In another Science lab presentation, Dr Chris Junker (BAT) shows the latest scientific findings on oral nicotine pouches and discusses how nicotine pouches can advance tobacco harm reduction.
Transcription:
00:06 - 00:13
[Giselle Baker]
And this one, again, is going to be a slightly different format. So Chris has got a slide deck here, and he's going to present it live.
00:14 - 07:12
[Chris Junker]
Okay. Thank you, Giselle. Hi, everyone. Glad to be here. I'm going to spend a bit of time talking about what we see as the next frontier in tobacco harm reduction with oral nicotine pouches. We'll see if this works. Ah, perfect. So a bit in terms of what I plan to cover, this is very much a whistle stop tour of the data we've generated on oral nicotine pouches over the last few years. But I think it builds on some of the earlier discussion in the first science lab and perhaps fills in a few more gaps that hopefully prompts a good discussion. So if you look at these products at a very fundamental level, I would say they're very simple in many ways. In terms of use, obviously, placed in the mouth, nicotine flavors absorbed through the oral mucosa. From a compositional perspective, there's a cellulosic substrate, nicotine flavors, humectants wrapped in a porous fleece material. And then if you look at the broader chemical composition, substantially less complex than traditional smokeless tobacco products and far less complex than combustible cigarette smoke. We've looked at that toxicant profile versus both combustible cigarettes and traditional snus, and what you see here are greater than 99% reductions versus a reference cigarette and 42 to 92% reduction versus snus. On the right is a more holistic comparison of Oral nicotine deliveries, so on the right you have NRT, and what you see is nicotine pouches are very similar from a toxicant profile to NRT, much simpler than snus, and on the left here is an example from traditional smokeless products in Southeast Asia, so a drastic increase in the toxicant profile of those products versus any of the other categories. If you look at the toxicological profile in cell-based assays, these are two of several we've done. So the left is looking at cytotoxicity. Again, we see a much lower response for nicotine pouches versus snus and substantially reduced versus combustible cigarette smoke. On the right is an assay looking at several markers of genotoxicity. And again, what we see are you know, lower responses for oral nicotine pouches versus reference snus. And if cigarette smoke was on here, it would all be positive, obviously. If you look at human use of these products, we've looked at use behaviors in several ways. The one on the left here is around average daily consumption. And in the studies we run, we see comparable levels of use per day versus traditional snus products. The middle box is around use topography, in this instance, mouth hold time, so how long a consumer keeps the pouch in their mouth. And we've observed lower times for these products versus traditional snus. And on the right is nicotine exposure, which this is yielding use data. So essentially measuring the content of nicotine analytically before and after use of a pouch to determine how much is extracted. And here we see comparable to lower levels of nicotine extraction versus traditional snus. Moving on to nicotine exposure, we've done pharmacokinetic studies. This is actually a compilation of two studies looking at combustible cigarettes, traditional oral tobacco snus, and oral nicotine pouches. And the pharmacokinetic profile for nicotine pouches looks very similar to traditional snus and, as you would expect, very different than combustible cigarette exposure. If you look at biomarker data, this is data from a cross-sectional study that we have run. So this is a group of exclusive nicotine pouch users, a group of exclusive smokers, and a group of former smokers. And we measured on the left biomarkers of toxicant exposure. And for the nicotine pouch group, we saw significant reductions versus the smoker cohort. and levels of reduction that are very much similar to those who are former smokers. On the right, we have biomarkers of potential harm, which are markers mechanistically linked to smoking-related diseases. And again, in several cases, we saw statistically significant decreases versus the smoker cohort, and in some cases, comparable reductions versus those who were former smokers. And so now just a bit of a pivot to pull in the Swedish experience, which I know everyone in this room knows very well, so I won't go into a lot of detail, but obviously Sweden's an excellent example of tobacco harm reduction and the potential of these smokeless products, you know, 5.4% smoking rate, you know, substantially lower mortality rates than the rest of the EU. The epidemiology showing much lower risk for oral cancer and many other smoking-related diseases. And the right is really just, you know, the aspirational piece in terms of if this was extrapolated to the rest of Europe, what the potential opportunity is. And I bring that up really just to note that we, you know, the data we've generated on nicotine pouches is not only our weight of evidence approach to support the reduced risk potential of our products in this category. I also think it provides helpful links into the epidemiology. If you look at toxicant exposure versus snooze, if you look at consumer use behaviors versus snooze, if you look at biomarker reductions versus former smokers or smokers and former smokers, to me it all helps tie together this potential of oral nicotine pouches in terms of comparable or perhaps better population level health outcomes versus what we have seen in Sweden. OK, so with that, I'll say thank you and happy to answer any questions.
