First patient treated in Sigrid Therapeutics' clinical trial SHINE of the medical device SiPore21[®]

Stockholm, October 9, 2023 : Sigrid Therapeutics is pleased to announce the start of the SHINE clinical trial for SiPore21® – an innovative medical device designed for long-term maintenance of blood sugar and weight control. The product SiPore21®, which is based on mesoporous silica particles (MSP), represents a groundbreaking treatment option to tackle these pressing health issues. The product is administered orally in gel form and acts as a "molecular sieve" that physically prevents digestive enzymes from interacting with food, thereby reducing and slowing the breakdown of carbohydrates and fats.

An urgent health crisis in focus : Prediabetes and obesity continue to be a global health challenge. The SHINE study, the largest ongoing commercial prediabetes study to date, aims to evaluate the effectiveness of SiPore21® in addressing this crisis. The primary endpoint of the study is to evaluate whether SiPore21® treatment leads to a significant reduction in HbA1c levels (long-term blood sugar), compared to placebo. Both severely overweight and moderately overweight individuals with elevated blood sugar levels are included in the study.

A Potential Paradigm Shift : Successful results from the SHINE study pave the way for SiPore21® to be registered as a Class IIb medical device. Such a milestone paves the way for offering a powerful and easily accessible non-pharmaceutical treatment to address the growing global health crisis of prediabetes, diabetes and obesity.

Comprehensive evaluation : SHINE is a randomized, double-blind, placebo-controlled, multicenter clinical trial in accordance with Article 62 of the Medical Devices Regulation. The study's secondary endpoints include a wide range of health parameters including body weight, insulin resistance, lipid levels (fats in the blood).

Recruitment and protocol : SHINE will recruit 288 male and female patients aged 18 to 70 years at 20 clinics in three European countries. Study participants’ baseline HbA1c levels, BMI and meal patterns will be documented. They will then consume SiPore21® gel at the start of their main meals for 12 weeks according to specific meal and water intake instructions.

A critical medical need: Kirsi Pietiläinen, Gyllenberg Professor of Clinical Metabolism at the Obesity Research Unit, University of Helsinki and clinical trial leader for SHINE, emphasizes: "When it comes to managing prediabetes, there is a significant medical need for easily accessible and user-friendly methods. SiPore21® has the potential to effectively fill this gap. The innovative approach harmonizes with the demand for non-pharmaceutical solutions that empower individuals to take control of their health. SiPore21® addresses this critical need and provides 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 development phase 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, which sets it apart from today's diabetes and obesity drugs. We truly believe that SiPore21® will have a positive impact on healthcare worldwide by preventing diabetes and improving people's health."

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