The Swedish clinical-stage biotech company Sigrid Therapeutics has, together with Crown CRO, announced the initiation of the STAR clinical trial, testing the efficacy and safety of the orally-administered medical device, SiPore15.
The goal of the trial is to demonstrate an improvement in measurements of metabolic disorder in patients with prediabetes and newly diagnosed untreated type 2 diabetes.
40 patients at two clinical sites
Regulatory authorities have approved the clinical protocol for the 24-week STAR (Sigrid Therapeutics HbA1c Reduction) trial, with 40 patients at two clinical sites, one in Sweden and one in Finland.
“There are currently no approved therapies for treatment of prediabetes. SiPore15 is an orally-administered medical device for the safe reduction of blood sugar levels in prediabetics. We anticipate this trial will demonstrate SiPore15’s therapeutic potential to support its continued clinical advancement towards regulatory approval as the first and only orally ingested medical device for the treatment of prediabetes,” states Sana Alajmovic, Co-Founder and CEO of Sigrid Therapeutics.
Alajmovic also reveals that 30 percent of the patients already has been successfully recruited.
About Sigrid Therapeutics
Sigrid Therapeutics was founded in 2014 by Professor Tore Bengtsson and Ms. Sana Alajmovic, with the vision of transforming the way we prevent and treat our modern day chronic lifestyle diseases. The company’s research dates back to 2008 when Bengtsson and his research group at the Department of Molecular Biosciences at Stockholm University made discoveries relating to improvements in measurements of metabolic disorders after oral ingestion of engineered silica particles. The company has since then developed a novel materials platform technology, SiPore, which targets lifestyle diseases by changing the way our bodies digest food. The lead product candidate, SiPore15, is being developed as the first therapy acting in the gut to improve blood sugar levels in people at risk of developing diabetes. The company is part of the Karolinska Innovations incubator Drive for promising life science startups in Sweden.
Photo of STAR Investigators meeting: Sigrid Therapeutics