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Novartis deploys digital therapies in bid for new schizophrenia medicines

Novartis AG is paging the digital therapist in an effort to develop new treatments for schizophrenia and depression, disorders that have challenged drugmakers for decades.

One of the main hurdles faced by scientists researching new drugs for such conditions is how to standardize large drug trials in order to show effectiveness, according to Ricardo Dolmetsch, global head of neuroscience at the Cambridge, Mass.-based Novartis Institutes for BioMedical Research, or NIBR, which the Swiss pharmaceutical giant calls its "innovation engine."

Until recently, a typical clinical trial would entail patients taking the experimental drug and undergoing a course of psychotherapy, a process whereby psychiatrists periodically attempt to assess its effect on the patient by measuring mood, emotions and behavior — all "soft targets" that are hard to quantify, especially with so-called pencil-and-paper tests devised in the 1970s.

"We need better ways of measuring behavior on a continuous basis if we are going to de-risk drug development in psychiatry and be able to do smaller trials," Dolmetsch, who is currently an adjunct professor of neurobiology at Stanford University School of Medicine, told S&P Global Market Intelligence in an interview. "If we can have a standardized way of providing that, that helps us to determine whether our drugs really work."

SNL Image

Ricardo Dolmetsch

Source: Novartis

An alliance struck by Basel, Switzerland-based Novartis with Pear Therapeutics Inc. on March 1 looks set to change the way these trials are carried out.

Pear has developed a digital therapeutic called Thrive, which offers a version of cognitive behavioral therapy, a form of treatment designed to change unhelpful thinking patterns. People suffering from schizophrenia can use Thrive at any time on any mobile device via a combination of text, video and audio.

An actual therapist can monitor a patient's state of mind on a regular basis using a dashboard displaying the amount of time spent on the various modules and topics that the patient is interacting with via Thrive. Such prompts have the added advantage of collating a large amount of data to show how effective the accompanying medicine is — and in doing so, can help to standardize clinical trials by providing consistent feedback.

"What we hope to see in digital therapeutics is synergistic interaction between the drug and the digital therapy, so that you get a 1 plus 1 equals 3 effect," Novartis' head of digital therapeutics at NIBR, Joris Van Dam, said in an interview. "The digital therapeutic, for example, in schizophrenia, could talk to patients about their beliefs around medication, which is a big driver of non-adherence in medication."

In addition to the cost and size of clinical trials, the lack of major advances in psychiatric research in recent years can be partly attributed to the multitude of biological targets for medicines.

The complexity of discovering molecules that are effective, safe and can cross the blood-brain barrier — a membrane that separates the blood from the cerebrospinal fluid and prevents certain materials from entering the brain — has also led to the high failure rate in neuroscience and deterred many large pharmaceutical companies from undertaking research in the field and prompted the exit of companies including Pfizer Inc., the biggest U.S. drugmaker by sales, earlier this year.

Success needed in neuroscience

"I've been around this area long enough to have heard the death knell of neuroscience many times and I would say that yes, some big companies exit," said Dolmetsch. "We need a success, for sure, and that will trigger more companies coming back into neuroscience. I mean, psychiatry has been particularly badly hit specifically because there is this sense that you need to have really giant trials, and it's very expensive and they are prone to failing."

The search for new and better targets for the wide range of psychiatric disorders that have often been lumped together into one diagnosis was boosted by the advent of genetic sequencing in the 1990s. Still, the expense of such sequencing was prohibitive until 2000.

"That [neuroscience] is one of the more challenging therapeutic areas, and why you've seen, over recent years, so many of the life sciences majors actually refocus on other therapeutic areas," said Pamela Spence, global life sciences industry leader at consulting firm EY, in an interview. "But I 100% agree that there's so much opportunity and I think also, as technology advances and as we can analyze data more specifically, we'll see a lot more frequent breakthroughs in some of these therapeutic areas that previously have proved more challenging than others."

Dolmetsch and his team at NIBR tackle their research by going back to human genetics, taking advantage of the fact that the cost of sequencing has gone down "about a million-fold" since the year 2000. They are trying to develop medicines based on human mutations so that when the drug enters the phases of human testing, the researchers already know whom to test it in: people with those mutations. Given Dolmetsch's background, collaboration with other academics is also high on their agenda.

"The problem of identifying key genetic variants is too large for any one company so there's no question it's going to have to be done as part of a collaborative effort," Dolmetsch said. "We are competing in the medicines that we make, not so much in the targets that we discover."

Changing the course of disease

Novartis' approach to schizophrenia is to try to develop so-called disease-modifying therapies that can be given to patients earlier in the course of their illness, perhaps after the first psychotic episode, or even before that. Disease-modifying drugs treat the underlying cause of the illness, rather than just interfering with the brain chemical dopamine, which is the method of action of current antipsychotic drugs first developed in the 1950s.

So-called second-generation antipsychotics developed in the 1990s, including AstraZeneca PLC's Seroquel and Eli Lilly and Co.'s Zyprexa, also known as olanzapine, have a plethora of unpleasant side effects ranging from heart and liver issues to diabetes and cholesterol problems, as well as neurological and movement disorders. The result is that adherence to medication is poor in many psychiatric patients.

In addition to working with Pear on measuring trial results on a day-to-day basis, Novartis is trying to make it easier for patients to be part of clinical trials. The drugmaker is collaborating with Science 37 Inc., a pioneering Los Angeles-based clinical trial company that monitors patients via smartphone assessment at a patient's home or local physician's office rather than at a central site.

Being able to predict who is going to have a psychotic episode may even prevent the development of the disorder, which would have the greatest impact of all, Dolmetsch said.

"The hope is we can collect better information and provide better care," he said. "We'll have to see how it works but I think it's potentially huge."