Sigrid Therapeutics completes recruitment into SHINE, a study evaluating SiPore21® Gel for long-term blood sugar and weight control

Stockholm, July 30, 2024: Sigrid Therapeutics announced today that recruitment to the SHINE clinical trial, which is evaluating the company's breakthrough product SiPore21® for long-term diabetes control, has been completed. A total of 318 patients have been recruited, exceeding the initial target of 288 individuals. SHINE is a randomized, double-blind, placebo-controlled, multicenter study being conducted at 27 clinics in three European countries. SHINE, which is the largest ongoing study of its kind, has recruited participants aged 18 - 70 years who are living with overweight or obesity and who have been diagnosed with prediabetes or type 2 diabetes.

SHINE's primary endpoint is to evaluate the ability of SiPore21® to reduce blood sugar levels over the long term compared to placebo. Secondary endpoints include body weight, body fat mass and sagittal abdominal diameter. In a previous clinical study of individuals with prediabetes who received an earlier version of SiPore21®, patients showed a 40% greater reduction in HbA1c levels, achieved in half the time compared to those using Metformin, the standard drug for type 2 diabetes.

If the trial is 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 treatment that can address two of the biggest global health challenges: diabetes and obesity.

Kirsi Pietiläinen, Gyllenberg Professor of Clinical Metabolism at the Obesity Research Unit, University of Helsinki and Principal Investigator (PI) of SHINE, stated: “I am pleased to report that recruitment to SHINE is complete. During our visits to the clinics, we have noted that patient compliance was excellent and that the incidence of dropouts was very low, and of the few dropouts, none were initiated by the investigators themselves. We are now on track to complete the study in October and report initial results by the end of the year. SiPore21® represents a user-friendly, natural approach to controlling blood glucose levels and body weight, thus playing a central role in the comprehensive arsenal of options required for effective diabetes prevention and improved global health.”

Sana Alajmovic, Co-Founder and CEO of Sigrid Therapeutics, said: “In the ongoing search for sustainable treatments to control blood sugar levels and body weight, we believe that SiPore21® offers many answers regarding safety, efficacy and sustainability. According to a major report on the obesity market by Siftel [1] , SiPore21® was highlighted as one of the most promising OTC products for weight management. As we reach this milestone of completing patient recruitment in SHINE, we are actively engaged in discussions with global industry players who have already shown strong interest in bringing SiPore21® to the market. We are rapidly advancing in 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 on this groundbreaking project is time-critical as we approach product launch.”

Prof. Tore Bengtsson, Co-Founder and Chief Scientific Officer of Sigrid Therapeutics, concluded: “By being a patient-friendly and safe product with no negative effects on muscle mass, SiPore® technology can offer a much-anticipated, non-pharmaceutical alternative to injectables for sustainable blood sugar and weight control. Reuters recently reported that the majority of patients discontinue injectable treatments within two years, primarily due to cost and side effects [2] . SiPore21® can address these issues and help prevent the common weight gain that follows discontinuation of such treatments.”