Apr 03, 2020, 13:00
Carbiotix (publ) ("Carbiotix") announces today that Lund University, working with Skåne University Hospital, has been granted funding to conduct a four-month clinical study of 100 type-2 diabetes patients during Q2 2021 using Carbiotix AXOS medical food as a co-treatment to the drug metformin. The results of this study will, according to the Board's assessment, provide key clinical data for regulatory approvals in the US and Europe and evidence for a potential commercial launch of a metformin medical food co-treatment product targeting diabetes patients in early 2022.
There are currently over 400 million people globally diagnosed with type-2 diabetes, with over 120 million people who have been prescribed metformin as a therapeutic. This makes metformin one of the most prescribed drugs for type-2 diabetes in the world. Unfortunately, the negative gastrointestinal side effects of using metformin, which include diarrhea and flatulence, have resulted in low adherence to the therapeutic, resulting in greater complications and higher overall costs. The current study funded by Vinnova through their SweLife and Medtech4Health call aims to significantly improve the clinical care of type-2 diabetes patients by demonstrating the efficacy of Carbiotix AXOS medical food as an effective co-treatment with metformin that can address gut dysbiosis by improving overall gut health. (1)(2)
The study will be a four-month single-blinded parallel randomised controlled trial of 100 people aged 55-70. During four months, participants will consume daily 10g of AXOS or maltodextrin (control). Clinical data and fecal samples will be collected at the start, at 2 and 4 months. The patients will also fill in a quality of life questionnaire at these time points. In between scheduled visits, there will be telephone contact with all the patients to check their health and well-being. Blood samples will be analysed for haematological parameters, glucose, insulin, blood lipids, vitamin B12 and markers of low-grade inflammation. Intestinal microbial community analysis will be performed by high-throughput next generation sequencing of 16S rRNA amplicons and quantitative PCR.
Kristofer Cook, CEO for Carbiotix, comments
"I am extremely pleased by this news and look forward to working closely with Lund University to ensure a successful outcome. This study falls perfectly within our plans to first launch a medical food in the indication areas we are targeting and then a therapeutic product, which will allow us to accelerate our time to market and significantly reduce the risk of failure all together with regards to our therapeutic candidates. Since the global market for medical foods exceeds 15 Billion Euros, with margins similar to therapeutics, and the market for type-2 diabetes therapeutics is valued at over 45 Billion Euros, targeting a type-2 diabetes medical food makes perfect sense, especially given the role gut health plays in patient adherence to metformin." (3)(4)
Lieselotte Cloetens, Biomedical Nutrition, Pure and Applied Biochemistry at LTH, Lund University, comments
"The incidents of metabolic diseases such as diabetes are high and thus it is important to have more effective treatment and care for these patients. Metformin is used as a standard treatment, but it often leads to gastrointestinal symptoms caused by negative changes in gut bacteria (intestinal dysbiosis) and therefore unfortunately many diabetic patients end up with the standard treatment. Arabinoxylan oligosaccharides (AXOS) are a prebiotic product that advantageously affect the activity and composition of the gut bacteria. In our project, we will conduct an intervention study with a new AXOS product to test whether intake of AXOS together with metformin in diabetic patients can contribute to better bowel health and care."
This information is information that Carbiotix AB is obliged to make public according to the EU Market Abuse Regulation (MAR). The information was made publicly available by the company's contact person set out below on 3 April 2020.
For further information:
Kristofer Cook, CEO
Carbiotix AB (CRBX) (www.carbiotix.com) is an award-winning biotechnology company pioneering microbiome healthcare through a range of cost-effective gut health testing services and a portfolio of microbiome modulators covering prebiotic ingredients, medical foods and therapeutics.Go Back