Our goal with SiPore21® is to provide an accessible, non-pharmaceutical solution for blood sugar control, empowering millions of individuals worldwide to manage their metabolic health proactively. The high patient interest and remarkably low dropout rate of 6% in the SHINE trial underscore the strong demand for innovative, patient-friendly treatments in this space. Large-scale diabetes studies show that even a modest reduction in HbA1c could delay type 2 diabetes onset by several years, significantly improving public health and reducing healthcare costs globally.
I am delighted to report that enrollment for SHINE has been completed. We observed excellent patient compliance and a very low dropout rate during our visits to the clinics. Importantly, no dropouts were initiated by the investigators themselves. We are on track to complete the study in October and report initial results by year-end. SiPore21® represents a user-friendly, natural approach to blood sugar control and weight management, establishing a pivotal role in the expansive arsenal required for effective diabetes prevention and enhancing global health outcomes.
In the ongoing search for sustainable treatments for sustainable blood sugar and weight management, we believe SiPore21® answers many questions on safety, efficacy, and sustainability. According to a major sector report by Siftel, SiPore21® was highlighted as one of the most promising over-the-counter weight management products. As we reach this milestone of completing patient enrolment in SHINE, Sigrid is actively engaged in discussions with global industry leaders who have shown strong interest in bringing SiPore21® to market. We are swiftly advancing negotiations to commercialize SiPore21® as a medical device in the EU and as a medical food in the US. The opportunity to partner with us in this groundbreaking venture is time sensitive as we move towards product launch.
Patient-friendly, safe, and without negative effects on lean body mass, SiPore® technology could offer a much-needed non-pharmaceutical alternative to injectable drugs for sustainable blood sugar and weight management. Reuters recently reported that the majority of patients discontinue injectable treatments within two years, primarily due to cost and side effects. SiPore21® could address these concerns and help prevent the common weight regain that follows stopping such treatments.
Having seen the technology, scientific portfolio and safety data, it was clear that the potential oral and systemic health benefits of SiPore® are tangible and could be field changing – perhaps the biggest innovation since fluoride!
Caries and periodontitis are among the most prevalent noncommunicable diseases globally, affecting approximately 3.5 billion people. Any method to improve oral health will have significant impacts on individuals and health economics within society. As a dentist, I see great potential for SiPore®, once it becomes commercially available, to become an important tool for both consumers and professionals in enhancing oral health
We’ve had incredible interest in SiPore® and its potential use in oral health right from the beginning. Both from leading experts and oral health companies. I am proud of our achievements and based on our ongoing discussions with global partners, I believe it is realistic to have the first SiPore®-fortified products on the market by the end of 2025.
The study is making good progress and we are grateful to the clinics for the quality of their work. During our visits to the clinics, we observed excellent patient compliance, accompanied by an exceptionally low dropout rate. Crucially, the safety of the study is underscored by the fact that none of the dropouts were initiated by the investigators themselves.We now look forward to including the remaining patients and to completing the study after the summer. SiPore21® represents a user-friendly, natural approach to blood sugar control and obesity management, establishing a pivotal role in the expansive arsenal required for effective diabetes prevention and enhancing global health outcomes.
As SHINE trial results approach, Sigrid is actively engaged in discussions with numerous global industry leaders, demonstrating strong interest in bringing the SiPore21® product to market. With momentum building, Sigrid is swiftly advancing negotiations to commercialize SiPore21® as a medical device in the EU and as a medical food in the US. The opportunity to partner with us in this groundbreaking venture is time-sensitive, as we move swiftly towards product launch.
The SiPore® technology offers a unique non-pharmaceutical alternative to injectable drugs for sustainable blood sugar management, curbs hunger sensations, and reduces bloating. We are excited about the prospect of SiPore21® being a gentler and safer way of achieving sustainable weight control without negative side effects on lean body mass. For patients who discontinue treatment with injectable drugs, SiPore21® could be a way to safeguard against the common weight regain that follows after stopping such treatments.
With SiPore®’s clinical development for obesity and blood sugar control advancing at a rapid pace and funding secured in our recent over-subscribed round, we are ready to accelerate commercialization. After an extensive search, we have identified Cencora as a partner who understands fully our expectations and will be able to help us fulfil our ambition to introduce one of the most important innovations in obesity and diabetes treatment.
“As a leading provider of clinical and commercialization services, we partner with pharmaceutical and biotech companies to help them accelerate product development and efficiently bring products to global markets. We’re thrilled to support Sigrid Therapeutics’ pre-commercial launch preparations as the company moves toward a potential launch in the United States and Europe.
This is a remarkable leap forward in our company’s initiative to continue to present ourselves throughout the U.S. market and empower those seeking to live healthier and more well-rounded lives. Pure Pharmacy’s emphasis on individualized care that empowers its customers to take control of their health is a direct reflection of our own goals and are thrilled to have partnered with them.
We strive at Pure Pharmacy to deliver the most premium prescription and over-the-counter options and are so excited our pharmacy is the exclusive Miami retailer to provide customers with the Glucose Stabiliser.. The company’s dedication to years of research and innovation with its SiPore® technology is truly the driving force behind our decision.”
