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Sigrid Therapeutics announces publication of scientific study showing Mesoporous Silica Particles retain their structure and function while passing through the gastrointestinal tract

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Results back use of MSPs for novel diabetes and obesity treatments

Stockholm, February 22, 2023: Sigrid Therapeutics today announced the publication of a scientific study featured on the cover of the peer-reviewed journal ACS Applied Materials & Interfaces demonstrating that micron-sized mesoporous silica particles (MSPs) retain their structure and function while passing through the gastrointestinal tract (GIT). The results strongly suggest that orally ingested MSPs can safely be used for several clinical applications including diabetes and obesity where they act as “molecular sieves”, physically preventing digestive enzymes from interacting with  food and consequently reducing the breakdown of carbohydrates and fats. Sigrid is set to initiate the world’s second largest commercial pre-diabetes clinical study this year with lead candidate SiPore21®.

Professor Tore Bengtsson (Stockholm University), Sigrid Co-founder and CSO comments: “The structure and function of Mesoporous silica can be tailored for a plethora of application areas, including diabetes and obesity. The present results explicitly show that these particles stay intact after having passed through the gastrointestinal tract. The concept that these particles are working locally with no systemic absorption together with the excellent safety and efficacy shown previously in studies in both animals and patients makes us very encouraged to further exploring the clinical usage of these marvelous little particles.”

In this study, the MSPs were orally administered in a murine model and clinically in humans.  By characterizing the MSPs particles physically, structurally, morphologically, and functionally before and after passage of the GIT it has been shown that the MSP particles are not broken down to any substantial degree and that they retained their function in both animals and humans.

The fact that these particles are not absorbed into the body can be ascribed to their small (micron) size and that they are ingested as agglomerates thereby being too big to pass the intestinal barrier.

Title and link to the scientific publication:

Mesoporous Silica Particles Retain their Structure and Function While Passing Through the Gastrointestinal Tracts of Mice and Humans, ACS Applied Materials & Interfaces, 2023, Volume 15, Issue 7, https://doi.org/10.1021/acsami.2c16710

For more information, please contact:

Tore Bengtsson, Professor at the Department of Molecular Biosciences, Stockholm University

Phone +46 70 5473994,

Email: Tore.Bengtsson@su.se

About Mesoporous silica particles (MSPs)

Mesoporous silica particles (MSPs) are a type of ingestible synthetic amorphous silica particles that can be produced with a large surface area and a range of pore sizes. Studies in mice, published in Nanomedicine1,2 have shown that food efficiency was reduced by 33% leading to a positive effect on metabolic profile with significant lower levels of adipose tissue formation and leptin, together with lower levels of circulating insulin. Weight gain was thus sufficiently attenuated. Additional pre-clinical results published in Advanced Healthcare Materialsshowed that these findings are compatible with a mode of action whereby a portion of the enzymes are trapped inside the MSPs resulting in an enzyme-blocking effect reducing the break down of food and thus reducing the energy uptake into the body.This mode of action was further confirmed in vivo when MSPs added to milk led to reduced lipid absorption compared to control4.

About Sigrid Therapeutics

Sigrid Therapeutics (Sigrid) is a clinical-stage consumer focused health tech company pioneering a new class of engineered materials to prevent and treat metabolic disease and disorders, including type 2 diabetes. The Company’s lead product candidate, SiPore21®, is an orally-administered medical device based on the Company’s proprietary platform technology, SiPore®. Designed to act locally in the gut, SiPore21® consists of precisely engineered micron-sized mesoporous silica particles (MSPs) with tailored porosity. Clinical data confirms the beneficial effects of MSPs on a range of metabolic parameters and their excellent safety profile3,5,6. Upon its approval, SiPore21® will be the first medical treatment available for reduction of blood sugar levels in people at risk of developing type 2 diabetes. https://www.sigridthx.com/.
 

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

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The structure and function of Mesoporous silica can be tailored for a plethora of application areas, including diabetes and obesity. The present results explicitly show that these particles stay intact after having passed through the gastrointestinal tract. The concept that these particles are working locally with no systemic absorption together with the excellent safety and efficacy shown previously in studies in both animals and patients makes us very encouraged to further exploring the clinical usage of these marvelous little particles
Professor Tore Bengtsson (Stockholm University), Sigrid Co-founder and CSO