Stockholm, January 28th 2019 – Sigrid Therapeutics AB (Sigrid) and Crown CRO (Crown) today announced the initiation of the STAR clinical trial testing the efficacy and safety ofthe orally administered medical device, SiPore15™. The goal of this clinical trial is to demonstrate an improvement in measurements of metabolic disorder 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 Finland. Information for potential participants in the studycan be found at www.clinicaltrials .gov and 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 type 2 diabetes but also 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 treatment available for reduction of blood sugar levels in people at risk of developing type 2 diabetes.
About Crown CRO
Crown CRO is a privately-owned Finnish contract research organization founded in 2005. Crown CRO provides full services in clinical operations, data services, pharmacovigilance, quality assurance, regulatory and medical affairs, translation services, as well as early development consulting to the pharmaceutical, biotechnology, functional food and medical device sectors, as well as to other contract research organizations.. We have been involved in over 900 clinical studies in more than 18 countries in various therapeutic areas and in all phases of clinical development, with our portfolio currently consisting of over 100 active clinical trials. Our vast experience enables us to serve our customers in coordinating trials from early development phases up to late phase and post-marketing studies with high quality data and on time delivery within budget.
Prediabetes occurs when there is there is impaired fasting glucose, impaired glucose tolerance, or raised HbA1c, in which blood glucose concentrations are higher than normal, but lower than those defining diabetes.1 Studies have shown that over 70% of people with prediabetes will eventually develop diabetes. Prediabetes has been associated with an increased risk of cardiovascular disease. The health risk might be increased in people with a fasting glucose concentration as low as 5.6 mmol/L or HbA1c of 39 mmol/mol.According to WHO, diabetes caused 1.5 million deaths in 2012. Prediabetes caused additional 2.2 million deaths, by increasing the risks of cardiovascular and other diseases. Forty-three percent of these 3.7 million deaths occur before the age of 70 years. The percentage of deaths attributable to prediabetes or diabetes that occurs prior to age 70 is higher in low- and middle-income countries than in high-income countries. The cornerstone of prediabetes treatment today is lifestyle intervention. Intensive lifestyle intervention has been shown to delay or prevent development of diabetes in placebo-controlled trials. Despite the success of lifestyle intervention in clinical trials, majority of people fail at implementing a healthier lifestyle in a real-world setting. Prevalence of prediabetes is increasing worldwide, and experts have projected that more than 470 million people will have prediabetes by 2030. In the US alone, it is predicted that the societal cost of prediabetes will reach $44 billion by 2030. The largest risk factors for prediabetes are being over 45 years of age and being overweight/obese.
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