Sigrid Therapeutics Announces Last Patient Last Visit in SHINE Clinical Trial Evaluating SiPore21® Gel for Sustained Blood Sugar Control

• Sigrid Therapeutics announces the completion of the final patient visit in its SHINE clinical trial—the largest of its kind—surpassing the planned enrollment of 288 with a total of 318 participants.
   
• SiPore21® gel has the potential to be the first medically approved treatment specifically targeting blood sugar control in individuals living with prediabetes.
   
• SiPore21® gel offers a non-pharmaceutical alternative to GLP-1 treatments and a pathway to sustained adherence for for those affected by prediabetes.
   
• Top-line results are anticipated in Q1 2025, positioning SiPore21® for CE marking and accelerated market access as a medical food in the U.S.
   
• With the growing global need for effective metabolic health solutions, SiPore21® represents a breakthrough opportunity for strategic partnerships and investment in the fast-growing metabolic health sector.

Stockholm, Sweden, November 4, 2024 – Sigrid Therapeutics is pleased to announce that the last patient in its groundbreaking SHINE clinical trial evaluating SiPore21® for sustained blood sugar control has completed their final visit. Notably, the trial exceeded its enrollment target, with 318 patients enrolled, up from the original goal of 288. This important milestone brings the company one step closer to revolutionizing how prediabetes and early-stage type 2 diabetes are managed globally.

Prediabetes, a condition that affects more than 1 in 3 adults in the U.S. and is rising rapidly worldwide, represents a massive and underserved market with significant growth potential. With limited treatment options currently available—most of which rely on lifestyle changes or off-label use of metformin meant for managing type 2 diabetes—SiPore21® aims to become a first-of-its-kind solution to address this unmet medical need.

Real-world evidence shows that adherence to newer medications, such as GLP-1 receptor agonists, is a significant challenge for individuals living with prediabetes due to side effects and long-term compliance issues​.[1] This underscores the urgent need for novel, patient-friendly options like SiPore21® that can offer similar benefits without these adherence challenges.

SHINE Trial and SiPore21® Efficacy 
The SHINE trial, a randomized, double-blind, placebo-controlled study across 27 sites in Europe, is the largest of its kind. The trial's primary endpoint focuses on SiPore21®’s ability to reduce HbA1c levels, a critical indicator of long-term blood sugar control. Secondary endpoints include SiPore21®’s impact on body weight, fat mass, and other metabolic factors.

In prior trials, a SiPore21® precursor demonstrated a significant reduction in HbA1c compared to metformin, achieved in half the time, positioning it as a powerful alternative to current blood sugar control treatments.

Sana Alajmovic, Co-Founder & CEO of Sigrid Therapeutics, commented: “Our goal with SiPore21® is to provide an accessible, non-pharmaceutical solution for blood sugar control, empowering millions of individuals worldwide to manage their metabolic health proactively. The high patient interest and remarkably low dropout rate of 6% in the SHINE trial underscore the strong demand for innovative, patient-friendly treatments in this space. Large-scale diabetes studies show that even a modest reduction in HbA1c could delay type 2 diabetes onset by several years, significantly improving public health and reducing healthcare costs globally.”

Positioned for Rapid Market Expansion and Strategic Partnerships
SiPore21® is an innovative, easy-to-use gel with micron-sized mesoporous silica particles (MSPs) that, when taken orally, work locally in the gut to physically separate digestive enzymes from undigested food. This unique mechanism slows the breakdown of carbohydrates and fats, reducing overall energy intake and helping to control blood sugar levels. Over time, this supports better blood sugar management, reflected in lower long-term blood glucose (HbA1c) levels. Earlier trials of a SiPore21® precursor showed significant reductions in HbA1c levels compared to metformin, achieved in half the time, further validating the potential of this technology to redefine blood sugar control.

The results from the SHINE trial will be instrumental in compiling SiPore21®’s technical file for CE marking in Europe as a Class IIb medical device. In the U.S., Sigrid Therapeutics is positioned for rapid market entry through an updated medical food dossier, offering immediate opportunities for commercialization.

Given the rising global need for accessible solutions to support individuals managing prediabetes and type 2 diabetes, SiPore21® presents a significant commercial opportunity for strategic partnerships and investment. This product is uniquely positioned to meet the demands of a fast-growing sector focused on metabolic health, nutritional supplements, and medical devices. These regulatory steps set the stage for global commercialization, opening doors for potential collaborations that can accelerate SiPore21®’s market reach and impact.

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 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 helps 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, SiPore21®—an orally administered medical device designed to improve metabolic function. SiPore21® 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 fats⁵. 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, SiPore21® 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.