Mar 24, 2021, 08:45
Carbiotix (publ) ("Carbiotix") announces today that the company will begin a comprehensive evaluation of a new enzyme in Q2 supplied by a potential strategic partner. This new enzyme has the potential to accelerate achieving FDA GRAS No Objection and EFSA Novel Foods status in the US and EU respectively for AXOS food ingredients, supplements and our planned medical foods however will shift the time plan of our ongoing GRAS Self Affirmation process for AXOS.
Kristofer Cook, CEO for Carbiotix, comments
"We have recently become aware of a new enzyme in the pre-launch phase that, after an initial evaluation in Q1 of 2021, we have determined has the potential to accelerate achieving FDA GRAS No Objection and EFSA Novel Foods status in the US and EU respectively for AXOS food ingredients, supplements and planned medical foods, which would have taken longer with the registration and approval of our own enzyme. Therefore, properly evaluating and preparing to include this enzyme in all regulatory filings, including our current GRAS Self Affirmation dossier to ensure product consistency, will likely put us in a much better position to accelerate our time to market and fulfil subsequent regulatory approvals. This will save time and money over the long run and allow us to meet more stringent regulatory requirements posed by larger potential customers. Moreover, the supplier of this enzyme is a leader in their respective industry thus creating more reliability in our supply chain. This new enzyme belongs to the same family as our own enzyme and is used to hydrolyse pre-treated corn bran to extract AXOS and falls within scope of Carbiotix patent for producing a corn bran extract containing the AXOS prebiotic.
Consequently, in this instance we have decided to accept a shift in the time plan of our ongoing GRAS Self Affirmation process for AXOS which we had originally planned to complete by this time. While this shift in the time plan has naturally a short-term impact, it is the correct decision to make to ensure that our GRAS Self Affirmation dossier reflects the use of this new promising enzyme. We will also need to push forward the completion of our first pilot site to the second half of 2021 to ensure that our process reflects the use of this new enzyme and its impact on pre-treatment and downstream processing steps.
For the timing being, we will not provide any defined timeframe for the completion of the first GRAS Self Affirmation process for AXOS as we are dependent on third parties, however we will do our best to ensure this process is completed as soon as possible and in-line with the completion of our first pilot site. I truly believe that pursuing this new enzyme will save both time and money, place Carbiotix in a much stronger strategic position going forward and create potential collaboration opportunities across multiple business areas with a global player also committed to B2B microbiome health solutions."
This 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 24 March 2021.
This communication contains forward-looking statements, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their nature, as is research and development work in the biotechnology segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios as described in this press release.
For further information:
Kristofer Cook, CEO
Tel: +46 (0)708-796580
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