The Glucose Stabiliser is representative of Sigrid’s mission of empowering those looking to transform their metabolism for the better in an affordable and approachable manner. After seeing my father transition from having difficulty controlling his blood sugar to developing Type 2 Diabetes, it is a personal undertaking just as much as it is professional, to develop innovative treatments that allow users to continue living their life to the fullest, without having to drastically change their lifestyle.
This funding will propel our efforts in establishing key partnerships and driving SiPore® technology to market. We are thrilled to have the backing of our investors as we move closer to providing effective solutions for obesity and diabetes management.
Sigrid's continued success is evident from the launch of one of the world's largest prediabetes trial, SHINE, to SiPore21®'s medical device classification and the commercial traction in our oral health vertical. These accomplishments show the company is well on track to deliver on its exciting potential.
We're pleased that Sigrid Therapeutics' recent share offering was oversubscribed by an impressive 50%. In today's challenging financial climate, this achievement underscores the company's quality and potential. Amidst concerns about obesity and diabetes, the demand for effective, non-drug therapies is evident. This success mirrors investor confidence and Sigrid's commitment to pioneering drug-free solutions.
In the realm of prediabetes management, there's a significant unmet medical need for accessible and user-friendly tools. SiPore21® has the potential to fill this gap effectively. Its innovative approach aligns with the demand for non-pharmaceutical solutions that empower individuals to take control of their health. SiPore21® addresses this critical need, offering hope in the fight against the growing prediabetes epidemic.
At Sigrid, we are entering an exciting phase of development with the launch of the SHINE clinical trial for SiPore21®. Our innovative technology represents a user-friendly, natural approach to blood sugar control and obesity management, setting it apart from modern-day diabetes and obesity pharmaceuticals. We truly believe SiPore21® is going to make a positive impact on the healthcare landscape by preventing diabetes and improving human health worldwide.
This was a very easy decision, having seen the technology, scientific portfolio and safety data, it was clear that the potential oral and systemic health benefits of SiPore® are tangible and could be field changing. I was particularly drawn by the physical rather than chemical mode of action of the technology, its flexibility and broad functionality, which could significantly impact the oral as well as the gut microbiome in a positive manner. Taken together the arguments for significant health benefits are compelling and there is some exciting science to be done.
Through my own research into diabetes, I knew of the connection between bad metabolic health and bad oral health. We are therefore excited to work with Iain and his team to explore the possibility of using our technology to help lessen the burden of sugars in the mouth and improve both related conditions.
By effectively removing amylase, SiPore® decreases the availability of sugar and restricts the growth of pathogenic bacteria and the formation of dental biofilm and plaque. Therefore, as a dentist myself, I believe SiPore® could be one of the biggest innovations in preventative oral health since fluoride. However, in recent years Professor Chapple and others have already shown the links between poor oral health and other systemic metabolic diseases. Which opens even wider potential applications for SiPore®.
There is a very strong link between bad metabolic health and bad oral health, and this is a reason why we looked into this direction. We are excited by the possibility of our technology to help lessen the burden of sugars in the mouth and improve oral health.
As a dentist, I believe SiPore® could be one of the biggest innovations in preventative oral health since fluoride and a game changer in the oral care industry. By effectively removing amylase, SiPore® decreases the availability of sugar and restricts the growth of pathogenic bacteria and the formation of dental biofilm and plaque. SiPore® is compatible with fluoride, but unlike fluoride it exerts its effect before the tooth has started to demineralize. Already we have attracted a great deal of interest among European dental professionals and KOL’s and IDS gives us now the opportunity to introduce SiPore® to the global oral health community. We are interested in collaborating with established oral care companies that seek to co-develop, commercialize, and bring our intellectual property and technology to market successfully
Along with diabetes and obesity, right from the beginning, we identified the oral health market in particular as a major opportunity. Over 3.5 billion people worldwide suffer from oral caries and periodontal disease and with poor nutrition a growing problem, this number will only increase. SiPore® is a truly innovative technology that can make a real difference.
Although we have seen clinically significant effects of the SiPore® technology in previous clinical trials including a 40% larger HbA1c reduction compared to Metformin in prediabetics*, the overwhelmingly positive, subjective ratings from the users exceeded our expectations.
Even more inspired to move forward in our development, we are now preparing to launch SiPore® as 1) a dietary supplement for the US market, 2) a veterinary products, primarily for cats and 3) within oral health. In parallel, we are advancing the SiPore® technology as medical device in the EU and are set to start a large clinical study in 287 patients who are either overweight or obese and suffering from prediabetes or type 2 diabetes.
The structure and function of Mesoporous silica can be tailored for a plethora of application areas, including diabetes and obesity. The present results explicitly show that these particles stay intact after having passed through the gastrointestinal tract. The concept that these particles are working locally with no systemic absorption together with the excellent safety and efficacy shown previously in studies in both animals and patients makes us very encouraged to further exploring the clinical usage of these marvelous little particles
In the current climate, the rapid completion and oversubscription of this new fund raise is a sign of confidence in both SiPore´s® huge potential and our commercialization strategy. In addition to our core prediabetes market, we have identified three major areas which can bring cashflow to the company in the near future – dietary supplements, veterinary products for cats and oral health - with these funds we can now implement our plans for each.
Sigrid has continued to move forward at a high pace. A capsule product has been developed, the consumer pre-launch program is completed, and preparations for the world’s second largest commercial pre-diabetes study SHINE are coming to a close.