Sigrid Therapeutics one step closer to preventive treatment of type 2 diabetes

Sigrid Therapeutics reports significant blood sugar reduction and excellent safety profile in the STAR study with SiPore15, a groundbreaking medical device for prediabetes and untreated type 2 diabetes

Stockholm, September 26, 2019 - Sigrid Therapeutics AB, an innovative technology company developing a new class of silica-based products for metabolic diseases, today reports the first results from the STAR Proof of Concept study in individuals with prediabetes and untreated type 2 diabetes. Intake of SiPore15, a non-absorbable, orally administered medical device, resulted in a 1.4 mmol/mol reduction in HbA1c, a key marker of blood glucose control (p=0.0391). Intake of SiPore15 did not contribute to any increased safety risk and no serious adverse events were noted. The reduction in HbA1c was at the same level as previously reported in drug studies in prediabetics but with a more favorable safety profile than systemic drugs.

"The STAR study not only verifies the excellent safety profile of SiPore15 but also confirms a clinically relevant reduction in blood sugar in individuals who currently lack new and safer solutions to prevent type 2 diabetes," says Professor, MD, PhD Kirsi Pietiläinen, coordinating investigator of the STAR study.

The STAR study (Sigrid Therapeutics HbA1c Reduction) is an open-label, single-arm, multicenter study with the aim of demonstrating the safety and efficacy of SiPore15 in people with prediabetes or untreated type 2 diabetes. The primary efficacy variable is the reduction in long-term blood glucose levels, measured as HbA1c, after 12 weeks of treatment with SiPore15.

“This is the company’s most significant milestone to date and we are incredibly pleased with the positive results from our Proof of Concept study. The reduction in HbA1c with SiPore15 after 12 weeks of treatment was at the same level as that observed in multi-year studies with Metformin, the only drug that according to the American Diabetes Association can be considered for the treatment of selected patients with prediabetes. The fact that SiPore15 was so well tolerated is important as it is a significant competitive advantage compared to drugs that have systemic effects,” says Sana Alajmovic, CEO of Sigrid Therapeutics. “The 12-week follow-up period of the study is still ongoing and we look forward to reporting final results by the end of the year. The results will form the basis for approval of SiPore15 for marketing in the EU.”

Full results will be presented at a scientific conference and will be published in a scientific journal. Detailed information about the 24-week STAR study, which included 43 patients at two research clinics, one in Sweden and the other in Finland, can be found at www.clinicaltrials.gov/ct2/show/NCT03823027 and https://www.sigridthx.com .