Sigrid Therapeutics Secures U.S. Market Access for SiPore® Technology in Blood Sugar and Weight Management Following Landmark SHINE Study in Prediabetes

Stockholm, Sweden, March 10, 2025 — Sigrid Therapeutics (Sigrid) has achieved a major milestone, securing U.S. market access for its pioneering SiPore® technology after the successful completion of SHINE, the largest clinical study of its kind in prediabetes. The SHINE study demonstrated that Carb Fence™, a medical-grade, fast-acting liquid formula powered by SiPore®, significantly reduces long-term blood sugar levels (HbA1c), enhances glucose metabolism, and supports weight management while preserving muscle mass. These findings position Carb Fence™ as a breakthrough medical food, a category recognized by the FDA for managing diseases or conditions under physician supervision. In Europe, Sigrid is in advanced regulatory discussions to secure CE-mark approval for Carb Fence™ as a class IIb medical device.

A Game-Changer in Prediabetes Management

Prediabetes affects one in three U.S. adults, with few effective non-pharmaceutical solutions.^[1] Carb Fence™ is the first clinically validated medical food developed specifically for prediabetes, offering an easy-to-use alternative that seamlessly integrates into daily routines. Unlike pharmaceuticals, which often require prescriptions and carry systemic side effects, Carb Fence™ provides a non-systemic, gut-localized approach to metabolic health.

Strong Clinical Evidence Supports Market Readiness
The SHINE study^[2], designed as a double-blind, placebo-controlled, randomized trial, aimed to assess the safety and tolerability of SiPore®-powered Carb Fence™ while confirming its efficacy across key metabolic markers. Conducted across 27 clinics in three European countries, SHINE enrolled 318 participants with elevated blood sugar levels and excess body weight. Of these, 228 participants (116 in the active arm, 112 in the placebo group) strictly adhered to the protocol and were included in the primary analysis, which was based on the per protocol population. The study required no dietary or exercise interventions, allowing participants to maintain their normal lifestyle throughout the trial.

Compared to baseline, the study demonstrated:

- Significant HbA1c Reduction: A statistically significant reduction of -0.91 mmol/mol

(P = 0.001) in just three months, outperforming the six-month reduction seen in the Diabetes Prevention Program (DPP) metformin study.^[3]

- Enhanced Glucose Metabolism: Stabilization of HOMA-B (P = 0.0005), a key marker of pancreatic function.

- Cholesterol Improvements: LDL cholesterol levels dropped by -4.41 mg/dL
(P = 0.0172), reducing cardiovascular risk.

- Sustained Weight Loss: Participants lost -1.21% of body weight (P < 0.0001) while maintaining muscle mass, in contrast to GLP-1 drugs, where up to 40% of weight loss is lean mass.

- Exceptional Safety & Adherence: 97% of participants found it easy to use, and 95% reported feeling safe using it. 86% would recommend it to others with prediabetes or diabetes.

“The SHINE study validates SiPore® as an innovative, non-pharmaceutical approach to metabolic health, supporting blood sugar regulation, weight management, and cardiovascular health. The findings confirm that it preserves muscle mass while promoting fat loss, which is a significant advantage in tackling obesity and diabetes” said Kirsi Pietiläinen, Gyllenberg Professor in Clinical Metabolism at the Obesity Research Unit, University of Helsinki, and Principal Investigator for the study.

U.S. Commercial Strategy & Global Expansion

With the U.S. medical food market experiencing rapid growth, Sigrid plans to commercialize Carb Fence™ by year-end. Concurrently, the company is advancing CE-mark approval as a Class IIb medical device in Europe, setting the stage for expanded regulatory claims.

Sigrid has also secured an exclusive partnership with a global silica manufacturer to ensure production scalability. The company is actively engaging with healthcare providers, metabolic health specialists, and clinics seeking non-pharmaceutical alternatives, including those transitioning patients off GLP-1 therapies.

“The U.S. market access milestone marks a turning point for Sigrid and the future of metabolic health solutions,” said Sana Alajmovic, Co-Founder & CEO of Sigrid Therapeutics. “With Carb Fence™, we are offering a clinically proven, safe, and effective alternative to help millions take control of their metabolic health without pharmaceuticals.”

For more information, please contact: Sana Alajmovic 

Co-Founder & CEO, Sigrid Therapeutics 

Phone: +46 72 3893396 

Email: sana@sigridthx.com

About Sigrid Therapeutics

Sigrid Therapeutics (Sigrid) is a clinical-stage healthtech company pioneering non-pharmaceutical solutions for metabolic diseases like type 2 diabetes and obesity. With over 15 years of research, 10+ patents, and four clinical studies, the company’s proprietary SiPore® platform powers Carb Fence™, a medical grade, fast-acting liquid formula designed to regulate blood sugar, support weight management, and improve metabolic function without systemic absorption. For more information about Sigrid, visit:   https://www.sigridthx.com/

About Mesoporous Silica Particles (MSPs)

MSPs are an innovative, ingestible material engineered for metabolic health applications. Research published in Nanomedicine shows MSPs can reduce food efficiency by 33%, lower insulin levels, and decrease leptin, contributing to a healthier metabolic profile. Additional studies in Advanced Healthcare Materials confirmed MSPs physically trap digestive enzymes, reducing carbohydrate and fat breakdown.

Referenser

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