David Chiswell, CEO of Nabriva tells us more about their latest positive phase II results

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Video title: David Chiswell, CEO of Nabriva tells us more about their latest positive phase II results
Released on: June 22, 2011. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, Fintan Walton talks to David Chiswell, CEO of Nabriva
Areas of focus and types of molecules developed
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here in Oxford, England. On this show I have David Chiswell, who is a CEO of a company called Nabriva, based in Vienna, Austria. Welcome to the show.
David Chiswell:
Thank you.
Fintan Walton:
David, could you tell us a little bit about Nabriva itself, how it's funded and the type of molecules you are developing?
David Chiswell:
Nabriva was a spin out from Sandoz, Novartis back in 2006, and in Sandoz they had a company referred for a number of years have been researching new antibiotic classes and as Sandoz became more of a generic company this company found was spun out into Nabriva and Nabriva was funded by venture capital consortium which was lead by Phase4 Ventures and The Wellcome Trust, Global Life Science Ventures, and HBM and also a little bit from the Novartis Venture Fund themselves.
Fintan Walton:
Okay so you are well funded, could you tell us little bit more about the specific field that you are focused on, the therapeutic areas you are focused on and the types of molecules you are developing?
David Chiswell:
Yes, we are focused on pleuromutilins and this is a novel class of antibiotics which principally hits the bacteria that cause skin infections, pneumonia's and the various sorts as well as other indications like TB . So the pleuromutilins have been around for a number of years, but haven't successfully transitioned into man and there is no systemic pleuromutilins approved for use in man, the advantage is that pleuromutilins is a class is that because they have a different mode of action to many antibiotics they are not affected by the resistance mechanism, so for example some of them are prevalent bacteria are resistant so we have multi-drug resistance pneumococcus which cause pneumonia , then we have MRSA which causes the majority of skin infections, serious skin infections in the US and many European countries, so there is a real need to have antibiotics which really attack these resistant bacteria and that's for that reason we focused very much on the pleuromutilins and we wanted to get an antibiotic which we could deliver both intravenously and orally to patients with infected skin and pneumonia , skin infections and pneumonia's .
BC-3781 and phase II results
Fintan Walton:
And in terms of the products that you are currently developing in Phase II could you tell us more about that particular product?
David Chiswell:
Yes it was actually discovered after we spun out of Sandoz, but relying on this sort of many years of experience that the team here had in developing these class of antibiotics and it was chosen because it was more metabolically stable, it has other good characteristics and then we knew that we could give it systemically or we believe we could give it systemically and the pleuromutilins are in general you make them pretty much like a resilience in the old days that there is a core which comes from a fungus and they you add-on side chains and such side chains expertise that we have developed and it was a particular characteristic of this we call it actually BC 3781 which encourages to take it forward into man.
Fintan Walton:
Okay you've just recently put out a press release about the results that you've got in Phase II, could you tell us little bit more about those results?
David Chiswell:
Yes, I can. Well first of all in antibiotics you have to test your drug against an active comparator because obviously if someone has a infection you know that they need to be treated with an antibiotic so we don't do placebo control trials in these field, so we compared our pleuromutilin against vancomycin which is the market leader in patients treated in skin infections and we choose skin infections as our lead indication to test here. So we tested in the US all our studies were done in the US we recruited 210 patients they were randomized into two doses of 3781 and all of vancomycin the standard dosage and then they were followed they were treated for 5 to 10 days and then followed thereafter to see that their infection had been cured. When we look at the results we see that vancomycin as we expected in this population is a pretty effective drug and that generally it cure rate in the 85 to 90% range depending on the measure we used and also that both dosage 3781 were at least equivalent to vancomycin with also cure rate in the 85 to 90% range. So from an efficacy point of view the drug wasn't you have shown that it is comparable to vancomycin. I think the key with antibiotics is you have just the efficacy go with any side effects you need to be concerned about and one of the encouraging things about this study is that the they were relatively small numbers of adverse events in the study and in fact numerically we had few adverse events on both arms of 3781 that occurred in the vancomycin arm, so we on the basis of the Phase II results we believe that we've now have the proof of concept for the first time that a pleuromutilin can be delivered intravenously into man with a significant infection and to cure it and also that it's important that the adverse event profile was also relatively (indiscernable) which actually confirms what we found in our Phase I studies, so we are now really encouraged now to get moving and start thinking about our Phase III profile and commercializing this drug.
