Aimmune Launches the First Real-World Registry Study for Patients with Chronic Pancreatitis

— The 400-patient observational registry study will provide deeper understanding into the unmet needs, therapeutic burden and overall patient experience for patients with EPI —

BRISBANE, Calif.--(BUSINESS WIRE)--Aimmune Therapeutics, a Nestlé Health Science company developing pharmaceutical therapies to prevent, manage and treat food and metabolic-related diseases, including exocrine pancreatic insufficiency (EPI), today announced the launch of PACT-CP, a Patient-Centric Chronic Pancreatitis Registry study to better understand the unmet needs and therapeutic burden on patients with EPI due to chronic pancreatitis (CP).

“One of the key elements in understanding human disease is to conduct carefully designed, prospective clinical studies in populations of patients that represent real-world risks, treatments and outcomes,” said David C Whitcomb, MD PhD, Giant Eagle Foundation Professor of Cancer Genetics and Director, UPMC Precision Medicine Service at the University of Pittsburgh and UPMC. “Studies such as PACT-CP will be invaluable in improving the understanding and treatment of complex disorders such as chronic pancreatitis."

The study was designed using input from patients and expert advisors and will track approximately 400 patients at 20 gastroenterology sites across the United States. Data will be collected both during regular office visits and through mobile-friendly direct-to-patient surveys with the goal of better understanding:

• Unmet needs and therapeutic burden
• Overall patient experience (symptoms, diet, quality of life and treatment satisfaction)
• Healthcare utilization outcomes in standard of care

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.¹ Up to 48% of patients with chronic pancreatitis develop EPI¹, a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in the inability to digest food properly, or maldigestion.² 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 secretory functions.³

“Aimmune is committed to further understanding the impact of EPI on the quality of patients’ lives with chronic pancreatitis,” said Andrew Oxtoby, President and Chief Executive Officer for Aimmune Therapeutics. “The PACT-CP Registry study will follow patients for up to five years and be an important source of real-world data that will characterize clinical and patient-reported outcomes, providing valuable insights to Aimmune and to the medical community.”

About the PACT-CP - Patient-Centric Chronic Pancreatitis Registry Study

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.

To find a study site near you, please email Sabrina Butler at sabrina.butler@healthivibe.com with your city, state and zip code.

About Aimmune

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. For more information, please visit www.aimmune.com.

About Nestlé Health Science

Nestlé Health Science (NHSc), a wholly owned subsidiary of Nestlé, is a globally recognized leader in the field of nutritional science. At NHSc we are committed to empowering healthier lives through nutrition for consumers, patients and their healthcare partners. We 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 is redefining the way we 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, for a healthier today and tomorrow. www.nestlehealthscience.com.

AIMMUNE^® and AIMMUNE THERAPEUTICS^® are trademarks of Aimmune Therapeutics, Inc.

1. JAMA. 2019 Dec 24;322(24):2422-2434.
2. Al-Kade S. Exocrine pancreatic insufficiency. Medscape website. http://emedicine.medscape.com/article/2121028-overview. Accessed April 2021
3. World J Gastroenterol. 2019 May 28; 25(20): 2430–2441.

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Lauren Barbiero
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lbarbiero@realchemistry.com