Phase 2 Development of BIT225 for HIV Treatment [transcript][audio]

Guest: Dr. Michelle Miller

Presenter: Tabetha Moreto

Guests Bio: Dr Miller has over 20 years of experience in the bioscience industry, with focus on commercial development of early to mid-stage technologies. She completed her PhD in the Faculty of Medicine at Sydney University investigating molecular models of cancer development. She has worked for several years at Johnson and Johnson developing anti-HIV gene therapeutics through preclinical research to clinical trials. She also has finance industry experience from time spent as an Investment Manager with a specialist bioscience venture capital fund.

Segment overview: Dr Miller talks about Biotron’s current lead compound, BIT225, which is in Phase 2 development for the treatment of HIV-1 & hepatitis C. Biotron Limited (Biotron) is a company that focuses on the development of technology that targets viroporin proteins, which are key to enabling the pathogenicity of a number of viruses including hepatitis C, HIV-1, Dengue, Zika, Influenza and Respiratory Syncytial Virus (RSV).

TRANSCRIPT – Biotron

Tabetha Moreto: Hello everyone, welcome to Health Professional Radio. I’m your host for today Tabetha Moreto. Our guest today is Michelle Miller, the CEO and Managing Director of Biotron. Dr. Miller has worked for over 20 years in the bioscience industry. Today, we’re going to talk about a very interesting topic – Biotron’s drugs target virus proteins which is able to treat diseases such as Hepatitis C, HIV1, dengue, Zika virus, etc. Without further ado, welcome to the show, Michelle. I’m so happy you can join us today.

Michelle Miller: Thank you very much. I’m really delighted to talk to you and to tell your listeners about the exciting work that our company is doing.

T: Yes. Speaking of your company, please tell our audience more information about yourself and your company please.

M: Okay. So my name is Michelle and I’ve been working in the area of HIV in particular for most of my career and have a background in PhD in that. We’ve also worked in the finance industry for a number of years before coming into the biotech company 16 years ago. So Biotron is an Australian biotechnology company. We came out from the Australian National University in Canberra with some ideas of how to treat viruses in a different way, how to attack it in ways that other drugs don’t attack and it means that you can target them in a different way to prevent resistance and to come up with ways you can treat diseases that we’ve not been able to before. So Biotron is primarily focused on HIV as its main target although we also have clinical programs to hepatitis C and other early stage programs against some other viruses. But really, I think what’s the most important one to discuss right now, the one that we’re most excited about is our HIV program.

T: Sounds very fascinating. Now tell us more about this drug that your company has developed?

M: So our drug has a very exciting name which is BIT225 and the reason it’s 225 is that it’s the 225th compound that we made. We came up with the idea of how to target HIV in a different way. This is from what we came out from very exciting research from our Founder’s laboratory at the John Curtin School back in the late 1990s. So things have taken a long time to develop and we have been designing drugs which would attack the virus in particular reservoir cells to HIV and then take that drug that we designed through various preliminary testing before you can put it in humans and then taking it through clinical trial to the stage where we are now in the dispatch complete of phase 2 clinical trial. So I guess just to give people maybe some background about the indication and about why HIV matters is the reality is AIDS rather is no longer a public health issue. And so while AIDS is no longer an issue, HIV still continues. In Australia, each year there’s about a thousand new cases and there’s a bit of complacency I think in particular in young people who probably don’t remember the dreadful problems with HIV and AIDS since 1980s and early 1990s. This is more complex these days and the numbers in young people, our concern I guess, it’s also the other problem is that certainly in 2015, a quarter of the new HIV cases in Australia where people have been infected for more than 4 years. So there’s still some way to go in terms of making sure people don’t become infected. The other reason why we’re interested in HIV is because the reason why we are so interested in HIV is because of the possibility of eradicating this virus. It used to be thought that you can keep patients long term on existing antiretroviral drugs which works very well at keeping … the disease in check. We can now keep patients alive, really to determine actual life with the current existing drugs. But the reality is that the virus is still present in those patients. You take a patient whose long term infected but been on drugs, the virus is below the level of detection and yet as soon as you stop giving drugs to those patients, the virus rebounds. So the virus is always there in those patients. And the reason why that is a problem is we’re starting to get, because of diseases and problems in patients having that virus always there at low levels kicking along. We get issues with age-related dementia, now known more commonly as HAND or HIV-Associated Neurocognitive Dysfunctions, there are issues with immune ageing and senescence. Those are now problems with drug like interactions – ageing population, people needing to take other drugs, having to take this quite a cocktail of antiretroviral drugs can limit the prospects of treatment for other diseases they may get as they get older due to interactions with other drugs and of course, the cost. We don’t say this for any other disease as well, we’ll keep you on drugs forever. The reality is let’s try to eradicate the virus and that’s really the space that Biotron is working in with its drugs.

