Sigrid Therapeutics Completes Enrollment in SHINE to Evaluate SiPore21® Gel for Sustained Blood Sugar and Weight Management

• SiPore21® offers a non-pharmaceutical oral alternative to injectable drugs for sustainable blood sugar and weight management with no reported loss of lean body mass.
• SiPore21® is a gel containing micron-sized mesoporous silica particles (MSPs) that block digestive enzyme-food interactions.
• SHINE is the largest ongoing clinical study of its kind, having exceeded its enrollment target with 318 patients with elevated blood sugar levels and excess weight.
• SHINE’s primary endpoint is to determine the ability of SiPore21® to reduce patients’ HbA1c levels compared to placebo.
• Preliminary results are expected by the end of 2024.
• Siftel report predicts major opportunity for SiPore21® in the consumer market.

Stockholm, July 30th, 2024: Sigrid Therapeutics announced today the completion of enrollment for the SHINE clinical trial, which evaluates its breakthrough device, SiPore21®, for sustained diabetes control. A total of 318 patients have been enrolled, surpassing the original target of 288. SHINE is a randomized, double-blind, placebo-controlled multicenter trial taking place at 27 clinics across three European countries. The largest ongoing trial of its kind, SHINE has enrolled participants between the ages of 18 and 70 who are living with excess weight or obesity and are diagnosed with prediabetes or type 2 diabetes.

SHINE’s primary endpoint is to assess SiPore21®'s ability to sustainably reduce blood sugar levels compared to placebo. Secondary endpoints include body weight, body fat mass, and sagittal abdominal diameter. In a prior clinical study involving individuals with prediabetes using an earlier version of the SiPore21® device, patients demonstrated a 40% greater reduction in HbA1c levels and achieved these results in half the time compared to those using Metformin, the standard medication for type 2 diabetes.

If successful, Sigrid plans to register SiPore21® as a breakthrough medical device class IIb in the EU. This would pave the way for a powerful and accessible non-pharmaceutical tool to address two of the largest global health challenges: diabetes and obesity.

Kirsi Pietiläinen, Gyllenberg Professor in Clinical Metabolism at the Obesity Research Unit, University of Helsinki, and Principal Investigator (PI) on SHINE, stated: “I am delighted to report that enrollment for SHINE has been completed. We observed excellent patient compliance and a very low dropout rate during our visits to the clinics. Importantly, no dropouts were initiated by the investigators themselves. We are on track to complete the study in October and report initial results by year-end. SiPore21® represents a user-friendly, natural approach to blood sugar control and weight management, establishing a pivotal role in the expansive arsenal required for effective diabetes prevention and enhancing global health outcomes."

Sana Alajmovic, Co-founder & CEO of Sigrid Therapeutics, said: “In the ongoing search for sustainable treatments for sustainable blood sugar and weight management, we believe SiPore21® answers many questions on safety, efficacy, and sustainability. According to a major sector report by Siftel, SiPore21® was highlighted as one of the most promising over-the-counter weight management products.[1] As we reach this milestone of completing patient enrolment in SHINE, Sigrid is actively engaged in discussions with global industry leaders who have shown strong interest in bringing SiPore21® to market. We are 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 towards product launch.”

Prof. Tore Bengtsson, Co-founder & CSO of Sigrid Therapeutics, concluded: “Patient-friendly, safe, and without negative effects on lean body mass, SiPore® technology could offer a much-needed non-pharmaceutical alternative to injectable drugs for sustainable blood sugar and weight management. Reuters recently reported that the majority of patients discontinue injectable treatments within two years, primarily due to cost and side effects.[2] SiPore21® could address these concerns and help prevent the common weight regain that follows 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 Nanomedicine (1,2) 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 Materials (3) 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 control (4).

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 profile (3-7). 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 fats (8). 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