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With $35M, Whole Biome Eyes 2020 Launch of Medical Food for Diabetes

Xconomy San Francisco — 

Diabetes treatments available today include shots and pills intended to restore the hormone balance that leads to healthy blood sugar levels. Whole Biome aims to accomplish the same thing—but with a capsule that targets the gut microbiome.

Whole Biome is preparing to launch its product early next year. To support those plans, the San Francisco-based startup has closed $35 million in Series B funding, led by Sequoia Capital.

Whole Biome’s work builds on the growing body of research revealing the role that the gut microbiome plays in human health. Microbes that play an important role in diabetes include bacteria that metabolize dietary fiber into short-chain fatty acids, according to research published last year in Medical Sciences. This process helps the body produce the hormones that control blood sugar.

But people who have type 2 diabetes lack these gut bacteria, the research shows. Eating more fiber doesn’t help these patients if they can’t metabolize it, says Colleen Cutcliffe, co-founder and CEO of Whole Biome. Cutcliffe (pictured above) says her company’s goal is to restore the microbes diabetics are missing.

“None of us is genetically encoded to do that metabolism,” she says. “It’s entirely done by your gut microbiome.”

The Whole Biome product is a capsule containing microbes, as well as probiotics that feed them. The bacterial strains are naturally occurring organisms, and Whole Biome does not engineer them in any way, Cutcliffe says.

Whole Biome developed its product by using computational software to map the gut microbiome and identify the function of particular microbes. By comparing the gut microbiome of a healthy person to that of someone who has a metabolic disorder, Cutcliffe says her company was able to identify the bacteria that diabetics lack.

Whole Biome is one of a growing number of companies researching ways to targeting the gut microbiome to treat disease. Cambridge, MA-based Seres Therapeutics (NASDAQ: MCRB) is developing microbial formulations to treat gut disorders, such as Clostridium difficile infection and ulcerative colitis. Another Cambridge microbiome company, Vedanta Biosciences, is also developing treatments for C. diff infection, as well as inflammatory bowel disease.

Those companies have raised more money, but Whole Biome is on track to reach the market before any of its microbiome peers. Seres, Vedanta, and other microbiome companies are developing therapeutic products. Whole Biome’s yet-to-be-named product is a medical food, an FDA classification that falls between the strict regulatory review of pharmaceuticals and the comparatively looser oversight of dietary supplements.

Medical foods are products used for dietary management of a disease. These products don’t have active pharmaceutical ingredients. Instead, a medical food’s ingredients must be what the FDA considers “generally recognized as safe.” Cutcliffe says that because the microbes that Whole Biome uses are naturally occurring and found in abundance in healthy people, they are safe for use in the company’s type 2 diabetes product.

The microbes Whole Biome uses come from healthy humans, and they’re multiplied in the company’s labs. Whole Biome manufactures its medical food product in its own facility according to the quality control and manufacturing standards enforced by the FDA.

Unlike experimental drugs, medical foods don’t go through three phases of clinical testing. But Whole Biome does have clinical data from about 100 type 2 diabetes patients. In the double-blinded, placebo-controlled study, Whole Biome says patients given the company’s medical food saw reductions in hemoglobin A1C, a key measure of blood sugar levels. The company adds that its medical food reduced blood glucose spikes without any side effects related to the product. The company is preparing to publish the data, which will be formally presented next month during the American Diabetes Association Scientific Sessions gathering in San Francisco.

The patients enrolled in the Whole Biome study were already being treated with metformin, a first-line diabetes drug commonly prescribed for the disease. Medical foods don’t require prescriptions, but the FDA requires that they be taken under a physician’s supervision. Cutcliffe says she envisions her company’s product becoming part of a patient’s broader strategy for diabetes management.

Cutcliffe says Whole Biome will use the new capital to commercialize its type 2 diabetes product. The company also plans additional clinical trials to determine which patients will benefit most and also to find the optimal dose (in clinical trials, patients were given one capsule in the morning and a second one at night). Cutcliffe says Whole Biome will use digital marketing to sell directly to consumers. The product’s price has not yet been determined.

Whole Biome will also use the cash to continue its research on medical foods for other diseases. The company is working with Johns Hopkins University on a product for irritable bowel syndrome, taking the same approach that led to the diabetes capsule.

“The goal is to use this approach and apply it to multiple diseases where there is evidence it could have efficacy for patients,” Cutcliffe says.

Since it was founded in 2013, Whole Biome says it has raised $57 million. The latest financing included earlier investors True Ventures, Khosla Ventures, Mayo Foundation, and AME Cloud Ventures.

Photo by Whole Biome