When Will There Be a Cure for Diabetes?
Diabetes doesn’t cause nearly as much of a stir in the media compared to HIV or cancer, but a few well-known names are associated with the disease – Halle Berry, Tom Hanks, and Paula Deen. And who doesn’t love that Food Network maven and American celebrity chef? Scandals aside, diabetes comes in two versions – Type I or Type II. In Type I, the pancreas decides to drop out of the physiological rat race and go on to discover its own metabolic purpose in life. As a result, the body generates little or no insulin, a hormone important in sugar metabolism. In Type II, unfortunate dietary choices, such as eating tons of sugar and carbohydrates, jam up the sugar absorption process, causing the body to become resistant to the insulin hormone. Type 2 makes up 90 percent of all cases of diabetes, which is going to be our focus here as we talk about when there will be a cure for diabetes. (Spoiler alert: Probably only after we ban the Big Gulp and the Big Mac.)
Diabetes and Insulin
Insulin is a type of hormone made up of 45 amino acids, and it is important for signaling to the body’s cells to pick up excess sugar from the bloodstream. Normally, whenever you decide to drown yourself in a Big Gulp from 7-Eleven, the sugars in the soda will be absorbed through your stomach directly into your bloodstream. Insulin is pumped out by the pancreas, which acts as a signal that gives the thumbs up to your muscles and fat cells to throw a sweet rager with the soda you just dumped into your body. Everyone has a good time – until the party ends.
Without insulin, that extra sugar starts to hang out in your blood with nowhere to go. Just like with honey or sweet syrup, high concentrations of sugar causes the blood to thicken. Physiologically, this pulls fluids and water from other parts of the body into the bloodstream, causing swelling and dryness. Early symptoms of diabetes are relatively mild, including excessive peeing, dry mouth, itchy skin, hunger, fatigue, and blurred vision.
A whole range of issues start to crop up when diabetes is left untreated. Excess sugar in the blood can lead to more persistent yeast infections (yeast love sugar). High blood sugar can also affect blood flow, which leads to slower healing for sores and wounds. Over time, the condition can lead to Peripheral Artery Disease (PAD), which causes blood vessels to narrow, lending to a condition called peripheral neuropathy that results in a person not feeling pain. And without a sense of pain after an injury or development of an ulcer, the patient may not realize the wound is progressing – amputation may even be required to save him or her from sepsis.
The Challenges of Diabetes
The first step to treating diabetes is testing to determine if a person has the condition in the first place. Routine screening of type 2 diabetes is recommended after the age of 45 by the American Diabetes Association, especially for overweight individuals. Those who are living a sedentary lifestyle or have complicating risks for cardiovascular disease or other metabolic diseases are more likely to be screened earlier. After determining if a patient has diabetes, a physician will usually recommend they undergo a lifestyle change towards healthy diet and exercise, but most people also require the help of diabetes medications and insulin therapy.
Yup, that’s the regular stuff. Credit: DietDoctor.com
Medications include a long (and boring) list of chemical names such as metformin, sulfonylureas, meglitinides, thiazolidinediones … you get the point. Each of these drugs works by either helping the body secrete more insulin, making tissues more sensitive to the hormone, or preventing the secretion of more sugar into the bloodstream. But, ultimately, the first line of defense against diabetes is direct insulin injection because of its high efficacy. And there are at least six main types of insulin, accompanied by another long list of difficult-to-pronounce suffixes, each with a slightly different effect. Along with treatment, diabetes requires constant monitoring for blood sugar levels, which include at-home blood tests, and routine medical check-ups. An insulin pump that monitors and injects insulin when needed is another option.
The bottom line is that treatment and management can become tedious, complicated, expensive, and painful for the average patient.
Scientists and researchers are skeptical about the possibility of a true cure for type 2 diabetes. Michael German, a professor at the University of California, San Francisco, believes much of the success in a diabetes cure depends on an individual’s genetic makeup. And the Joslin Diabetes Center, the world’s largest diabetes research center and an affiliate institute of Harvard Medical School, claims that there is no cure for diabetes. Regardless, everyone can agree that an effective cure could put an end to the cycle of suffering for diabetes patients.
Diabetes and Its Market Potential
Today, 425 million adults live with diabetes, and that number is expected to grow to 629 million by 2045, with the greatest number between the ages of 40 to 59 years old. The global prevalence of diabetes has risen from 4.7 percent in 1980 to 8.5 percent in 2014, with the proportion of type 2 diabetes increasing around the world. On top of those numbers, another whopping 352 million people are at risk of developing type 2 diabetes. According to the 2017 Economic Cost of Diabetes survey sponsored by the American Diabetes Association, the total cost of diabetes was estimated to be $327 billion, a 26 percent increase since 2012. About three-quarters of those costs are associated with direct medical expenditures. Patients with diabetes are expected to pay an average of $9,600 in additional medical costs annually. A diabetes cure could cut out a nice chunk of fat out of those costs, potentially worth $245 billion from the 30 million diabetic Americans alone.
