Sigrid Therapeutics Secures US Patent for Groundbreaking SiPore[®] Technology in Blood Sugar Management

Stockholm, Sweden, December 2, 2024. The Swedish healthtech company Sigrid Therapeutics today announced that it has been granted a US patent for its SiPore^® platform technology. As an effective method of lowering blood glucose, SiPore^® promises to become a breakthrough treatment to reduce the risk of developing metabolic syndrome, type 2 diabetes, insulin resistance, or hyperglycaemia. 

The United States Patent Office (USPTO) has granted the company patent US 12,121,612 titled “Porous silica material for use as a pharmaceutical or dietary active ingredient”. The patent supports use of Sigrid’s mesoporous SiPore^® silica particles, which consist of precisely engineered micron-sized silica particles with tailored porosity, for lowering blood glucose levels. The patent also supports the use of the 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 groundbreaking 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," continued Robert-Nicoud. 

Sigrid's lead product candidate, SiPore^®21, is an orally administered solution classified as a Class IIB medical device in the European Union and as 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 delivered as 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. 

Sana Alajmovic, Co-founder & CEO of Sigrid Therapeutics, commented: “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. 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 patent EP2916852B1 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, UK, Switzerland, Norway, Iceland and Turkey.  

For more information, please contact:

Sana Alajmovic, Co-Founder & CEO, Sigrid Therapeutics 

Phone +46 72 389 3396, 

Email: sana@sigridthx.com

About SiPore^® Mesoporous Silica Particles (MSPs) 
SiPore^® mesoporous silica particles (MSPs) are an innovative, ingestible material engineered with a vast surface area and customizable pore sizes, offering transformative potential in metabolic health. 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 remarkable 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 Materials (3) 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 represent a cutting-edge approach to addressing metabolic disorders by targeting nutrient absorption directly in the gut. 

About Sigrid Therapeutics

Sigrid Therapeutics is an innovative clinical-stage healthtech company committed to transforming the management and prevention of metabolic diseases, including type-2 diabetes. Our breakthrough technology platform, SiPore^®, is the foundation of our lead product, SiPore^®21—an orally administered medical device designed to improve metabolic function. SiPore^®21 utilizes micron-sized mesoporous silica particles (MSPs) with precisely tailored porosity, acting locally in the gut to physically hinder digestive enzymes from breaking down carbohydrates and fats (5). This novel, non-systemic approach reduces blood sugar spikes and energy uptake, promoting healthier metabolic function without being absorbed into the body. Supported by robust clinical data, the SiPore^® technology demonstrates significant benefits across a range of metabolic markers while maintaining an excellent safety profile (3, 6-8). As the first oral medical device of its kind for blood sugar management in individuals living with prediabetes and type-2 diabetes, SiPore^®21 is set to redefine the treatment landscape with a new, patient-friendly option for millions worldwide. 

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. Activity and Stability of Nanoconfined Alpha-Amylase in Mesoporous Silica ACS MATERIAL Au, 2023, https://doi.org/10.1021/acsmaterialsau.3c00028. Publication date: August 4, 2023 

6. 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

7. 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. 

8. 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.