Sigrid Therapeutics Secures U.S. Patent for Glucose Management Tech

Swedish healthtech firm Sigrid Therapeutics has been granted a U.S. patent for its SiPore platform technology. As an effective method of lowering blood glucose, SiPore promises to become an alternative treatment to reduce the risk of developing metabolic syndrome, type 2 diabetes, insulin resistance, or hyperglycaemia.

Patent 12,121,612, “Porous silica material for use as a pharmaceutical or dietary active ingredient,” supports the use of Sigrid’s mesoporous SiPore silica particles—i.e., precisely engineered micron-sized silica particles with tailored porosity—for lowering blood glucose levels. The patent also supports using mesoporous SiPore silica particles for treating or reducing the risk of developing metabolic syndrome, type-2 diabetes, insulin resistance, or hyperglycaemia.

“The granting of this patent significantly strengthens Sigrid’s global IP portfolio and highlights the versatility of our SiPore technology in addressing critical metabolic health challenges,” said Ghislaine Robert-Nicoud, head of Product Development at Sigrid Therapeutics. “The recognition of our product’s potential by the USPTO further validates our expertise in developing silica-based biomaterials for managing blood glucose and reducing the risks of diabetes and related conditions. This milestone enhances the commercial appeal of SiPore in one of the most important global markets. It comes as we finalize our SHINE clinical trial in people with elevated blood glucose levels who are living with obesity or excess weight, with results expected in QI 2025.”

Sigrid’s lead product candidate, SiPore 21, is an orally administered solution deemed a Class IIB medical device in the European Union and a medical food in the United States. Designed to safely reduce blood sugar levels in individuals at risk of diabetes and newly diagnosed type-2 diabetics, SiPore 21 is a pleasant-tasting gel consumed with meals. Composed of precisely engineered micron-sized silica particles with tailored porosity, it acts locally in the gut, ensuring effective blood sugar management without any systemic absorption.

“Our vision with SiPore 21 is to transform blood sugar control by delivering an accessible and effective solution that enables millions of individuals worldwide to take charge of their metabolic health,” Sigrid Therapeutics Co-Founder/CEO Sana Alajmovic said. “This new patent further solidifies our competitive edge as we advance discussions with leading global consumer healthcare companies and top-performing regional distributors, who have shown strong interest in partnering with us upon achieving regulatory approvals.”

In 2021, the European Patent Office (EPO) similarly granted the company a patent for the use of porous SiPore silica particles as pharmaceutical or dietary active ingredients. The European patent is validated in key markets including the EU, United Kingdom, Switzerland, Norway, Iceland, and Turkey. 

SiPore mesoporous silica particles (MSPs) are an ingestible material engineered with a vast surface area and customizable pore sizes. These particles work by physically interacting with digestive enzymes, reducing the breakdown of food and limiting energy absorption. Taken with meals, SiPore particles works locally in the digestive tract, where enzymes break down food, allowing nutrients to be absorbed. The SiPore particles have specially designed pores that are large enough to capture digestive enzymes but too small for undigested food particles. This unique design effectively separates these enzymes from the food, slowing the breakdown of carbohydrates and fats and leading to a reduced intake of energy. By moderating this process, SiPore particles help improve blood sugar control, as seen in lower HbA1c levels over time. Preclinical studies published in Nanomedicine^1,2 have shown promising results, with MSPs reducing food efficiency by 33%, leading to a healthier metabolic profile. Key outcomes include significantly reduced adipose tissue formation, lower circulating insulin levels, and decreased leptin, all of which contributed to a substantial reduction in weight gain. Additional research in Advanced Healthcare Materials³ further confirmed that MSPs effectively trap enzymes, such as amylase and lipase, within their porous structure. This enzyme-blocking action reduces the breakdown of carbohydrates and fats, as demonstrated by in vivo studies, where MSPs mixed with milk resulted in reduced lipid absorption.⁴ MSPs address metabolic disorders by targeting nutrient absorption directly in the gut.

Sigrid Therapeutics is a clinical-stage healthtech company committed to improving the management and prevention of metabolic diseases, including type-2 diabetes. Its breakthrough technology platform, SiPore, is the foundation of its lead product, SiPore 21—an orally administered medical device designed to improve metabolic function. Supported by robust clinical data, the SiPore technology demonstrates significant benefits across a range of metabolic markers while maintaining an excellent safety profile.^3,5-7

References
¹ Large pore mesoporous silica induced weight loss in obese mice, Nanomedicine, 2014, https://www.futuremedicine.com/doi/10.2217/nnm.13.138.
² Mesoporous Silica with Precisely Controlled Pores Reduces Food Efficiency and Suppresses Weight Gain in Mice, Nanomedicine, 2020, https://www.futuremedicine.com/doi/10.2217/nnm-2019-0262.
³ Entrapping Digestive Enzymes with Engineered Mesoporous Silica Particles Reduces Metabolic Risk Factors in Humans, Advanced Healthcare Materials,2020, https://doi.org/10.1002/adhm.202000057.
⁴ Towards mesoporous silica as a pharmaceutical treatment for obesity – impact on lipid digestion and absorption, European Journal of Pharmaceutics and Biopharmaceutics, 2022, https://doi.org/10.1016/j.ejpb.2022.02.001.
⁵ Oral intake of mesoporous silica is safe and well tolerated in male humans, PLoS ONE, 2020, DOI: 10.1002/adhm.202000057. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0240030
⁶ Engineered mesoporous silica reduces long-term blood glucose, HbA1c, and improves metabolic parameters in prediabetics, Nanomedicine, 2021,https://doi.org/10.2217/nnm-2021-0235.
⁷ Mesoporous Silica Particles Retain their Structure and Function While Passing Through the Gastrointestinal Tracts of Mice and Humans, ACS Applied Materials & Interfaces, 2023, https://doi.org/10.1021/acsami.2c16710.