Sigrid Therapeutics Announces First Patient Treated with SiPore21[®] Medical Device for Sustained Diabetes and Obesity Control

SiPore21® Silica "Molecular Sieves" Offer a Promising Non-Pharmaceutical Alternative

SHINE Trial Marks a Milestone in Prediabetes and Weight Control Research

Stockholm, October 9^th, 2023: Sigrid Therapeutics is pleased to announce the commencement of the SHINE clinical trial for SiPore21® – an innovative medical device designed for sustained diabetes and weight control. Based on Mesoporous Silica particles (MSPs), SiPore21® represents a groundbreaking approach to managing these pressing health concerns. Administered orally in gel form, MSPs act as "molecular sieves," physically preventing digestive enzymes from interacting with food, thereby reducing the breakdown of carbohydrates and fats.

Addressing an Urgent Health Crisis: Prediabetes and obesity continue to pose a global health challenge. The SHINE trial, the largest commercial prediabetes study currently underway, aims to evaluate the effectiveness of SiPore21® in addressing this crisis. The primary endpoint of the trial is to assess whether SiPore21® treatment leads to a significant reduction in HbA1c levels, compared to a placebo, in obese or overweight individuals with elevated blood glucose levels.

A Potential Game-Changer: With successful results from the SHINE trial, SiPore21® is poised to be registered as a Class IIb medical device. This milestone paves the way for a powerful and accessible non-pharmaceutical tool to combat the growing global diabetes and obesity health crisis.

Comprehensive Evaluation: SHINE has been meticulously designed as a randomized, double-blinded, placebo-controlled, multicenter clinical investigation in accordance with Medical Device Regulation article 62. The trial's secondary endpoints encompass a wide range of health parameters, including body weight, insulin resistance, lipid levels, and more.

Recruitment and Protocol: SHINE seeks to recruit 288 male and female patients aged between 18-70 at 20 sites in three European countries. These individuals will have specific baseline criteria, including HbA1c levels, BMI, and meal patterns. Participants will undergo a 12-week routine of orally consuming SiPore21® gel packs at the start of their main meals, along with specific instructions for water intake.

A Critical Need: Kirsi Pietiläinen, Gyllenberg Professor in Clinical Metabolism at the Obesity Research Unit, University of Helsinki and Principal Investigator (PI) on SHINE, emphasizes, "In the realm of prediabetes management, there's a significant unmet medical need for accessible and user-friendly tools. SiPore21® has the potential to fill this gap effectively. Its innovative approach aligns with the demand for non-pharmaceutical solutions that empower individuals to take control of their health. SiPore21® addresses this critical need, offering hope in the fight against the growing prediabetes epidemic."

A User-Friendly and Natural Approach: Sana Ajamovic, CEO of Sigrid Therapeutics, adds, "At Sigrid, we are entering an exciting phase of development with the launch of the SHINE clinical trial for SiPore21®. Our innovative technology represents a user-friendly, natural approach to blood sugar control and obesity management, setting it apart from modern-day diabetes and obesity pharmaceuticals. We truly believe SiPore21® is going to make a positive impact on the healthcare landscape by preventing diabetes and improving human health worldwide."

Anticipated Milestones: SHINE is scheduled to complete recruitment in the first half of 2024, with preliminary reporting expected end of Q2, 2024.

For more information, please contact:

Kirsi Pietiläinen, Gyllenberg Professor in Clinical Metabolism at the Obesity Research Unit, University of Helsinki, Principal Investigator SHINE
Phone:  +358 50 5992295
Email: kirsi.pietilainen@helsinki.fi

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

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 healthtech 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, 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 profile^3-7. SiPore21® benefits from a unique mode of action, employing a 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.