Avitop Obtains US and EU authorisation for nutraceutical CorriX and announces product launch
GRAS/Novel Food status allows for accelerated product development and commercialisation in the United States and Europe
Avitop, a Berlin-based biotech company developing next generation nutraceuticals, has announced that the company has obtained European Novel Food authorisation from the European Commission for CorriX, a nutraceutical containing the company's proprietary strain Bacteroides xylanisolvens DSM 23964 under Regulation (EC) No. 258/97 of the European Parliament and of the Council.
Recently, the US Food and Drug Administration (FDA) granted (letter of no objection) B. xylanisolvens DSM 23964 and heat-treated milk products fermented with this strain 'Generally Recognised as Safe' (GRAS) status for use in dairy and other food applications (GRAS Notice No. GRN 000457).
Based, in part, on the GRAS status, Avitop then determined that B. xylanisolvens DSM 23964 is appropriate for use as a dietary ingredient in the company's new line of CorriX supplements.
'Achieving GRAS and Novel Food status is a major milestone for Avitop and allows for accelerated product development and commercialisation both in the United States and Europe,' said Dr Philippe Ulsemer, Director of Avitop GmbH.
'Numerous studies have shown that micro-organisms naturally inhabiting our body are crucially involved in our health and well-being. We are fully committed to use our know-how, technologies and ingenuity to develop new probiotic, nutraceutical and food concepts with unmet functionality to provide customers with a new generation of functional food that will help to manage health and well-being from the inside-out.'
Potential unique health benefits of Bacteroides xylanisolvens DSM 23964
Avitop invests significant resources in scientific research to investigate the potential health benefit of B. xylanisolvens DSM 23964, a new strain that was primarily characterised in 2012 (Applied and Environment. Microbiology 78, 528-535 [2012]).
Avitop recently identified this strain to carry the 'Thomsen-Friedenreich antigen' (TF) on its surface. Strains carrying this antigen were reported to be able to induce the development of specific antibodies (IgMs) directed against the TF-antigen in vivo and a higher level of such natural TF-antibodies in humans were reported to benefit the natural function of the immune system.
As a consequence, Avitop believes that the regular consumption of a product containing the strain B. xylanisolvens DSM 23964 will support the development of natural TF-antibodies, thereby providing significant health benefits. Avitop is currently running human studies to investigate this assumption.
