Mahana Therapeutics has secured $61 million Series B financing to launch the FDA-cleared prescription digital therapeutic for irritable bowel syndrome (IBS), Mahana™ IBS. The funding will also help to accelerate the pipeline development of digital therapeutics for other chronic conditions. JAZZ Venture Partners* and Gurnet Point Capital led the financing with significant support from new and existing investors Main Street Advisors, Lux Capital*, and KKCG. Mahana™ IBS is the first accessible, affordable, and effective FDA-cleared prescription digital therapeutic for irritable bowel syndrome, according to the announcement.
*led the company’s prior rounds.*
IBS Overview
Irritable bowel syndrome (IBS) is a common disorder that affects the large intestine. Only a small number of people with IBS have severe signs and symptoms. Some people can control their symptoms by managing diet, lifestyle, and stress. More severe symptoms may require medication and counseling.
According to Mahana Therapeutics’ announcement, IBS is commonly treated with pharmaceutical interventions, which have been shown to reduce symptom severity. However, many patients are disappointed with continued challenges in treating and managing their IBS and are not satisfied with their current treatment. A recent review of IBS therapies suggests cognitive behavioral therapy (CBT) may be among the most effective available treatments for the condition. While this is great, most of the 35 million individuals diagnosed with IBS in the United States do not have access to licensed clinicians trained in CBT for GI conditions, and therefore were unable to receive CBT treatment before the availability of Mahana IBS.
What is a Digital Therapeutic?
Digital therapeutics (DTx) deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders. Products are held to the same standards of evidence and regulatory oversight as traditional medical treatments. DTx’s are typically used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes. These digital therapies empower patients, clinicians, and payers with intelligent and accessible tools for addressing a wide range of conditions through high-quality, safe, and effective data-driven interventions.
What is Mahana Therapeutics Mahana™ IBS?
Being a digital therapeutic, Mahana™ IBS is an FDA-cleared, prescription mobile application that delivers lasting symptom relief through clinically validated cognitive-behavioral therapy (CBT). The digital therapeutic is designed to help people build healthier brain-gut relationships, decrease symptom severity, and increase overall well-being. Throughout the three-month program, patients will learn how to track symptoms, manage flare-ups, change unhelpful behaviors and thoughts, and build personalized techniques for lasting relief. Mahana for IBS has no known side effects, and it is intended to be used together with other IBS treatments.
We are grateful for the support of leading digital health, technology, and life science investors who share our vision to empower patients with affordable, accessible, and effective digital tools to help patients manage their chronic conditions. We are fortunate at Mahana to have an extraordinary, dedicated team committed to serving patients with chronic disease. We sincerely thank the patients, clinicians and advisors who guide our development efforts and make our therapies possible.
Steven Basta, chief executive officer at Mahana Therapeutics
How Does Mahana™ IBS Work?
Mahana Therapeutics DTx is a prescribed mobile application accessible on an iPhone or Android device. Once downloaded, Mahana™ IBS teaches CBT skills that are practiced outside of the app and a toolkit to support your daily lesson content. The program consists of 10 sessions and multiple lessons within each session. Patients are encouraged to use the DTx once a day to achieve optimal results.
How Effective is Mahana™ IBS?
According to the products web page, Mahana™ IBS is an effective digital treatment program with one year or longer results. In clinical studies:
- Patients reported improved bowel function satisfaction and improved quality of life.
- Shown to reduce abdominal pain associated with IBS.
- Patients experienced, on average, fewer days with pain related to their IBS.
- Patients reported a clinically significant reduction in bloating severity associated with IBS.
Summary of Clinical Testing: Mahana IBS has been studied in a randomized, controlled trial in 558 patients with IBS. Patients with mild to severe IBS (IBS-Symptom Severity Scale [IBSSSS] ≥75) were randomly assigned to one of three treatment groups: Treatment-as-Usual (TAU), Therapist-delivered Cognitive Behavioral Therapy (TCBT) via telephone, or Web-based CBT (Mahana IBS). At Month three, group mean changes in IBS-SSS scores were reduced in the Mahana IBS group vs. TAU, and met the minimum clinically significant difference (MCID) of 50 points as defined for the IBS-SSS by Francis et al. The frequency of related, treatment-emergent adverse events (TRAEs) revealed no notable differences between treatment groups. The full clinical study summary is also available in publication.
The Future of IBS Treatments with Mahana Therapeutics
Healthcare in America is on the outset of great transformation, prompted by disruptive new technologies, regulatory demand and increasingly assertive, value-sensitive consumers. Reimbursement is a key determinant in the application of clinical interventions. More than 1 billion people worldwide suffer from chronic health conditions that can be treated or managed with cognitive or behavioral therapy. Mahana IBS is available by prescription only and is intended to provide three months (90 days) of cognitive behavioral therapy for adult patients aged 22 years and older with IBS.
Mahana Therapeutics has raised $81 million to develop and commercialize its digital therapeutics pipeline with this investment. Sophie Kornowski of Gurnet Point and Meghan Reynolds of JAZZ have joined the Mahana Therapeutics Board of Directors.
About Mahana Therapeutics
Mahana Therapeutics mission is to provide empowering treatments to patients living with chronic disease that teach them how to reduce their symptom severity and improve their lives. The Company’s first product, Mahana IBS, is the first digital therapeutic to receive FDA clearance for the treatment of IBS and provides cognitive behavioral therapy (CBT) to adults with IBS.
