Sigrid Therapeutics surpasses 50% patient recruitment in its clinical trial, SHINE, evaluating SiPore21® for sustainable diabetes and obesity control

Stockholm, April 30, 2024: Sigrid Therapeutics announced today that the company has recruited over 50% of patients in SHINE, a clinical trial evaluating SiPore21® for the treatment of elevated glucose levels. SHINE is a randomized, double-blind, placebo-controlled multicenter trial conducted at 27 clinics in three European countries. SHINE will evaluate 288 participants between the ages of 18 and 70 who are overweight or obese and have elevated blood glucose levels. If the trial is successful, SiPore21® is ready for registration as a breakthrough medical device class IIb in the EU, paving the way for an effective and accessible non-pharmaceutical treatment that can combat the two biggest global health challenges, diabetes and obesity.

In a previous clinical study in prediabetics where a previously developed, similar version of SiPore21® was evaluated, patients showed a 40% greater reduction in HbA1c levels in half the time compared to Metformin, the standard treatment for type 2 diabetes.

The primary objective of SHINE is to evaluate whether treatment with SiPore21® results in a more significant reduction in HbA1c levels (relative to baseline) compared to placebo. Secondary endpoints include body weight, body fat mass and sagittal abdominal diameter.

Kirsi Pietiläinen, Gyllenberg Professor of Clinical Metabolism at the Obesity Research Unit, University of Helsinki, and Principal Investigator (PI) of SHINE says: "The study is progressing well and we are grateful for the excellent work carried out at the clinics. During our visits to the clinics, we observed that patient compliance was excellent and that the number of patients who chose to drop out was exceptionally low. The good safety profile of the study so far is underlined by the fact that none of the dropouts were initiated by the medical staff. We now look forward to enrolling the remaining patients and completing the study after the summer. SiPore21® represents a user-friendly, natural approach to blood glucose control and obesity management, and will play a central role in the expansive arsenal required for effective diabetes prevention and health improvement globally."

Sana Alajmovic, CEO of Sigrid Therapeutics, says: " As the results of the SHINE study approach, Sigrid is actively engaged in discussions with many global, leading companies in the industry, demonstrating a strong interest in bringing the SiPore21® product to market. With the strong momentum that has been built, Sigrid is rapidly advancing negotiations to commercialize SiPore21® as a medical device in the EU and as a medical food in the US. The opportunity for partnerships for our groundbreaking product is time-critical as we rapidly approach product launch."

Prof. Tore Bengtsson, CSO at Sigrid Therapeutics summarizes: " The SiPore21® technology offers a unique non-pharmaceutical alternative to injectables for sustainable blood sugar management, and the ability to reduce hunger and bloating. We are excited about the potential that SiPore21® can be a gentler and safer way to achieve sustainable weight control without negative side effects on lean muscle mass. For patients who discontinue treatment with injectables, SiPore21® can be a way to curb the usual weight gain that follows the termination of such treatments."