T: That’s a very fascinating information. Now can you tell us why is this particular topic relevant especially to health professionals?

M: The reason why this is most relevant to health care professionals is we’re coming up with ways to eradicate a problem in population that is now ageing. Patients who are long-term infected on these drugs can have issues with age related dementia, with their immune ageing, with the issues with the interactions with other drugs. So there is a way to actually get rid of the underlying virus, then you can improve the health outcome in those patients and their immune and virus that is going forward means that the issues associated with that won’t be there anymore. And in addition, there will be of course the cost benefit from being able to either stop or at least reduce these expensive treatments.

T: That’s interesting. Now tell me what is the biggest misconception about the drug that you have developed that drives you crazy and it keeps you up at night?

M: There’s a couple of things. But one of the key ones is people often say, “Well, this is HIV. The problem is over. Isn’t this fixed?” The reality is that it’s not. They’ll still going to say that – people, a thousand new infections every year in Australia, worldwide, over 2 million new infections every year. So the fact that it hasn’t gone away, the problem is for their age is no longer a problem because we can treat patients but the virus is still there. It is still being transmitted. The other thing that really drives me crazy is the misconception about translational research and how long that can take. We see breakthroughs published or reported in the newspapers and on TV regularly that some researcher at the universities come up with a groundbreaking discovery. And people then expect great, this is going to be available to them next year. The reality is a scientist at the university coming up with an idea, it then takes over a decade or 15 years or more to take that concept from that earlier idea to designing a drug, to taking it to early testing, to performing clinical trial and it costs a lot of money to that process. And it’s not sexy, it’s not interesting to people, it’s not breakthrough all the time. It’s solid work that takes it through from a discovery, exciting in the newspaper phase through to having a product that can be sold and benefit patients. I think lack of understanding of that process is really one of the things that I would like to change.

T: Thank you very much for clearing up those misconceptions today. I agree with you that HIV and AIDS is something that a lot of people are afraid of especially you mentioned back in the 1980s and 90s this was something that was really feared but luckily nowadays, because as technology advanced, as time went on, now people understand that HIV may still be there but maybe sooner or later, there’ll be a treatment or a cure for it.

M: Well that’s what we’d hope. It certainly is no longer a death sentence and I think there’s a really fantastic work that scientists and doctors around the world have achieved to get to this point. So let’s try to get to the next stage where we could actually eradicate it for good.

T: Excellent. So now Michelle, can you tell us how can people get in touch with you?

M: So the best way to get in touch with us is via email and our email is [email protected] And also on our website which is biotron.com.au

T: Thank you very much, Michelle. Now before we end the program, what is your main takeaway message to all of our audience out there?

M: I think my main takeaway message will be that viruses are part of our lives. We need new drugs which will help prevent some of these outbreaks, for example with Influenza, with Zika, we’ve seen SARS outbreaks in the past. These viruses aren’t going away. We need to come up with great ways to be able to eradicate them before they get us.

T: Very well said Michelle. Thank you so much for your message. I really appreciate you coming on the show today.

M: Thank you very much.

T: And that was Dr. Michelle Miller, CEO and Managing Director of Biotron. We’ve just been talking about Biotron’s drugs target virus proteins that can help treat viral diseases such as HIV. If you like this interview, transcripts and archives are available at www.hpr.fm. We’re on all social media platforms so don’t forget to follow, like and subscribe. We’re also available for download on SoundCloud and iTunes. I’m Tabetha Moreto and you’re listening to Health Professional Radio.

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