The emerging golden era of neuroscience [Sponsored]

Bill Martin is the Global Therapeutic Area Head of Neuroscience at The Janssen Pharmaceutical Companies of Johnson & Johnson. In an interview, he shared some of the promising developments in the neuroscience space, such as the rise of neuro-immunology, new ways to measure and monitor the potential for schizophrenia relapse, and the industry’s embrace of digital health tools to support drug development.

Bill Martin

Given how relatively small Janssen’s Neuroscience pipeline is compared to other sectors, how do you see this part of the company growing and becoming a key driver within Janssen’s portfolio? 

We see neuroscience as one of the key growth engines of Janssen. We have a proud, 60-year heritage in neuroscience. In fact, our namesake, Dr. Paul Janssen, developed breakthrough treatments for schizophrenia, which revolutionized the standard of care at the time. Over the course of his career, he developed more than 20 treatments for a broad range of nervous system disorders. 

Today, a truly golden era in neuroscience is emerging which is being defined by increased precision. We are using more precise ways to identify targets of interest and patients who are the most suitable for a particular treatment. We also can be more precise in how we modulate those targets and measure therapeutic response.

Our growth strategy is to move beyond our core focus of psychiatry to harness the scientific advances in human genetics, data science, biomarkers, and neuro-immunology – the intersection of neuroscience and immunology. We plan to expand our global commercial portfolio by introducing new therapies for people living with neurological, neurodegenerative, and autoantibody-driven diseases. 

What’s an example of how Janssen is working in the neuro-immunology space?

One recent example is Johnson & Johnson’s acquisition of Momenta Pharmaceuticals in August 2020. This deal gave us an opportunity to broaden our leadership in immune-mediated diseases to drive further growth. As part of the acquisition, we gained full global rights to a molecule to treat autoantibody-driven diseases. While there are many immunology indications within that space, there are multiple neuroscience indications as well. For example, we are researching patients with myasthenia gravis, an autoimmune neuromuscular disorder that can be difficult to diagnose.

This investigational treatment recently received its fourth orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of chronic inflammatory demyelinating polyneuropathy, or CIDP – a rare neurological disorder of the peripheral nerves characterized by gradually increasing sensory loss and weakness associated with loss of reflexes. 

In March of this year, your drug for the treatment of adults with relapsing forms of multiple sclerosis secured FDA approval. Can you talk about the significance of this approval and how it informs Janssen’s approach to drug development generally and in neuroscience specifically?

The significance of receiving the approval of our multiple sclerosis (MS) treatment, both from the FDA as well as from the European Commission this year, is based on more than 10 years of cumulative clinical research. This research included a head-to-head study which found the superiority of our product over another oral disease-modifying treatment in reducing annual relapse rates in patients with relapsing MS. These results showcased why studies have suggested patients can benefit from additional therapies to gain control of their disease. 

I think that, beyond the molecule itself and what it can deliver to patients, it’s important to recognize that this represents our re-entry into neurology and reinvigorates our commitment to developing solutions across the full neuroscience spectrum. This milestone also fits into our overall strategy by helping us expand the global clinical footprint beyond psychiatry.

Do you see in-licensing or acquisitions as a way to boost Janssen’s neuroscience pipeline? 

Licensing, when it makes sense strategically, is a means for growth. In fact, J&J has a strong legacy of working with companies, either through collaboration or through acquisitions, to help grow our pipeline. We remain open to exploring other opportunities that would help us strategically move into patient populations that we might not otherwise be able to access and into deeper stages of clinical development, compared with some of our internally grown assets.

What are your plans for therapeutics for neurodegenerative disorders?

We have a strong focus on Alzheimer’s disease, including programs focused on the tau protein. It’s a small protein that’s predominantly found in brain cells, and that accumulates in the genetic disorder. We have two ongoing programs. One is a passive immunotherapy approach – a monoclonal antibody that targets the mid-domain of the tau protein. It is the most advanced therapy directed against the mid-domain, as it recognizes an epitope in the pathological region and is specific to the phosphorylation at that epitope that occurs in Alzheimer’s disease. We also have a tau vaccine program, currently in Phase 1b/2a, that we’re running in collaboration with AC Immune.

