Reig Jofre is working to gain European Food Safety Authority (EFSA) novel food classification for the supplement known as Nyaditum resae, which, its creators claim, acts by suppressing the body’s immune response to tuberculosis, helping to prevent carriers of the disease from suffering an outbreak.
The main evidence for these claims is currently a research paper (PDF) presented at the World Conference on Tuberculosis and Lung Health last year. If approved as a novel food, the supplement will be marketed at doctors, to be used as part of a potential TB-prevention regimen.
Reig Jofre also claims Nyaditum resae can help prevent TB outbreaks in vulnerable groups, such as type 2 diabetics, and previous TB sufferers, and offers the possibility of an intervention with fewer side-effects than existing pharmaceutical treatments, making it more suitable for at-risk groups.
“The target group will be people who have been in contact with a TB patient and whom at present are not prescribed the standard six-month antibiotic treatment, mainly due to the adverse effects of such a long treatment with antibiotics, specially to population above 45 years old. Today this group is not offered any treatment to reduce the risk of developing TB,” said Marta Español, head of regulatory affairs at Reig Jofre.
“Additional targets in a second stage would be those people who have travelled to high-risk countries, those who are already infected and must start an immunosuppressive treatment and at a further stage, as a combination with the antibiotic treatment,” she added.
Manremyc has also signed a deal with Tablets India to produce the supplement for the Indian market, with sales expected to start next year. In Europe, Reig Jofre expects to complete the regulatory process and offer Nyaditum resae for sale in Europe by 2017, with production of the supplement in its own facilities.
More trials to come
“To complete the dossier, currently on-going stability studies must be finalised and some standard pre-clinical trials will be carried out, such as Ames test and somatic cell genotoxicity. The product will finally get prepared for production and marketing,” said Español.
In terms of positioning Nyaditum resae to doctors, she said: “It will be marketed on an standalone basis, although practitioners may well recommend it together with the antibiotic treatment. Nyaditum resae reduces the risk to develop TB on its own, but we do not disregard that it may be given in combination with the antibiotic treatment to reduce the risk in those cases where the patient does not finalise the standard treatment.”
Worldwide, around 100 million people become infected with TB, leading to 9 million new outbreaks, and 1.5 million deaths. In Europe, 1.5 million people are carriers of the disease, with 70,000 new infections and 2,000 deaths a year.
Reig Jofre CEO Ignasi Biosca said: “It is essential that from the consolidated pharmaceutical companies, we support research centres and biotechnological start-ups for the complex and costly process that involves technology transfer to society and that we contribute to the important mission of developing solutions not only for the control of diseases but also for its prevention, as here tuberculosis.”