The company has reported 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 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.
“The company’s most significant milestone to date”
“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.”
Photo of Sana Alajmovic: Sigrid Therapeutics