A subsidiary company of Nestle Health Science recently announced the launch of a Patient-Centric Chronic Pancreatitis Registry (PACT-CP) study to better understand the unmet needs and therapeutic burden on patients with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP). Importantly, this carefully designed, prospective clinical program will track approximately 400 patients at 20 gastroenterology sites across America. Developed by Aimmune Therapeutics, the registry will be used to capture data during regular office visits via modern, mobile-friendly direct-to-patient surveys with the goal of better understanding the following: 1) unmet needs and therapeutic burden, 2) overall patient experience (e.g. diet, quality of life and treatment satisfaction), and 3) healthcare utilization outcomes in a standard case. The company’s building the first real-world CP registry with CorEvitas, which currently is a leading technology used in real-world registry studies.
What is Pancreatitis?
Chronic pancreatitis is a chronic inflammatory and fibrotic disease of the pancreas with a prevalence of 42 to 73 per 100,000 adults in the United States. Up to 48% of patients with chronic pancreatitis develop EPI, a condition characterized by a deficiency of the exocrine pancreatic enzymes, resulting in the inability to digest food properly, or maldigestion. Impaired food digestion in patients with CP and EPI can result in nutrient malabsorption and malnutrition, as well as disturbed regulation of gastrointestinal (GI) motor and secretary functions.
The PACT-CP Registry study is a prospective, non-interventional research study for individuals diagnosed with EPI due to CP under the care of a gastroenterologist. Approximately 20 clinical gastroenterology practices in the United States will be contracted to participate to collect healthcare information on people with EPI due to CP. Those who participate in the study will be patients prescribed an EPI therapy who will complete questionnaires 4 times a year for up to 5 years. Their gastroenterologists will provide information about their health, treatments, and symptoms. By collecting key information about the participants, including demographics, medical history (including all prior and current treatments for EPI), social history and details about their EPI condition, the registry study will generate critical data about the burden of EPI due to CP and provide important insights about current unmet needs in the lives of these patients.
Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing pharmaceutical therapies to prevent, manage and treat food and metabolic-related diseases, including exocrine pancreatic insufficiency. Aimmune markets a pancreatic enzyme replacement therapy (PERT), an FDA- and EU-approved medicine for peanut allergy and other investigational therapies in development.
Nestlé Health Science Company is a wholly owned subsidiary of Nestlé, is a globally recognized leader in the field of nutritional science. At NHSc, they position themselves to emphasize empowering healthier lives through nutrition for consumers, patients, and their healthcare partners. They describe that they offer an extensive consumer health portfolio of industry-leading medical nutrition, consumer and vitamins, minerals, and supplements (VMS) brands that are science-based solutions covering all facets of health from prevention, to maintenance, all the way through to treatment. NHSc, they position, is redefining the way they approach the management of health in several key areas such as pediatric health, allergy, acute care, oncology, metabolic health, healthy aging, gastrointestinal health, and inborn errors of metabolism. Headquartered in Switzerland, NHSc employs over 5,000 people around the world who are committed to making a difference in people’s lives around the world.
Partnership with CorEvitas
The company partnered with HealthiVibe, a subsidiary of CorEvitas, for the development of the registry study. Founded in 2000 and based in the Boston area, CorEvitas provides real-world evidence via syndicated registry data and analytics, patient experience and insight, as well as EMR and claims data in the UK. The company works with pharmaceutical companies, helping them demonstrate the significant value and differentiation of their products to clinicians, patients, payers, and regulators.
To date, they report on LinkedIn that they operate eight primary autoimmune registries across America, Canada, and Japan, collecting data from over 400 investigator sites. They tout the level of data evidence associated with their technology, noting that the registry’s been used in observational research across therapeutic areas contributing to over 140 peer-reviewed manuscripts and 430 abstracts. The company positions that its technology has conducted active safety surveillance to support regulatory commitments for14 new drug approvals, such as formal post-authorization safety studies.
Contract Registry Organization
The PACT-CP study will be managed by a division of Aimmune Therapeutics called HealthiVibe, which offers a systematic, evidence-based process for companies to engage the patient at every stage of the pharmaceutical project lifecycle; from clinical trial design through post-approval activities and research. We offer full-service patient initiatives, with a focus on patient insights and communication, to help biopharmaceutical companies create more patient-centered programs.