2018 NEVYs Spotlight Series: Fractyl Laboratories, Inc.

The NEVCA is proud to share the stories of our 2018 NEVY Awards nominees through their own words. Hear their experiences of success, failure, and everything in between — most importantly, what has driven them forward to build and grow their vision, starting with the very first spark of inspiration.

By: Harith Rajagopalan, CEO & Co-founder, Fractyl Laboratories, Inc.

As a Cardiologist, I Was Frustrated with Ineffective Treatment Options for Type 2 Diabetes

Prior to founding Fractyl in 2011, I was a cardiologist who saw firsthand the day-to-day challenges type 2 diabetes presented for my patients and their family members. While worrying about potential heart attacks and strokes from their disease, patients also face a bewildering set of daily decisions related to managing their diets, blood sugars, and medications.

This frustration led me to seek out a better way to treat and manage type 2 diabetes. I found groundbreaking scientific discoveries that challenged the conventional wisdom regarding the root cause of this disease and pointed to the critical role of the gut in driving diabetes.

The Type 2 Diabetes Epidemic Escalates Despite Advances in Drug Therapies

Type 2 diabetes is an epidemic of staggering proportions and already represents the leading cause of adult blindness, kidney failure, and amputations in the United States. Unfortunately, the status quo for treating type 2 diabetes (T2D) is failing to stem the tide, even as the problem itself is worsening. In the past 25 years, more than 50 new drugs have been approved to manage the elevated blood sugars seen in T2D patients, yet outcomes for patients have worsened over the same period.

Bariatric Surgery Successes Point to Role of Gut in Type 2 Diabetes

My search revealed a remarkable observation that certain bariatric surgeries on the intestine, like gastric bypass, almost instantly reverse diabetes. Even more surprising is this effect is seen before any weight loss and without touching the pancreas. The amazing, and unexpected, outcomes from these surgeries made me wonder, “Have we have been treating the wrong problem in the wrong organ?”

There are two main types of diabetes. Type 1 is caused by the failure of the pancreas to make insulin, while type 2 is caused by the failure of the body to respond to the pancreas’ insulin. The drugs for type 2 diabetes attempt to improve the body’s response to insulin. When that approach fails, T2D patients supplement with extra insulin.

So, while there are an increasing number of drugs for type 2 diabetes, these have little impact on improving the patient’s disease state and afflict a significant treatment burden on the patient. That’s why the observation that gastric bypass surgeries can reverse diabetes is so interesting. It points to the role of the gut in type 2 diabetes, specifically a portion of the gut called the small intestine, where the majority of nutrients are absorbed by the body.

In fact, recent discoveries in metabolic science show that diet-induced changes to the lining of the first segment of the small intestine (the duodenum) can lead to insulin resistance and are associated with metabolic disorders such as type 2 diabetes and nonalcoholic steatohepatitis (NASH), a severe form of fatty liver disease. And that’s where Fractyl comes in.

There Must Be a Better Way

After a deep dive and due diligence, I was completely convinced that there is a better way to treat type 2 diabetes. Working with my co-founder, Jay Caplan, we developed a minimally invasive, therapeutic device-based procedure designed to rejuvenate the duodenum and restore the body’s ability to respond to insulin. Much as lasers rejuvenate the skin, Fractyl’s therapeutic procedure, called Revita DMR, is designed to rejuvenate the small intestine to reverse insulin resistance in type 2 diabetes and other metabolic diseases.

Revita DMR is a same day, outpatient procedure that not only is patient-friendly but also scalable, which is an absolute requirement if we are to reign in the diabetes epidemic. The clinical data we have collected to-date suggests that our approach is safe and may provide significant, durable, and sustained improvements in blood sugar and weight out to at least 12 months after a single procedure.

We believe Revita DMR is a paradigm shift in treating this growing epidemic. By targeting the underlying root cause of type 2 diabetes and other metabolic diseases, we believe can do better for the 500 million T2D patients around the world struggling to manage their diabetes while worrying about what that means for their long-term health.

What’s Next for Fractyl?

The idea that the intestines are linked to T2D was considered radical and unorthodox only a few years ago. As the scientific evidence has mounted, this link has become mainstream to our understanding of the disease, in part because of the work we’ve done here at Fractyl. We believe that our ongoing and planned clinical trials will build further support for the safety and efficacy of the Revita DMR procedure as a valuable option for patients suffering from type 2 diabetes.

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Every nominee is a winner in our eyes, but be sure to nab your NEVYs tickets now — and bring your teamto see who takes home the ultimate prize.

NEVY Awards on May 9th at the House of Blues Boston

Fractyl Laboratories, Inc.’s Website: http://www.fractyl.com
Follow Fractal Laboratories, Inc. on Twitter: @FractylLabs

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