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Carbiotix uppdaterar i väntan på GRAS-godkännande

Carbiotix uppdaterar i väntan på GRAS-godkännande

Carbiotix uppdaterar i väntan på GRAS-godkännande

20 oktober, 2022

Efter ett intensivt nyhetsflöde under våren, har det varit tystare från prebiotika-bolaget Carbiotix under sommaren och inledningen av hösten. Nyligen uppdaterade dock bolaget om en rad viktiga aktiviteter som man bedrivit under tiden. BioStock kontaktade vd Kristofer Cook för att få veta mer kring produktionsplanerna, den regulatoriska godkännandeprocessen och lanseringen av bolagets produkt CarbiAXOS.

Spotlight-noterade Carbiotix utvecklar och tillverkar nästa generation prebiotiska modulatorer, CarbiAXOS, som kan användas som ingrediens i livsmedel, kosttillskott, medicinsk mat och i terapeutiska behandlingar. Prebiotiska fibrer ger en bättre maghälsa och kan förebygga sjukdomar genom att ge föda åt goda bakterier i tarmen.

Smart prebiotics

I början av juni tog Carbiotix in 16 Mkr i en företrädesemission och strax därefter invigde vd Kristofer Cook bolagets första storskaliga produktionsenhet av CarbiAXOS i Bjuv. Sedan dess har man fokuserat på att optimera tillverkningsprocesserna inför den stundande lanseringen. Läs mer.

Carbiotix har även utvecklat LinkGut, en B2B-tjänst som är riktad till bolag som vill erbjuda sina användare en laboratoriebaserad analys av hälsotillståndet i magen. I kombination med CarbioAXOS utgör LinkGut ett koncept som Carbiotix kallar för Smart Prebiotics, som erbjuder både en avancerad bevakning av tarmhälsan och nästa generations prebiotiska fibrer som är upp till tio gånger mer effektiva än första generationen.

Aktiviteter i väntan på GRAS-godkännande

För att kunna lansera CarbiAXOS som ingrediens i livsmedel i USA, krävs ett godkännande av en expertpanel och bolaget väntar på ett s.k. GRAS-SA-besked (Generally Regarded As Safe – Self Affirmation).

Carbiotix meddelade nyligen att tidsplanen blivit förskjuten p.g.a. att ett viktigt enzym från tredje part som används i tillverkningen, fick GRAS-godkännande först i september. I ursprungsplanen skulle Carbiotix GRAS-SA-process för CarbiAXOS vara klar i slutet av oktober, men blir nu alltså något försenad. Enligt bolaget ska detta inte påverka den planerade lanseringen i november.

Under tiden har Carbiotix sett över sin patentportfölj och överväger att överge två konsumentinriktade patentansökningar för att styra de finansiella resurserna till ansökningsprocesser som rör modulatorerna.

I väntan på GRAS-beskedet har bolaget även fokuserat på att optimera sina tillverkningsprocesser och utvärdera sina uppskalningsalternativ för att kunna möta efterfrågan på de nya prebiotiska modulatorerna som man förväntar sig.

Carbiotix uppdaterar om planerna

BioStock kontaktade vd Kristofer Cook för att få höra mer om bolagets senaste aktiviteter och om planerna framöver.

Kristofer, the third-party enzyme was GRAS approved in September – what does this mean for your own GRAS-SA process?

– As I mentioned, the GRAS approval of our third-party enzyme is a prerequisite for the approval of our GRAS dossier. The logic is quite simple, we cannot use an enzyme in our process that is not considered safe for human consumption. Unfortunately, this process has taken time and has been out of our hands and in fact out of the hands of the third-party as they submitted a No-Objection dossier, which unlike our Self Affirmation dossier, is reviewed by the FDA. Thus, we have been forced to simply wait until this approved status came through.

– We have however used this time to improve our product and process, so this is not wasted time. Now we are moving forward with our own GRAS process with an improved product. Given that all parties involved in the dossier, as well as the expert panel, have been waiting to move forward, my hope is that this process can be completed quite quickly and without issue.

– At this time, I however prefer not to specify a time-period for this approval so as to avoid creating false expectations. It should be noted, we have every incentive to complete this process as soon as possible as it will allow us to start generating sales revenues with the reassurance of selling a safe product.

What effect does this have on your planned launch together with FibreHigh in November?