Potential Cures of Diabetes in the Works
Below we highlight some of the types of cures and therapies being developed.
Founded in 2007, San Francisco startup NGM Biopharmaceuticals is a pharmaceutical company that has raised $295.4 million, with pharmaceutical giant Merck & Co., as one of its most recent investors. The company has just filed to sell $75 million of its common stock in an IPO. The company’s primary candidate for treating diabetes is NGM313, an engineered antibody that binds to a novel pathway that reduces insulin resistance. After the successful conclusion of a phase I on the drug, NGM plans to license the antibody to Merck.
Founded in 1999, San Diego-based ViaCyte has raised a total of $201.5 million in funding, with major investments from Johnson & Johnson and Bain Capital. ViaCyte is addressing diabetes by developing a technology based on converting stem cells into pancreatic tissue that can produce insulin, and implanting the new tissue into patients inside an immunoprotective device for continuous insulin production.
Recently, ViaCyte and CRISPR Therapeutics (CRSP) announced a strategic collaboration to produce gene-edited stem cells that can evade immune system recognition, reducing the incidence of host rejection and improving the transplantation process.
Founded in 2006, Massachusetts-based biotechnology startup Gelesis has raised a total of $118.2 million for developing an oral smart pill. In 2016, the company initially filed an IPO offering of $60 million, but pulled out and instead focused on raising more funding. The technology is based on capsules filled with tiny hydrogel particles that expand between 50 to 100 times their weight in size after absorbing water from the stomach, which results in increased satiety to help obese diabetes patients lose weight and control their sugar metabolism. They are currently undergoing a phase 2 clinical trial on their Gelesis200 product for treating diabetes.
Update 12/10/19: Gelesis has raised $63.4 million in new equity funding as they prepare for large-scale commercial availability of Plenity in the U.S. This brings the company’s total funding to $212.8 million to date.
Nutritional Clinical Therapy
Founded in 2014, San Francisco-based startup Virta has raised $82 million after a recent Series B round led by Venrock, a venture capital firm with ties to the Rockefeller fortune. The company is an online medical clinic that applies nutritional biochemistry to reverse type 2 diabetes. The company provides a starter kit, coaching, and physician check-ups online through a subscription fee-model to give patients access to the tools to treat and monitor their diabetes.
Virta relies on a clinically proven treatment based on medically inducing ketosis, a metabolic condition that occurs when the body is starved of sugars and instead relies on fats for energy.
Update 01/10/20: Virta Health has raised $93 million in Series C funding to scale the business to many more patients. This brings the company’s total funding to $175 million to date.
Converting Liver Cells
Maryland company Orgenesis (ORGS) is developing a proprietary therapeutic platform that transforms adult liver cells into insulin-generating cells to provide patients with independent insulin production. Earlier this year, Orgenesis entered into a partnership with HekaBio K.K. to conduct clinical trials in Japan. The company appears to be moving into licensing the technology to other companies for further development.
Poxel (PP:POXEL) is a French pharmaceutical company that recently received $30.1 million in post-IPO equity in 2016. The company has developed an orally active medication called Imeglimin, which targets all three organs and body systems that are affected by diabetes simultaneously: the pancreas, liver, and muscles. The drug is currently undergoing phase 3 clinical work in Japan, and will commence phase 3 trials in the European Union and the United States that will be completed by 2019. The company is also concurrently working on several other pharmaceutical agents in various stages of the development pipeline.
Another French company, Valbiotis (FP:ALVAL), has developed the plant-based VALEDIA to reduce the risk of type 2 diabetes by treating patients with pre-diabetic symptoms. The product is based on the active ingredient TOTUM-63, a combination of five plant extracts that work synergistically to address several metabolic factors that play a role in diabetes development.
Valbiotis recently entered into phase IIB1 clinical trials in the United States on 150 pre-diabetic patients to determine the most effective dose for VALEDIA.
While scientific controversy still exists over whether a cure for diabetes even exists, the possibility is still bright with current advances in technology. Cutting-edge technologies like stem cells therapies and regenerative medicine are pushing the envelope, and may hold high promise for a potential cure to diabetes, but there’s also still room for advanced oral-based pharmaceuticals to help in the battle against diabetes. Chronic diseases such as type 2 diabetes can certainly draw big investments, something we see not just from the above companies but from a well-funded startup called Intarcia Therapeutics that we covered a few years ago when it had raised $759 million. It has now taken in $1.6 billion and is STILL in stage 3 clinical trials more than three years later. In other words, you need more than bright ideas to cure diabetes, but a lot of money to bring these therapies to market.