Sigrid Therapeutics STAR Trial of SiPore15TM Showing Rapid Progress
Stockholm, Sweden, 4th June 2019 - First-in-Class MSP (mesoporous silica particle) based therapy targets blood sugar and other metabolic risk factors
Sigrid Therapeutics AB, a biotechnology company developing a new class of therapies for metabolic diseases and disorders, today announces that it has already completed treatment of 25% of patients in the STAR trial of its first-in-class medical device, SiPore15, and is well on track to finalize results by Q4 of this year. The Company also reports that treatment compliance is good and the safety profile continues to look positive. STAR aims to demonstrate that the specially engineered mesoporous silica particle (MSP) can achieve a significant reduction in key cardio-metabolic risk factors - blood sugar, blood lipids and body fat composition – in both prediabetics and newly diagnosed type 2 diabetics.
Details of the 24-week STAR (Sigrid Therapeutics HbA1c Reduction), which involves 40 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.
Sana Alajmovic, Co-Founder & CEO of Sigrid Therapeutics, states: “We are delighted that enrolment in STAR has progressed smoothly, enabling us to be on track for reporting results in October as previously stated. All of the patients have already received the orally-administered particles, which are intended to safely reduce blood sugar and other risk factor levels in prediabetic and newly diagnosed type 2 diabetics and pave the way towards regulatory approval.”
About Sigrid Therapeutics
Sigrid Therapeutics (Sigrid) is a clinical-stage biotech company pioneering a new class of engineered materials to prevent and treat metabolic disease and disorders, including type 2 diabetes. The Company’s lead product candidate, 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. The design of the STAR study has been developed in discussions with Notified Bodies, allowing filing for regulatory approval upon successful trial completion. 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.