Aker Biomarine gets NDI nod from FDA for brain health ingredient

10-Aug-2023 - Last updated on 10-Aug-2023 at 14:49 GMT

Courtesy of Aker BioMarine

The Norwegian fishing and biotech company has successfully achieved New Dietary Ingredient (NDI) status from the US Food and Drug Administration for its Lysoveta. Under the NDI, Aker BioMarine can market Lysoveta at 1.5 grams/day for the general adult population.

Aker Bio has spent the last several years developing and building the clinical substantiation for Lysoveta, a novel dietary supplement for targeted delivery of lysophosphatidylcholine (LPC-EPA/DHA) derived from krill.

“I mean we started this project back in 2014, so it's been several years of development, probably some $50 million of investment in developing a production process and then doing all the safety studies and now preparing for the commercialization of the product, so it’s quite exciting,” commented Matts Johansen, CEO, Aker BioMarine ASA.

The company, which develops krill-based ingredients for nutraceutical, aquaculture, and animal feed applications, has a supply chain that stretches from krill harvesting in Antarctic waters through its logistics hub in Montevideo, Uruguay, to its krill oil manufacturing facility in Houston, Texas.

Blood brain barrier

Aker Bio plans for supplement firms to use its EPA/DHA innovation bound by lysophosphatidylcholine to allow the fatty acids to pass through the blood-brain and blood-retinal barriers to boost eye and brain health benefits.

“We’ve known for quite some time that the EPA and DHA omega-3s are important for the development of the brain. And there's correlations between the amount of EPA and DHA in the brain to different types of mental disorders – could be depression, could be ADHD, Parkinson's, Alzheimer and so on,” explained Johansen.

“So in 2014, a molecule was discovered that basically transports omega-3 across the blood brain barrier and that transport is called LPC, lysophosphatidylcholine.”

The LPC transport is critical for providing LPC as building blocks for the formation of neurons and regulation of membrane phospholipid composition. The transporter is also present in other vital organs beyond the brain, highlighting the wide-ranging potential for beneficial effects of dietary LPC.

Johansen added that LPC-bound EPA/DHA has not been made widely available, until now.

“You can only make this in the laboratory. It costs like two and a half thousand dollars per gram, but in krill, the omega-3 phospholipid molecule, you can just alter that molecule a bit and then turn it into one of these LPC molecules. And that's what it is and what we have been doing– developing those production processes in our factory in Houston and building out the manufacturing processes there. So we’re ready to start making commercial products and then doing all the safety and all the things you need to do to get approval in place, which we just got. Now we're going to start to bring it to market and add on more clinical trials to document the benefits.”

Claim substantiation

Johansen told us that memory is a clear claim that they will go after, as well as improved uptake in the brain.

In the next 12 months, Aker plans to publish more clinical data as well as endpoint studies in humans to get claims on memory and other types of brain-related endpoints.

“But then the interesting part is that this transporter is also needed in some of the other organs, like in the kidneys, in the placenta for reproduction, in the bone marrow, so it's different places in the body where this has an interesting effect and there's some new data that just came in now that looked at both effects on liver and on kidneys with quite interesting data,” said Johansen. “So I think our first focus will be on memory and or let's call it mental performance, and then I think after that we might look into some of the other organs where this transporter also has an effect, for instance, in liver health.”

While there have been ongoing dialogues with potential partners, Johansen said now that Aker BioMarine received the NDI nod from the FDA, they are ready to kick things into high gear.

“Up until now it's been an R&D program about product development and animal data and safety data and all that, and now we're moving into the commercial phase. So now this is when we start to invite the partners on board to see if they want to join us on this journey and see if we can replicate the success we've had the last 10 years in the brain health segment.”