07:19 - 07:37
[Giselle Baker]
Do we have any questions from the floor? Oh, we have Jeannie again. Or actually, we have a new voice first. Oh, no, that's also. Well, we have the same people. We're going to look for another voice. We got one first. We'll come to you guys, though.
07:38 - 07:56
[Attendee]
Yeah, so you mentioned nicotine user-only groups. I wondered what kind of size control groups you're looking at for these experiments, how you're finding that they're nicotine pouch-only users, are they previous smokers, and how do you get an accurate stratified sample of users across age groups and ethnicities? That's a very good question.
07:56 - 08:42
[Chris Junker]
I can't recall the cohort size for each of those groups in the study in terms of you know, essentially verification of their use status, um, that there was biochem biochemical verification. So for former smokers, uh, you know, we've done some work on, uh, a biomarker called CVAL. Um, so it was, you know, verifies long-term abstinence, uh, for the velo, uh, or the nicotine pouch group, we looked at some minor alkaloids to verify that they were not dual using, uh, with smokeless tobacco as well. In terms of the demographics across the groups, I don't recall that information, but we can certainly, I can certainly point you to the publication that shows all that information.
08:44 - 09:33
[Jeannie Cameron]
My question relates to your slide on the pharmacokinetic curve and the difference between cigarettes and oral snus and nicotine pouches. Do you think the spike that is shown on the curve relating to cigarettes and the difference, that's the most significant difference that can be seen, does that have any behavioural relevance or whatever relevance, scientific relevance to addiction? Because do you think that people who, that sort of, it's the addiction to that spike or that curve or that hit of nicotine could be part of the reason why there's less addiction to oral where the curve is, the delivery is in a different way, as it were?
09:34 - 10:07
[Chris Junker]
Yeah, so I certainly think there are aspects of that curve that play into nicotine. some of those behavioral pieces. I will say we've also done combination PK abuse liability studies for, largely for regulatory purposes in the US. And when you look at those subjective measures, you do see a correlation in terms of a sharp decrease in urge to smoke or elements of product satisfaction. So I do think there's something to what you're saying.
10:11 - 10:56
[Attendee]
Thanks, Chris. Really comprehensive data. Thanks for the presentation. I have a question on the used topography. So coming from a consumer perspective, you were showing that comparing to loose snooze, comparing to snooze, oral nicotine pouches are left in the mouth by the consumer way shorter. So do you have any insights of why that is the case? Is it because that's what is printed on the pack or is it because it's less satisfying to the consumer? Do you have any ideas of the reason behind that slightly different topography and time using the product?
10:57 - 11:37
[Chris Junker]
Yeah, it's a very good question. I think there are probably elements of the longevity of the product and what you're extracting from it. I will say this is data from one group and one population. We've looked at those use behaviors across a number of different geographies, and it is very different. I think if you were to look at nicotine pouch topography in the Nordics, It's longer. If you look at it in the US, it's probably shorter. So it's highly variable based off of the population and the products that are in that market.
11:47 - 12:02
[Attendee]
So a bit of a follow-up to that last question. I was just wondering, were you using comparable strength snus products to nicotine pouches in terms of their nicotine content? And what range of strength of nicotine snus and nicotine pouches were you looking at as part of this trial?
12:05 - 12:09
[Chris Junker]
Another good question, and I can also point you to that publication as well.
12:11 - 12:23
[Jeannie Cameron]
Do you think flavor... I mean, I take it out, but the flavor's finished. And maybe with the tobacco ones, the flavor doesn't finish. I don't know.
12:25 - 12:46
[Chris Junker]
I've never used a tobacco one. Yeah, I mean, anecdotal evidence for me, but I think that has to play a part in terms of the longevity of the product. And you're right. I think in many cases, nicotine pouches stop delivering flavor much faster than traditional oral products. So that could certainly be a part of what plays into the behavioral.
12:49 - 12:53
[Giselle Baker]
Turns out human behaviors are complex. Yes.