Sigrid Therapeutics Takes Another Step Towards a Treatment for Prevention of Type 2 diabetes
Sigrid Therapeutics Reports Significant Blood Sugar Reduction with Excellent Safety Profile in STAR Trial with Breakthrough Medical Device SiPore15 in Prediabetes and Untreated Type 2 Diabetes
Stockholm, Sweden, September 26, 2019 – Sigrid Therapeutics AB, an innovative technology company developing a new class of silica based therapies for metabolic diseases and disorders, today reports the first results from their Proof of Concept STAR study in subjects with prediabetes or newly diagnosed type 2 diabetes. The Company’s lead product, SiPore15, an orally administered non-absorbed medical device, demonstrated a 1,4 mmol/mol mean reduction in HbA1c, a key marker of glucose control (p=0.0391). SiPore15 showed no increased safety risk, no serious adverse events and no severe adverse events. The magnitude of the effect is similar to that previously reported in studies in prediabetes patients receiving systemic drug treatment but better tolerated.
“The STAR study not only demonstrates the excellent safety profile of SiPore15 but also confirms a clinically relevant reduction of blood sugar in patients in need of novel and safer solutions for prevention of type 2 diabetes.” says Professor, MD, PhD Kirsi Pietiläinen, Coordinating Investigator in the STAR study.
The STAR (Sigrid Therapeutics HbA1c Reduction) study is an open-label, single-arm, multicenter study with the objective to demonstrate the safety and efficacy of SiPore15™ in subjects with prediabetes or newly diagnosed type 2 diabetes. The primary endpoint is a reduction in long term blood sugar, as measured by HbA1c, after 12 weeks of treatment with SiPore15.
“This is the Company’s most significant milestone to date and we are very happy about the positive results from our Proof of Concept study. The reduction achieved in HbA1c with SiPore15 after 12 weeks of administration was similar to that of large, years-long, studies with Metformin, the only drug considered for treatment of selected patients with prediabetes by the American Diabetes Association. Importantly, SiPore15 was very well tolerated, which is a significant competitive advantage over systemically acting drugs.” says Sigrid Therapeutics CEO Sana Alajmovic. “The 12 week follow up period of the study is still ongoing and we look forward to reporting final results by the end of this year as we are working towards obtaining device clearance to market SiPore15 in EU.”
Full results will be presented at a scientific conference and will be submitted for publication in a peer-reviewed medical journal. Details of the 24-week STAR study, which involved 43 patients at two sites, one in Sweden, the other in Finland, can be found at www.clinicaltrials.gov/ct2/show/NCT03823027 and https://www.sigridthx.com.
For more information, please contact:
Sana Alajmovic, Co-Founder & CEO, Sigrid Therapeutics
Phone +46 72 389 3396,
TO THE EDITORS
About Sigrid Therapeutics AB
Sigrid Therapeutics (Sigrid) is a clinical-stage technology 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, SiPore15, is an orally administered medical device based on the Company’s proprietary platform technology, SiPore. Designed to act locally in the gut, SiPore15, consists of precisely engineered micron-sized silica particles with tailored porosity. A First in Man clinical trial of SiPore15 showed promising clinically significant results and an excellent safety profile. A second clinical trial STAR with SiPore15 is ongoing, with complete results expected in the fourth quarter of 2019. Upon its approval, SiPore15 will be the first medical device available for reduction of blood sugar levels in people at risk of developing type 2 diabetes.