Kristofer Cook, vd Carbiotix
Kristofer Cook, vd Carbiotix

– The fact that we are still committed to launching CarbiAXOS in November is testimony of our confidence of its approval in a timely manner. This is in part a function of where we are in the GRAS Self Affirmation process and our confidence in the product we have developed. Thus, we feel very comfortable at this stage to ramp up pre-sale activities and scheduling the provision of samples for efficacy and formulation testing as a parallel activity before CarbiAXOS reaches GRAS Self Affirmation status. This was not the case until our third-party enzyme was GRAS approved.

– Regarding the co-launch with FibreHigh, the regulatory delay and further product development activities have meant a delay to this launch. We are currently evaluating a new plan going forward taking into consideration current market developments and the planned activities of both companies. This, however, does not impact our ability to sell CarbiAXOS to other nutraceutical companies given the right of first refusal structure of our agreement.

In your latest press release, you mentioned that you are looking into the possibility to use a contract manufacturer for CarbiAXOS – is this alternative more feasible than building your own capacity?

– I noted several arguments in support of utilising a contract manufacturer in our latest press release. Probably the most convincing arguments relate to our ability to quickly scale-up our process using the existing production capacity held by others, the ability to avoid investments in the short-term and an ability to create a buffer and back-up for our own capacity expansion.

– Many large food and beverage companies use and have used contract manufacturers for precisely these reasons, so why diverge from this core strategy? For us, the margins of the CarbiAXOS nutraceutical product should quite easily allow for it, so why not adopt this same strategy?

– Moreover, by working with other producers we will be able to accelerate our learning curve and become better manufacturers and sooner. Since we are initially targeting sales in the US, it only makes sense from a cost and sustainability standpoint to work with a contract manufacturer in the US. This strategy will not differ in Europe as it is universal.

You also stated that you are exploring new applications with CarbiAXOS, such as skin care. Could you briefly elaborate on this?

– The regulatory delay and decision to explore contract manufacturers also allowed us to begin to explore other applications of CarbiAXOS where we could better utilise our site in Bjuv and where we could come to market sooner.

– Skincare applications of CarbiAXOS are one such opportunity that we are exploring. The logic here is quite simple, your skin or epidermal layer is host to probiotic bacteria that serve to ensure good skin health. Feeding these bacteria with effective prebiotics is very similar to feeding the bacteria in your gut. As you do not consume skincare products, the regulatory requirements are less demanding, thus allowing us to potentially come to market sooner.

Everyone is feeling the macroeconomic headwind with rising interest rates, soaring inflation, geopolitical tension and high energy prices. How has this changed the demand for CarbiAXOS and LinkGut?

– I can say that macroeconomic developments have impacted Carbiotix’s strategy. We started adapting to this already in Q1. For example, our exploration of contract manufacturers as a short -term expansion strategy and products that we can bring to market sooner were a direct response to tightening market liquidity.

– This has also shaped our efforts to accelerate putting in place an integrated product development environment allowing us to quickly broaden our product portfolio, and early efforts to explore upcycling opportunities with third-parties and thus have better control of the cost and reliability of raw materials flows.

– We have not seen any indication that macroeconomic headwinds have impacted the demand for CarbiAXOS and/or LinkGut. Health in general has historically done very well in challenging economic times.

– I assume gut health being a key health trend should also do well in a potential recession. I think the competitiveness of our LinkGut service and the fact that the market has been waiting a long time for an AXOS product, should create beneficial tailwinds. We have also taken the approach of focusing on the complementary features of our products and services in order to target the widest possible customer base.

Finally, there seems to be a lot going on in the company, what do you hope to achieve before year end?

– The completion and operation of our own full-scale production site and development laboratories have allowed us to put in place the key building blocks to accelerate product development activities.

– To be honest, this is what I am most proud of to date, not only because it is difficult, but also as it provides the tools to accelerate innovation in the company. In this regard, further solidifying our innovation culture and continuing to develop CarbiAXOS products from new substrates across modulator classes will be a key activity and value driver in the company not only in Q4 but also going forward.

– Of course, getting GRAS SA in place for CarbiAXOS is self-evident and we will do what we can to accelerate this in Q4 now that the product development, scale-up and regulatory prerequisites are aligned. As there are many other parallel activities in Q4, I encourage readers to review our most recent press release to get an update and overview of where we are heading.

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