In a recent interview, you said that Janssen is closing the translational gaps that have hindered the industry in the past. How are you doing that?

Historically, a poor understanding of brain diseases has really been a barrier to the development of novel therapeutics. Today, we see the opportunity to close the translational gap by systematically incorporating data science and biomarkers into all phases of development. We’re advancing our understanding of these disorders and leveraging biomarkers to enable better patient stratification and more accurate measures of response. This has been a key element to unraveling disease complexity, and patient heterogeneity that we think has been significant barriers to advancing treatments. These translational opportunities are probably stronger and better than they’ve ever been.

In the same interview, you talked about using digital tools that you and other pharma companies are applying to neuroscience. Can you expand on which digital tools you are referring to and how they are giving companies like yours an edge?

Let’s start by recognizing that digital health solutions have taken off across healthcare. In neuroscience, the potential impact is high because the digital tools interact directly with the output and input of the human brain. We and others have found that there’s disease-relevant information contained, for example, within speech, and within video. By using smartphones to collect data based on tasks deployed digitally, we can put this information into context for each person. These data sources can help give a complete picture of individual patients.

In one instance, we’ve been collecting digital phenotype data at scale, in a real-world setting, through a partnership with a data science and digital health company. Together, we are developing an app that enables digital data to be integrated with psychiatric electronic medical records. I’d also draw your attention to numerous examples where these digital tools are making a difference, such as the European Innovative Medicine Initiative’s (IMI) RADAR_CNS program. This program aims to develop new ways of monitoring major depressive disorders, epilepsy, and multiple sclerosis using wearable devices and smartphone technology. We’re also doing work to measure and monitor the potential for relapse in people with schizophrenia.

Is the data you are collecting with digital tools being applied at the R&D stage or to support drugs you currently have on the market?

Both. Let’s look at relapse prediction. As you know, individuals who have a psychotic break are going to be discharged from an emergency room or hospital. What if we can actually give them smartphones with health and wellness wristbands or watches? By being able to capture this ongoing physiological information, the hope is that we will be able to evaluate or identify a signature that would predict relapse and then intervene, obviously, before that relapse occurs. Our goal is to predict and pre-empt or intervene with treatments very, very early to maximize patient outcomes.

Has the growing trend of decentralized clinical trials made it any easier/faster to recruit patients for studies in neurodegenerative diseases? 

Decentralized clinical trials clearly offer several potential advantages over traditional approaches. They’re positioned to help improve patient engagement, which, by meeting patients where they are, could make clinical studies more accessible and convenient. It also offers the opportunity to expand representation in clinical trials across all groups of patients.

Decentralized clinical trials also provide an opportunity to standardize the use of these digital technologies in both the measurement of disease and response to treatment. The idea is that decentralized trials could be faster and more effective than traditional, site-based studies. 

But I think there’s cautious optimism for these reasons. First, we need to ensure good clinical research practices (GCP) – data privacy, integrity, and quality throughout the process. We also need to work with networks and companies that are innovating in this space. More specifically, I think the challenges of recruiting for clinical trials in neurodegenerative diseases remain high, and these challenges cannot be solved merely by decentralized clinical trials alone. 

When you begin to use these more remote monitoring tools, you’re inevitably going to have a higher screen failure rate, almost by design. So, the digital technologies and low friction pre-screening methods can help reduce that burden and identify the right patients to enroll.

I would say, however, that the tradeoff for increased precision today is that it is taking longer to get clinical trials up and running properly. There are many benefits to decentralized trials, but it’s important to note that while they are certainly part of the solution, they are not the entire solution. We need to continue to ensure clinical trials are executed faster and at a lower cost to give us the advantage of recruitment that we look to experience. This will get us closer to our goal at Janssen – to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented.

Photo: DrAfter123, Getty Images

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