Spotlight-noterade Carbiotix avancerar mot att etablera bolagets smarta prebiotics på marknaden. Bolaget meddelar att Lunds universitet har börjat rekrytera patienter till klinisk studie i typ 2-diabetes som prövar CarbiAXOS medicinska mat i kombination med standardbehandlingen metformin. BioStock kontaktade vd Kristofer Cook för att få veta mer.

Läkemedlet metformin är ett av de mest förskrivna läkemedlen för mer än 400 miljoner människor i världen som är diagnosticerade med typ 2-diabetes. Läs mer.

Användningen av metformin orsakar dessvärre negativa biverkningar i magen, till exempel diarré och gasbildning, vilket medför att patienterna i stor utsträckning avbryter behandlingen.

Medicinsk mat för god tarmhälsa

För att överbrygga detta problem aviserar Lunds universitet nu en ny klinisk studie som syftar till att minska biverkningarna med metformin, genom att använda foodtech-bolaget Carbiotix medicinska mat för att förbättra den generella tarmhälsan och motverka tarmdysbios.

Carbiotix utvecklar nästa generation prebiotiska fiber för en mer hälsosam tarmmiljö. Bolagets modulator CarbiAXOS används som ingrediens i livsmedel, drycker och kosttillskott för att främja en god tarmhälsa, och kommer nu att testas i medicinska behandlingar.

Klinisk prövning inleds i Q2

Bolaget meddelar nu att CarbiotixAXOS ska ingå i en klinisk prövning som medicinsk mat för att sambehandla typ 2-diabetes med metformin. Studien kommer innefatta 100 patienter i åldern 50-80 år, och genomförs av Lunds universitet och Skånes universitetssjukhus mellan Q2 och Q4 2022. Den aktuella studien finansieras av Vinnova via deras SweLife– och Medtech4Health-program.

Resultaten från studien kommer, enligt bolaget, att ge viktig kliniska data för regulatoriska godkännanden i USA och Europa. Vidare förväntas studien ge bevis för en potentiell kommersiell lansering av en sambehandlingsprodukt med metformin som medicinsk mat för typ 2-diabetespatienter.

BioStock kontaktade vd Kristofer Cook för en kommentar om den kliniska studien och utsikterna för CarbiotixAXOS.

Kristofer, what volumes of CarbioAXOS will be required for the study?

– For the Lund University study, approximately 150 kg of CarbiAXOS medical food will be required. This product will be produced at our soon to be completed production site in Bjuv with additional processing such as filtration and spray drying performed by our local partner. Eventually, our site in Bjuv will be able to fully manufacture CarbiAXOS medical food and therapeutic co-treatment ingredients in a partial GMP facility.

– The good thing about all of our modulator products (i.e. food & beverage and nutraceutical ingredients, and medical food/therapeutic co-interventions) is that they are based on the same process and simply differ in terms of the purity of the CarbiAXOS backbone and downstream processing. This allows us to leverage the same production facility to manufacture multiple modulators (from a wide range to very specific molecular weights). Our site in Bjuv will eventually only be limited by its scale and thus food & beverage ingredient CarbiAXOS will be manufactured in the US and continental Europe to achieve economies of scale and lower manufacturing costs.

What evidence are you expecting from the clinical trial at Lund University?

– The clinical trial at Lund University will investigate whether the intake of medical food grade CarbiAXOS together with metformin can significantly improve glucose metabolism and gut health in patients with type-2 diabetes. Since gut health plays a key role in pharmacokinetics and how much active ingredient in a (pro)drug reaches the liver, improving gut health is not only important for pharmaceuticals such as metformin but many other drugs used to treat leading diseases.

»The clinical trial at Lund University will investigate whether the intake of medical food grade CarbiAXOS together with metformin can significantly improve glucose metabolism and gut health in patients with type-2 diabetes.«

– In the case of metformin, the drug induces gut dysbiosis in many patients and thus addressing gut health through the elevated consumption of an efficacious prebiotic medical food should improve both drug side effects and the efficacy of the drug. For us, this will be a first study that will provide empirical data to support the use of CarbiAXOS as a medical food to be used in conjunction with metformin.

What requirements does CarbiAXOS need to fulfil in order to be approved as medical food?

– Although medical foods are intended for use under the supervision of a physician, they are still classified as food products and thus for example the FDA does not need to approve a medical food. In Europe however, like a new ingredient requiring novel foods approval, EFSA needs to approve a medical food designated as Foods for Special Medical Purposes (FSMPs). In both cases, one however needs to demonstrate safety, good manufacturing practices, registration of a food facility, and that a product qualifies as a medical food. Since a medical food is to be used for the dietary management of a disease or health condition that requires special nutrient needs, one needs to demonstrate the nutrient needs of each health condition and how they will be met.

– Moreover, one needs to demonstrate that the medical food provides an effect that cannot simply be achieved through the modification of the normal diet. Thus, we will need to collect evidence through studies such as the Lund University clinical trial to argue that CarbiAXOS qualifies as a medical food. If we are unsuccessful in doing this, we always have a fall-back strategy and can market CarbiAXOS as a high-end nutraceutical to be used in the management of different health conditions and biomarkers. Thus, I see no case where we will not bring a product to market either as a medical food or high-end nutraceutical, especially given the potential purity and bifidogenic effect that can be achieved with medical food grade CarbiAXOS.

»I see no case where we will not bring a product to market either as a medical food or high-end nutraceutical«

Looking ahead, what is the market potential for CarbiotixAXOS as medical food?

– This study will thus serve as a foundation for future studies targeting diabetes as well as other leading disease areas where there are drugs at market or under development. Given that 90 per cent of the adult population suffers from a lack of soluble fibre or prebiotics in their diet and thus their gut health could be improved, the potential impact of our medical food can be very significant.

– Since the market for medical foods exceeds 15 billion USD globally and is growing at 7 per cent per annum, there is certainly market share that can be taken through a novel approach such as ours where we are also able to validate efficacy through our companion diagnostic service LinkGut both in studies and under real life conditions. Moreover, our diagnostic platform will play a key role in helping us qualify CarbiAXOS as a co-intervention medical food for different disease areas by demonstrating the extent of nutritional deficiencies in patients and the need for and impact of prebiotic medical food supplementation on gut health.

Se även Kristofer Cooks presentation av Carbiotix vid BioStock Investor Meeting i mars 2022.

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