There’s no shortage of unpleasant surprises in medicine, but every now and then the die roll in humanity’s favor. One recent example: bariatric surgery.
Originally designed for weight loss, experts found gastric bypass procedures unexpectedly resolved Type 2 diabetes in a subset of patients, pointing to a potential treatment for the underlying disease, not just the symptoms.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Fractyl Laboratories was founded in 2010 to take that discovery and run with it. On Thursday, the Lexington, Massachusetts-based company announced it had raised $44 Million in new equity financing. The Series D was led by an undisclosed first-time Fractyl investor, with GV (formerly Google Ventures), True Ventures, and the IDO Fund, joining an established syndicate from previous rounds.
In a phone interview, Fractyl Co-founder and CEO Harith Rajagopalan said the funding will help advance the company’s Revita DMR technology; a “minimally invasive procedural therapy” that seeks to mimic the metabolic effects of weight loss surgery. The catch? Science is still untangling the precise mechanisms at play.
“You have the bariatric surgery that doesn’t touch the pancreas; that is reversing diabetes before people even lose an ounce of weight,” Rajagopalan said. “[It] forces you to say ‘what the heck is going on in the intestine that we’re missing?’”
Targeting the root cause
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Bariatric surgery encompasses a variety of techniques that shrink the patient’s stomach and/or bypass sections of the stomach and small intestine to drive long-term weight loss. This, in turn, can help the patient prevent or manage various chronic conditions, such as Type 2 diabetes and non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH).
However, as NIH Director Francis Collins noted in his blog, patients often do well irrespective of the weight loss.
“One of the most intriguing consequences of the surgery is that patients’ blood sugar levels normalize within days—long before any weight loss has occurred. Patients can often stop taking their diabetes medication even before leaving the hospital,” Collins noted.
Scientists have spent many years trying to identify the underlying mechanism. Fractyl has too, balancing basic research while the development of its procedural platform. To make it more manageable, the company has focused its research efforts on the role of insulin resistance in Type 2 diabetes and, to a lesser extent, NAFLD/NASH.
According to the CDC, around 1.7 million new cases of diabetes are diagnosed in the U.S. each year. If this trajectory continues, as many as one out of every three adult Americans could have diabetes by 2050. Meanwhile, the market for NASH is expected to swell forty-fold over the next 10 years, from $618 million in 2016 to $25.3 billion in 2026.
Fractyl has designed an endoscopic catheter-based procedure that recreates the benefits of gastric bypass surgeries by making targeted changes to the duodenum — the uppermost part of the small intestine. A heated-balloon is used to modulate the intestinal lining while leaving the structure intact. Once completed, patients can often check-out of the hospital the same day.
In Type 2 diabetes, the cells in the body don’t adequately respond to the insulin produced by the pancreas, causing blood sugar levels to rise. Over 50 drugs are now approved to help manage the condition, often by introducing more synthetic insulin. If Fractyl can capture the effects of bariatric surgery, it could actually re-sensitize the patient so their natural insulin levels are appropriate.
Based on follow-up data on from patients in an earlier trial, the procedure appears safe and the benefits durable — for now, according to Rajagopalan. Fractyl is currently recruiting for a new randomized, double-blinded, sham-controlled study in Europe.
Rajagopalan is conservative when he talks about the technology: It’s not a panacea for the growing population of patients with Type 2 diabetes and NAFLD/NASH. But he does believe it could benefit a lot of patients. At the same time, the knowledge that Fractyl and other scientists are generating could help the field develop many more therapeutics in this space.
“I tell people that gastric bypasses are like our generation’s penicillin,” Rajagopalan said, referring to the serendipitous discovery of the first-ever antibiotic in 1928.
Both are accidental discoveries that shift the focus of the field, from managing symptoms to addressing the root cause of the disease or infection, he explained. For its part, penicillin sparked a whole new field of antibiotics and decades of innovation in treating infectious diseases. Rajagopalan hopes gut interventions can do the same for the 21st Century’s plague: metabolic diseases.
At least one other company, GI Dynamics, is looking to translate the metabolic benefits of bariatric surgery — though it had a major setback in November when its CE Certificate of Conformity was revoked.
Fractyl has a lot of work to do to gain market approval, but Rajagopalan said more and more people are becoming aware of the approach and are tracking the company’s progress. If it succeeds, the next major tool in the fight against Type 2 diabetes and NAFLD/NASH could be a device, not a drug. Sometimes medicine surprises us.
