metaMe Health partners with Indegene to launch Regulora®, an FDA-cleared Prescription Digital Therapeutic for adults with Irritable Bowel Syndrome

PRINCETON, N.J. and CHICAGO, March 22, 2022 (GLOBE NEWSWIRE) — Indegene, a technology-led global healthcare solutions provider, and metaMe Health, Inc. (metaMe), a Prescription Digital Therapeutics (PDT) company and developer of Regulora^®, today announced a partnership to bring Regulora to market for the treatment of abdominal pain due to Irritable Bowel Syndrome (IBS).

IBS is a chronic condition that affects 10-15% of adults in the United States. The central symptom is abdominal pain, which is accompanied by diarrhea (IBS-D), constipation (IBS-C), or a mix of both (IBS-M). IBS has a severe impact on quality of life. According to a survey of nearly 2,000 patients, IBS sufferers say they would give 25% of their remaining life (an average of 15 years) to live symptom free.¹ The annual cost of IBS treatment in the United States has been estimated to be between $1.7 billion and $10 billion in direct costs, with total indirect costs of $20 billion.²

metaMe Health’s Regulora is the first FDA-authorized PDT specifically for abdominal pain associated with IBS in adults. It provides self-administered Gut-Directed Hypnotherapy (GDH) through a convenient iOS and Android app that can be used at home along with other IBS treatments. Until now, the availability of GDH has been limited, as it has been provided in person by specialized therapists. “Regulora now makes this treatment accessible to any adult with IBS through their doctor or GI specialist, and also makes it far more convenient because no therapist visits are needed to receive Regulora,” said Dr. Olafur Palsson, Professor of Medicine in the Division of Gastroenterology and Hepatology at the University of North Carolina.

Through a multi-year partnership, Indegene will work with metaMe Health to use its flexible and capital-efficient commercial model to educate healthcare providers, patients, and payers about the benefits of this innovative treatment. To help metaMe Health launch Regulora, Indegene brings deep healthcare expertise and advanced omnichannel capabilities powered by artificial intelligence and machine learning. Indegene’s unique Co-Commercialization model ensures that Regulora reaches the right patients while allowing metaMe to focus on its mission of developing innovative Prescription Digital Therapeutics.

Tim Rudolphi, CEO at metaMe Health, says, “We are excited to introduce Regulora as the first FDA-authorized treatment of its kind for IBS in adults. Indegene’s end-to-end commercialization process gives us confidence that this therapy will reach patients and improve their quality of life. It is great to have a partner like Indegene we can trust to manage the complexities of the process of taking our product to market.”

Nathan Piland, Vice President at Indegene, adds, “We are proud to enable metaMe Health’s mission to put the power to heal right in the hands of patients. With over 30 million symptomatic IBS patients in the U.S. alone, we have a great opportunity to make a difference using our digital-first omnichannel approach to bring Regulora to market quickly and at scale.”

Prescription Digital Therapeutics deliver evidence-based therapeutic interventions through high-quality software programs to prevent, manage, or treat a medical disorder or disease. PDTs incorporate advanced technology, best practices for design, clinical evaluation, usability studies, and data security, and are developed under the same rigorous conditions as pharmaceuticals – complete with clinical trials, FDA clearance, and availability through a physician’s prescription.³

PDTs will continue to be a key piece of the emerging global digital market. In recent years, more than $12.5 billion was invested in digital health start-ups. According to one estimate, the value of all digital health start-ups may reach $500 billion by 2025.⁴

About metaMe Health, Inc.
metaMe Health, Inc. (metaMe) is a U.S. company that develops Prescription Digital Therapeutics (PDT) for the treatment of common chronic conditions. metaMe’s initial digital solutions aim to relieve the pain and disruption of everyday life experienced by millions suffering from gastrointestinal disorders. By allowing patients to be prescribed treatment confidentially and to undergo treatment privately at home, metaMe offers non-drug options that provide relief in a familiar, comfortable environment. For additional information, please visit metamehealth.com or follow @metaMeHealth on Twitter and metaMe Health on LinkedIn.

About Indegene
Indegene is a technology-led healthcare solutions provider. It combines deep industry expertise with fit-for-purpose technology in an agile and scalable operating model. Many of the leading, global healthcare organizations rely on Indegene to deliver effective and efficient clinical, medical, and commercial outcomes every day. From strategy to execution, Indegene enables healthcare organizations be future ready. To learn more about how Indegene delivers on its purpose, please visit www.indegene.com

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References
1 Gastrointestinal Society IBS Global Impact Report 2018 –
https://badgut.org/wp-content/uploads/IBS-Global-Impact-Report.pdf
2 Hulisz, D., J Managed Care Pharm, 2004. PMID 15298528
3 Digital Therapeutics Alliance. Digital Therapeutics Definition and Core Principles Fact Sheet. Accessed January 11, 2022.
https://dtxalliance.org/wp-content/uploads/2021/01/DTA_DTx-Definition-and-Core-Principles.pdf
4 McCann C. Realizing the promise of prescription digital therapeutics. STAT. October 29, 2019. Accessed December 31,
2021. https://www.statnews.com/2019/10/29/prescription-digital-therapeutics-realizing-promise/