Positive results from Sigrid Therapeutics proof-of-concept prediabetes STAR study published in Nanomedicine
First-in-Class Medical Device SiPore15® - based therapy significantly reduced long-term blood sugar levels and improved metabolic parameters in prediabetics.
Stockholm, Sweden, December 13, 2021 – 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®.
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® administration1. This magnitude of reduction has been shown to reduce diabetes incidence in prediabetics by 31%2 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.”
For further information, please contact:
Sana Alajmovic – CEO, Sigrid Therapeutics AB
Telephone: +46 72 389 3396
Email: sana@sigridthx.com
About SiPore15®
SiPore15® is a first-in-class medical device using specially engineered mesoporous silica particles (MSP) to achieve a reduction in blood sugar – in both prediabetics and newly diagnosed type 2 diabetics. SiPore15® functions as a mechanical sieve in the gastrointestinal tract and entraps digestive enzymes including pancreatic α-amylase and lipase. Consequently, a proportion of the carbohydrate and fat loads ingested will escape metabolic cleavage resulting in a flattened post-prandial elevation of glucose and components of fat, respectively. Since the mode of action is mechanical (physically separating digestive enzymes from food), it is classified as a medical device, class IIb. The patented breakthrough technology SiPore® behind Sigrid Therapeutics is based on 13 years of research and development at the laboratory of physiology Professor Tore Bengtsson at Stockholm University.
About the STAR study
The STAR (Sigrid Therapeutics HbA1c Reduction) study was performed as 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 subject consumed SiPore15® 3 times daily for 12 weeks. The primary endpoint was a reduction in long term blood sugar, as measured by HbA1c, after 12 weeks of treatment with SiPore15®. Link to the published article in Nanomedince here: https://www.futuremedicine.com/doi/10.2217/nnm-2021-0235
Details of the STAR (Sigrid Therapeutics HbA1c Reduction), which involved 40 patients at two sites, one in Sweden, the other in Finland, can also be found at www.clinicaltrials.gov/ct2/show/NCT03823027 and https://www.sigridthx.com.
About Sigrid Therapeutics
Sigrid Therapeutics (Sigrid) is a clinical-stage healthtech company driven by the vision that no one should fall sick with chronic lifestyle diseases. The Company’s lead product SiPore15® is a patented silica-based powder clinically proven to lower long-term blood sugar and a range of metabolic parameters. Designed to act locally in the gut SiPore15® consists of precisely engineered micron-sized silica particles with tailored porosity capable of entrapping digestive enzymes inside the gut, lowering calorie uptake. To read more about Sigrid, visit www.sigridthx.com.
1Kanat M, Defronzo RA, Abdul-Ghani MA. Treatment of prediabetes. World J. Diabetes 6(12), 1207-1222 (2015).
2Supported by studies conducted by Maruther 2013 (DPP), ADA prediabetics 3000 pts, O´Brien et al 2015 and Aroda 2016 (DPPOS)
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