Developing an edible medical device to hinder the progression of diabetes
CEO: Sana Alajmovic
Based: Stockholm, Sweden
The scoop: It seems like a drug at first glance, but it’s not. Sigrid Therapeutics is developing a so-called therapeutic material: a fine, edible powder that interacts with the inner workings of the body mechanically, not biologically.
Blended with water and taken before each meal, just a few grams of the tasteless and odorless mix contain myriad micron-sized silica particles honeycombed with tiny pores. These gaps physically separate food particles from digestive enzymes throughout the gut—gently applying the brakes on the overall gastric process and blood sugar intake.
“Our goal is to become the world's first device approved for management of blood sugar levels in people with prediabetes,” says Sigrid co-founder and CEO Sana Alajmovic.
The engineered particles’ (relatively) large size means they can’t pass from the digestive system into the bloodstream and are instead eliminated from the body normally.
Late last year, the company reported the first results from its single-arm, proof-of-concept study in participants with prediabetes and newly diagnosed Type 2 diabetes.
The powder, dubbed SiPore15, demonstrated a 1.4 mmol/mol mean reduction in HbA1c after three months, along with no serious adverse safety events. This compares favorably to past studies of the mainstay diabetes drug metformin, the company says.
Sigrid also recently published a study using mice in the journal Nanomedicine, showing it can help prevent weight gain, an application the company hopes to explore in the future.
What makes Sigrid Therapeutics fierce: Silica powder is made from some of the most common elements on Earth. It forms the basis of major international industries, and it has been used as an anticaking food additive for decades as a material Generally Recognized as Safe by the FDA.
Still, the company has had to fight to find a willing supplier.
To secure enough for its research and development, Sigrid has had to claw some silica away from a global marketplace much more familiar with its applications in the construction industry or in the production of glass and microchips.
“They can produce on the ton scale if you want a hundred tons,” says Alajmovic. “But not many are interested in producing kilograms for a company with a novelty material in clinical trials.”
For its proof-of-concept study, the company had to reach out to over 75 international contract development and manufacturing organizations before finding one that was convinced by the potential of the technology, she says: “They do small molecules, and they do proteins, but they don't really do silica material chemistry.”
But now, Sigrid is gearing up for global markets and talking about ton-scale production. With in-human data in hand, “now they’re opening up their house to us,” Alajmovic says. “This is one of the largest silica companies in the world, and they’re telling us, ‘We've done silica for 100 years, and it has never occurred to us that this type of product could be applied to metabolic health in this fashion.’”
Over the next two years, the company hopes to acquire a CE mark for SiPore15 and establish a clear pathway to a device approval from the FDA.
In addition, Alajmovic says the powder can be developed as a platform—tweaked to different sizes to better target new enzymes and biomolecules—for use in other indications such as obesity, or potentially in children with Type 2 diabetes or prediabetes.