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Clinical Trial

Sigrid Therapeutics Initiates the Clinical Trial STAR of SiPore15

By February 5, 2019 No Comments

Sigrid Therapeutics AB Initiates a Clinical Trial of SiPore15™ for Treatment of Prediabetes with Engagement from Crown CRO

Stockholm, February 5th 2019 – Sigrid Therapeutics AB (Sigrid) and Crown CRO (Crown) today announced the initiation of the STAR clinical trial, testing the efficacy and safety of the orally-administered medical device SiPore15™. The goal of this clinical trial is to demonstrate an improvement in cardio-metabolic risk factors in patients with prediabetes and newly diagnosed untreated type 2 diabetes.

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. Information for potential participants in the study can be found at www.clinicaltrials.gov/ct2/show/NCT03823027and https://www.sigridthx.com

Sana Alajmovic, Co-Founder & CEO of Sigrid Therapeutics, states: “Prediabetes is a serious medical condition characterized by elevated blood sugar levels which not only increases the risk of developing type 2 diabetes but also getting a heart attack and stroke. 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. We are excited to work with our partner Crown which has shown great commitment to executing according to set project timelines and quality standards.”

Tarja Leikas, CEO of Crown CRO, further noted: “We are honoured to have been selected by Sigrid Therapeutics to help oversee this very important trial. The prevalence of prediabetes is increasing worldwide, and it is projected that over 470 million people will have prediabetes in 2030. Given the prevalence of this serious medical condition and the promising therapeutic profile of SiPore15™, we expect to be able to leverage our geographic expertise, especially within Scandinavia to rapidly enrol patients while effectively managing costs and timelines.”

About Sigrid Therapeutics AB
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.

 

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