Positive results from Sigrid Therapeutics proof-of-concept prediabetes STAR
First-in-Class Medical Device SiPore15® – based therapy significantly reduced long-term blood sugar levels and improved metabolic parameters in prediabetics.
Sigrid Therapeutics AB, an innovative technology company developing a new class of silica-based therapies for metabolic diseases and disorders, today announce that the results from their Proof-of-Concept STAR study have been published in Nanomedicine.
Oral administration of the Company’s lead product SiPore15® to subjects with prediabetes or newly diagnosed type 2 diabetes resulted in a significant and clinically meaningful reduction in HbA1c, a key marker of glucose control. The treatment also improved several disease-associated parameters while side effects were minimal. The news follows the recent, over-subscribed capital raise and the signing of a major manufacturing deal with Japan’s AGC for production of SiPore15®.
Tore Bengtsson
The main finding of this study was that SiPore15® treatment in individuals with prediabetes or newly diagnosed type 2 diabetes significantly reduced HbA1c levels to a clinically relevant degree. The HbA1c level was significantly reduced in the all-participants group (N=38) after 6 weeks of SiPore15® treatment (p = 0.0025) and showed a significant decreasing trend over the entire 12-week treatment period (p = 0.0209). Reduction in HbA1c level in prediabetics and newly diagnosed type 2 diabetics was independent of body weight and BMI.
In one group of patients, HbA1c levels significantly decreased by 1.04 mmol/mol from baseline after 6 weeks and was further reduced to 1.44 mmol/mol after 12 weeks of SiPore15® administration. This magnitude of reduction has been shown to reduce diabetes incidence in prediabetics by 31% and is comparable to what has been achieved by a currently advised scheme for the treatment of prediabetes.
“This Proof-of-Concept study in humans confirms the results from our First in Man study and preclinical research ”, says Tore Bengtsson, Professor at Stockholm University, co-founder and CSO of Sigrid Therapeutics. “The results from this study demonstrate the potential use of SiPore15® as a treatment for prediabetes that may also delay or prevent the onset of type 2 diabetes.”
Sana Alajmovic, Co-Founder & CEO of Sigrid Therapeutics, comments: “We are delighted to see that the results of our STAR trial has been published in such a prestigious peer-reviewed scientific journal as Nanomedicine. We recently raised $8.4 million to be used for a pivotal, placebo-controlled, double-blind, multicenter clinical study called SHINE that will form the basis for CE-marking in the EU and is set to start enrolling patients the second half of 2022.”