Innovative new study to compare the health impact of Velo modern oral nicotine pouches to smoking

•  New study designed to identify differences in important early indicators associated with smoking-related disease between Velo users and smokers
•  Results will provide important new data and insights about Velo and its role in facilitating tobacco harm reduction
•  Demonstrates BAT’s focus on science and innovation to deliver A Better Tomorrow™ and reduce the health impact of its business
   

BAT has conducted an innovative cross-sectional clinical study of Veloⁱ, which is designed to provide new insights into the real-world health impact of its modern oral nicotine pouch product compared to smoking. Protocol details explaining the design have been published in the journal JMIR Research Protocols .

The study evaluates exposure to certain toxicants and early indicators associated with smoking-related disease in people who have been exclusively using Velo for over six months and compares them with groups of smokers, former smokers, and never-smokers.

The biomarkers selected are important indicators that include:

•  Biomarkers of Exposure: a person’s exposure to certain toxicants or chemicalsⁱⁱ
•  Biomarkers of Potential Harm: indicators of potential harm related to several smoking-related diseases, such as respiratory or cardiovascular disease
   

It is hoped that the results, which are currently being analysed and will be published by the end of the year, will provide further supportive evidence that using Velo may reduce relative risk for certain diseases among adult consumers compared to smoking. These data would add to the growing body of evidence demonstrating Velo’s potential as a reduced-risk product.^*†

Dr Sharon Goodall, BAT’s Group Head of Regulatory Sciences, said: “Modern oral nicotine pouches are an exciting product category, which build upon the extensive scientific evidence available for snus, but are designed to offer adult consumers an improved, tobacco-free reduced-risk alternative. We have already generated data that shows Velo has a toxicant profile better than snus and is comparable to Nicotine Replacement Therapy (NRT)ⁱⁱⁱ. However, we wanted to generate further evidence to demonstrate the important contribution it can make to tobacco harm reduction. I believe the results of this study will provide important new information and we look forward to sharing them once available.”

About the study

The study includes participants who have been using Velo exclusively for over six months, as well as current smokers, former smokers and never-smokers. For the Velo users and current cigarette smokers, usage patterns and overall consumption were not controlled whilst in the clinic as the aim was to assess the impact among people using the products in their ‘normal’ way rather than in a controlled manner. Four different groups were enrolled and studied.

These comprised:

1. Current smokers who had been smoking at least 10 cigarettes per day for at least one year prior to screening
2. Exclusive Velo consumers for at least six months
3. Former smokers who had quit for at least six months
4. Never smokers
    

Participants were based in Denmark and Sweden, aged between 19-55 years old, and in good general health.

Unlike longitudinal studies where participants attend multiple clinic visits over an extended period of time, participants in this study made a single clinic visit where samples of blood, urine and breath were collected, and other clinical measurements were performed. These samples and measurements were then assessed for “Biomarkers of Exposure” (to selected toxicants) and “Biomarkers of Potential Harm”. Differences in the biomarker levels between the groups were compared and analysed.

In addition, to ensure compliance with reported product usage, the Velo and former smoker groups were tested for the biomarker, CEVal, and the exploratory biomarkers anatabine and anabasine, to indicate whether or not they had smoked cigarettes during the preceding six months.

Results from the completed study will be published by the end of the year.