through digital technological advances and incorporating them, for example, as part of our clinical trial design. I believe these positive advances in the field of telemedicine are not only relevant to current times but are here to stay! 

The need for new approaches and medical therapies in borderline personality disorder 

Applying our neurobiological approach to CNS research with digital advances, the team is researching new aspects of diseases to identify ways to treat and support people living with neuropsychiatric disorders. Borderline personality disorder is one of the most common personality disorders and individuals face many obstacles every day, which often result in poor social functioning, social isolation, and unemployment or long-term sick leave. They also have high rates of deliberate self-harm and a rate of completed suicide that is significantly higher than in the general population. This is no small problem and sadly is all too common. As physicians, our current treatment options are limited to help with coinciding symptoms such as depression or anxiety or to offer psychotherapy (which is not always easy to access). But to date no treatments are approved specifically for borderline personality disorder.

It therefore comes with a sense of anticipation that in 2020, the US Food and Drug Administration, after having reviewed our application summarizing current pre-clinical and clinical studies, granted fast track status to a new investigational compound targeting TRPC4/5 for the potential treatment of borderline personality disorder.^1,2 Our research is underway in borderline personality disorder, supported by the FDA’s fast-track designation, which helps to ensure clinical trials are progressed efficiently, to expedite this compound through to the next stages. Our hope is that through targeting brain circuits related to processing and regulation of emotions, such as TRPC4/5, the new compound may have potential to improve emotional control and regulation, a core symptom of borderline personality disorder.

What is the significance of the FDA’s fast-track designation?

For me this highlights two main points. It reinforces the urgent need to find solutions for those people living with borderline personality disorder, as this condition is wide-ranging and has a profound impact on the daily lives of many people. Secondly, it will allow for frequent interactions with the FDA with the goal of expediting development of the compound so that it can reach patients in the most efficient and timely manner possible.

Ultimately what does this mean for physicians and patients in the future?

As we move into phase II with our borderline personality disorder investigational compound, we are taking a positive step forward in our understanding of the underlying neurobiology of the condition. This is important for the future in how we might better manage borderline personality disorder. For patients it is clear that progress needs to be made to specifically improve key aspects of this condition. Ultimately, our goal will be to make a positive impact on the lives of people living with borderline personality disorder.

References

1 NCT03904576 https://clinicaltrials.gov/ct2/show/NCT03904576?id=NCT03904576&draw=2&rank=1&load=cart
2 NCT03854578 https://clinicaltrials.gov/ct2/show/NCT03854578?term=NCT03854578&draw=2&rank=1