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Proteus Digital Health is collaborating on a pipeline of digital, oral solid-dosage drugs for various therapies, including cardiovascular and oncology drugs, based on its first NDA, which used ingestible sensors in an antipsychotic treatment.
Proteus Digital Health has created an ingestible sensor that enables a “new category of pharmaceuticals: digital medicine,” said Nik Leist, senior director of Ingestible Sensor Manufacturing and site leader for Proteus Digital Health, in a keynote address at CPhI North America on April 25, 2018. The sensor is an approved medical device composed of a silicon chip coated with minerals that are already part of the human diet.
The company has developed an efficient way to manufacture the sensors, as well as a process-based on existing solid-dosage manufacturing technology-for inserting them into a drug tablet or capsule to create a digital-medicine combination drug product, explained Leist.
Now, Proteus and business partners are working to extend the use of this technology to develop treatments in a number of important therapeutic areas.
After a patient ingests a digital pill, the sensor sends a signal to a patch worn by the patient, which communicates data to a mobile app, from which the patient and healthcare providers receive feedback. In addition to improving patient compliance, the data can be useful in documenting improved patient outcomes (important for physician reimbursement) and for demonstrating treatment effectiveness, which would make it possible for manufacturers to develop value-based contracts with payers.
In November 2017, FDA approved Otsuka Pharmaceutical’s Abilify MyCite (aripiprazole tablets with sensor),an antipsychotic drug that contains Proteus’ sensor. In addition, Proteus announced in an April 25, 2018 press release that, together with its collaborators, it has developed a pipeline of 31 digital medicines for mental health, cardiovascular and metabolic conditions, infectious diseases, and oncology.
“Our extensive clinical trial and commercial experience with digital medicines with thousands of patients has been overwhelmingly positive,” said Andrew Thompson, CEO of Proteus, in a press release. “The products are well accepted by consumers, secure, private, fully HIPAA compliant, and extraordinarily safe. More importantly, we have shown consistently that patients who choose to use DigiMeds take them about 90% of the time, compared to medication possession of 50% with regular drugs. Physicians coach patients and properly titrate medicines at three times the rate when they have accurate data on drug use and activities of daily life that our solutions provide.”
Proper use of medicines is especially important in the treatment of mental health, where patients can be hospitalized if they do not consistently use their drugs in the right dose. Proteus is working with Otsuka Pharmaceutical Company to develop digital medicines for the treatment of bipolar, schizophrenia and major depressive disorder. In addition to the approved Ablify MyCite, Proteus and Otsuka are investigating the development of additional digital medicine products in mental health where there is the greatest patient need and assessing opportunities for regulatory registration.
In cardiovascular and metabolic conditions, Proteus has a panel of 15 digital medicines that can be prescribed to named patients in the United States, prepared and delivered via specialty pharmacy services. Health systems in the US have entered into master service agreements to use the digital medicines, focusing on high-risk patients who are failing drug therapy. Proteus has conducted several clinical studies demonstrating the clinical and economic benefits of using digital medicines to improve outcomes in these patients, including a successful randomized control trial in patients with uncontrolled hypertension and type 2 diabetes (J Med Internet Res 2017;19(7):e246).
In infectious disease, the company has seven digital medicines that are being used in clinical studies to treat patients with TB, hepatitis C and HIV. These programs are designed to demonstrate that digital medicines effectively support expanded access to curative or life-sustaining drug therapies, ensuring excellent medication adherence with high levels of patient autonomy and satisfaction. UC San Diego TB researcher, Dr. Sara Browne, recently completed a randomized control trial comparing digital medicines-enabled Wirelessly Observed Therapy (WOT) to Directly Observed Therapy (DOT), finding that WOT detected 54% more doses than DOT while freeing patients from onerous direct observation requirements.
Proteus is developing a portfolio of digital medicines to help cancer patients. These DigiMeds include oral oncology agents that require complex dosing, as well as drugs intended to help alleviate side effects, including opioid analgesics. An advisor in this initiative is Dr. Linda Sutton, an Associate Professor of Medicine at the Duke University School of Medicine.
“Proteus technology has the potential to improve the quality of cancer care and make the work of cancer treatment teams timelier, more precise and more effective,” said Dr. Sutton, in the press release. “The explosion of therapeutic options with new drugs, as well as new molecular and genetic tests, has made oncology care increasingly complicated. We need the ability to support patient use of drugs in the right dose, on the right schedule, and ensure that these powerful medications are working as intended. There is so much uncertainty when prescribing oral oncolytics today. We send patients out of the clinic with prescriptions to fill and take at home, and oncology teams are challenged to guide patients through their treatment remotely. With digital oral chemotherapy drugs, the patient’s oncologist will know with certainty when the patient took his or her chemo. That puts the oncologist in a better position to determine if subsequent problems are related to disease progression or drug toxicity, and better able to assess drug efficacy.”
Sources: Proteus Digital Health, CPhI North America keynote address