Sigrid Therapeutics Surpasses the 50% Enrollment Milestone in its Clinical Trial, SHINE, to Evaluate the SiPore21® Gel for Sustained Diabetes and Obesity Control

• SHINE is the largest ongoing clinical study of its kind, marking a milestone in research on prediabetes and weight control. It involves individuals who are living with excess weight or obesity and have prediabetes or type 2 diabetes.
• SiPore21® Silica "Molecular Sieves" is a promising, non-pharmaceutical oral alternative to injectable drugs for sustainable weight control.

Stockholm, April 30th, 2024: Sigrid Therapeutics announced today that it has enrolled more than half of the necessary participants for its clinical trial SHINE of SiPore21®. SHINE is a randomized, double-blind, placebo-controlled multicenter trial taking place at 27 clinics in three European countries. SHINE will enroll 288 participants between the ages of 18 and 70 who are living with excess weight or obesity and have elevated blood glucose levels. Upon successful outcome, SiPore21® is poised to be registered as a breakthrough medical device class IIb in the EU, paving the way for a powerful and accessible non-pharmaceutical tool capable of combating the two largest global health challenge - diabetes and obesity.

In a prior clinical study of individuals with prediabetes, using a precursor of the SiPore21® medical device, patients exhibited a reduction in HbA1c levels that was 40% larger and achieved in half the time compared to Metformin, the standard medication for type 2 diabetes treatment.

The primary objective and endpoint of SHINE is to assess whether treatment with SiPore21® results in a more substantial reduction in HbA1c levels (relative to baseline) compared to placebo. Secondary endpoints include body weight, body fat mass and sagittal abdominal diameter.  

Kirsi Pietiläinen, Gyllenberg Professor in Clinical Metabolism at the Obesity Research Unit, University of Helsinki, and Principal Investigator (PI) on SHINE said: “The study is making good progress and we are grateful to the clinics for the quality of their work. During our visits to the clinics, we observed excellent patient compliance, accompanied by an exceptionally low dropout rate. Crucially, the safety of the study is underscored by the fact that none of the dropouts were initiated by the investigators themselves.We now look forward to including the remaining patients and to completing the study after the summer. SiPore21® represents a user-friendly, natural approach to blood sugar control and obesity management, establishing a pivotal role in the expansive arsenal required for effective diabetes prevention and enhancing global health outcomes."

Sana Alajmovic, CEO of Sigrid Therapeutics, stated: “As SHINE trial results approach, Sigrid is actively engaged in discussions with numerous global industry leaders, demonstrating strong interest in bringing the SiPore21® product to market. With momentum building, Sigrid is swiftly advancing negotiations to commercialize SiPore21® as a medical device in the EU and as a medical food in the US. The opportunity to partner with us in this groundbreaking venture is time-sensitive, as we move swiftly towards product launch.”

Prof. Tore Bengtsson, CSO of Sigrid Therapeutics concluded: “The SiPore® technology offers a unique non-pharmaceutical alternative to injectable drugs for sustainable blood sugar management, curbs hunger sensations, and reduces bloating. We are excited about the prospect of SiPore21® being a gentler and safer way of achieving sustainable weight control without negative side effects on lean body mass. For patients who discontinue treatment with injectable drugs, SiPore21® could be a way to safeguard against the common weight regain that follows after stopping such treatments.”

For more information, please contact:

Sana Alajmovic, Co-founder & CEO, Sigrid Therapeutics
Phone: +46 72 3893396
Email: sana@sigridthx.com

RHA Communications

Ola@rhacomms.eu / Richard@rhacomms.eu

About Mesoporous silica particles (MSPs)

Mesoporous silica particles (MSPs) are a type of ingestible, synthetic, amorphous silica particle 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 significantly 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 which reduces the breakdown of food and thus reduces 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 a control4.

About Sigrid Therapeutics

Sigrid Therapeutics (Sigrid) is a clinical-stage, consumer focused healthtech company pioneering a new class of engineered materials to prevent and treat metabolic diseases and disorders, including type 2 diabetes. The Company’s lead product, 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 SiPore® technology on a range of metabolic parameters and its excellent safety profile3-7. SiPore21® benefits from a unique mode of action, employing  mechanical entrapment of amylase and lipase within its porous structure. This physically hinders the interaction of digestive enzymes with food, effectively reducing the breakdown of carbohydrates and fats8. SiPore21® is being developed as the first oral medical device for blood sugar control 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.
8. 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.