Sigrid Therapeutics reports positive results from consumer blood sugar management trial using SiPore® formulated dietary supplements in pre-diabetics, type 2 diabetics, and obese individuals

“Molecular sieves” swallowed in capsules and gels reported safe, easy to digest and effective

Stockholm, March 8^th 2023. Sigrid Therapeutics, an innovative, consumer-oriented health tech company today released the results of a pre-launch consumer trial of their clinically proven technology SiPore® for blood sugar management in prediabetics and type 2 diabetics. Two hundred and nine volunteers took part in the 6-week program, with the majority reporting overwhelmingly positive, subjective ratings from using the SiPore® dietary food supplements. 

During the program, the subjects ingested the product twice daily together with their two main meals. The subjects experiences and opinions were collected in a questionnaire filled out before and after the program. No less than 94% of the users felt safe using SiPore®, 84% were satisfied with SiPore® and 84% would recommend SiPore® to a friend. The following statements resonated strongly with the participants: It is a natural substance; it is scientifically and clinically proven and it has a Swedish origin. See the attached white paper for individual comments on experiences regarding e.g. blood sugar control, weight loss and daily energy levels.

“Although we have seen clinically significant effects of the SiPore® technology in previous clinical trials including a 40% larger HbA1c reduction compared to Metformin in prediabetics^*, the overwhelmingly positive, subjective ratings from the users exceeded our expectations”, says Sigrid Therapeutics, co-founder and CEO, Sana Alajmovic.

“Even more inspired to move forward in our development, we are now preparing to launch SiPore® as 1) a dietary supplement for the US market, 2) a veterinary products, primarily for cats and 3) within oral health. In parallel, we are advancing the SiPore® technology as medical device in the EU and are set to start a large clinical study in 287 patients who are either overweight or obese and suffering from prediabetes or type 2 diabetes.”

^*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

Read more in our SiPore® white paper accessible here: https://www.sigridthx.com/white-paper

For more information, please contact:

Sana Alajmovic, Co-Founder & CEO, Sigrid Therapeutics

Phone +46 72 389 3396,

Email: sana@sigridthx.com

About type 2 diabetes and pre-diabetes

Type 2 diabetes is increasing exponentially worldwide. The total number of people living with diabetes is projected to rise to 643 million by 2030 and 783 million by 2045. Prediabetes is the precursor stage to type 2 diabetes. According to the International Diabetes Federation, 730 million people will suffer from prediabetes in 2045. At the same time, poor health is increasing in the population due to obesity and abdominal obesity is a known risk factor for suffering from prediabetes.

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 Nanomedicine^1,2 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 Materials³ showed 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 profile^3,5,6. 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, ttps://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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