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Mesoporous silica particles

Sigrid Therapeutics’ SiPore15 prevents weight gain in mice

SiPore15 is currently being investigated in a clinical trial called STAR01

Sigrid Therapeutics has announced the publication of a major study in mice demonstrating the enzyme-blocking effects of mesoporous silica particles (MSPs) introduced to the gut and the resulting effect on food efficiency and metabolic risk factors. Sigrid has previously performed clinical studies demonstrating that SiPore15 lowers blood sugar levels, measured as HbA1c.

The company’s lead product candidate, SiPore15 (class IIb medical device), is an orally-administered medical device for the safe reduction of blood sugar levels in people at risk of developing diabetes, prediabetics and newly diagnosed type 2 diabetics. The device is a tasteless and odourless white powder taken with water. A First in Man clinical trial of SiPore15 showed significant reductions in a range of metabolic parameters and an excellent safety profile.

SiPore15 is currently being investigated in a clinical trial called STAR01. The primary objective of STAR01 is to evaluate the performance and safety of SiPore15 after a 12-week long treatment in the target population of subjects with obesity and who are overweight with prediabetes or newly diagnosed type 2 diabetes. The expected performance and safety of the device is based on the safety and efficacy results seen in the earlier FIM study.

The safety and tolerability of SiPore15 is based on the well-established and extensive use of food grade silicon dioxide and favourable FIM data. Data on side-effects will be collected for verification of device safety. The study duration is 24 weeks in total, 12 weeks from baseline on investigational medicinal device (IMD) treatment, with additional 12 weeks off treatment. The study population is planned for forty (40) subjects to be enrolled, male and females, age >18 years and fulfilling all inclusion criteria but none of the exclusion criteria.

“We designed an innovative approach,” said Professor Tore Bengtsson at the Department of Molecular Biosciences, The Wenner-Gren Institute, Stockholm University, Sweden, and the one heading the research team behind the study. “Mesoporous silica particles are a type of ingestible synthetic silica particles that can be produced with a large surface area and a range of pore sizes.”

The team hypothesised that the particles could be used as “molecular traps” in the intestine to trap and block digestive enzymes that break down food and thus reduce the energy uptake into the body (measured as food efficiency).

“The data presented in this study suggest that tailored MSPs could be used to treat obesity and diabetes in humans, especially when taking into account their excellent safety profiles”, added Bengtsson.

In the study, ‘Mesoporous Silica with Precisely Controlled Pores Reduces Food Efficiency and Suppresses Weight Gain in Mice’, reported in Nanomedicine, mice were fed high fat, high calorific diets, to induce weight gain, mixed with specially engineered MSPs. The results showed that MSPs reduced food efficiency by 33 per cent leading to a lower weight gain, and a positive effect on the metabolic profile, as well as significant lower levels of adipose tissue formation and leptin, together with lower levels of circulating insulin.

“These results are very exciting and open up for new possibilities of SiPore15 to be used for weight control and weight loss besides blood sugar control, rending us a powerful new tool in the fight against diabetes and obesity,” said Sana Alajmovic, CEO, Sigrid Therapeutics.

Sigrid Therapeutics has previously reported the first results from their Proof of Concept STAR study in subjects with prediabetes and newly diagnosed type 2 diabetes, which revealed a 1.4mmol/mol mean reduction in HbA1c, a key marker of blood sugar control (p=0.0391). SiPore15 also 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 with 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 levels in patients in need of novel and safer solutions for prevention of type 2 diabetes.” explained Professor Kirsi Pietiläinen, Coordinating Investigator in the STAR study.

“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 prediabetes patients by the American Diabetes Association. Importantly, SiPore15 was well tolerated, which is a significant competitive advantage over systemically acting drugs.” added Alajmovic. “The 12 weeks follow up period of the study is 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.”

The full results will be submitted for publication in a peer-reviewed medical journal and presented at a scientific conference.

To access the Nanomedicine paper, please click here

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