BC-3781 position against established products like Vancomycin
Fintan Walton:
So how do you see a product being positioned against an established product like vancomycin?
David Chiswell:
Well the antibiotic market is quite complex, because you have an interesting mixture of generics by vancomycin and branded drugs like zyvox, cubicin, and although the generics are not only cheap and are used in the majority of cases, the branded drugs have advantages such that they can get good sales, so for example linezolid, sorry zyvox is selling for around about US $1 billion worldwide and cubicin is selling for around about US $600 million just principally in the US, so you can make so these drugs can make money in these area, where we see 3781 positioned is for example in both skin and community-acquired pneumonia it would be positioned as the drug of choice to give when patients coming with serious infections and you could, for example in pneumonia we believe it is the only drug where you could say if the patients comes in with severe pneumonia such as they need to be hospitalized you should you can consider giving 3781 as the only drug to that patient, with vancomycin for example you have to give other drugs to catch bacteria which vancomycin doesn't attack. So in pneumonia vast majority of pneumonia's community-acquired pneumonia's are caused by pneumococcal there is a significant number maybe 25, 30% are caused by other bacteria which are lumped into the in a typical class and drugs like vancomycin and zyvox do not attack those bacteria were as actually 3781 does. So we believe that this treatment as a monotherapy for significant community-acquired pneumonia and also for significant skin disease is the positioning of 3781.
Fintan Walton:
Presumably then this product can be used in frontline therapy?
David Chiswell:
Yes that's true, I think it's worth recalling that in our Phase II clinical study around 70% of the infections are caused by MRSA the resistant bacteria, so the resistant bacteria is here now and we need to be able to treat it now.
Fintan Walton:
David Chiswell, thank you very much indeed for coming on the show.
David Chiswell:
Thank you Fintan.
Fintan Walton
Dr Fintan Walton is the Founder and CEO of PharmaVentures . After completing his doctoral research on the genetics of cell proliferation at the University of Michigan(US)and Trinity College (Dublin, Ireland), Dr Walton gained broad commercial experience in biotechnology in management positions at Bass and Celltech plc (1982-1992).
David Chiswell
David Chiswell joined Nabriva Therapeutics in March 2009 as Chief Executive Officer. After a career as a research scientist in both the UK and the US and nine years working in scientific management at Amersham International, David Chiswell was co-founder of Cambridge Antibody Technology (CAT in 1990. He was responsible for operational management from 1990 to 2002 including as CEO from 1996 to 2002. CAT listed on the London Stock exchange in April 1997 and Nasdaq in June 2001. Since leaving CAT in March 2002 David Chiswell has been focusing on the development of early stage biotechnology companies including positions as non-executive Chairman of Sosei Ltd, Arrow Therapeutics Ltd, and Daniolabs Ltd and as a director of Arakis Ltd. David Chiswell is currently Executive Chairman of Albireo Ltd and is an advisor to Nomura Phase4 Ventures. David Chiswell is a past Chairman of the UK's BioIndustry association (BIA) and remains on their board. In 2006 he was awarded the OBE by HM Queen for services to the biotechnology industry.
PharmaVentures is a corporate finance and transactions advisory firm that has served hundreds of clients worldwide in relation to their strategic deal making in the pharmaceutical, life science and healthcare sectors. Our key offerings include: Transactions / deal negotiations; Product / technology valuations; Deal term advice; Due diligence & expert reports; Strategy formulation; Alliance management; and Expert opinion for litigation/arbitration cases. PharmaVentures provides the global expertise to ensure our clients generate the highest possible return on investment from all their deal making activities. We have experience of all therapeutic areas and can offer advice on both product and technology commercialisation.
Nabriva Therapeutics
Nabriva Therapeutics was founded in February 2006 as a spin-out of Sandoz GmbH. In early 2006, Nabriva raised Euro 42 Million in a Series A Financing Round from a group of top level international life science investors led by Nomura Phase4 Ventures. The Company's current shareholders are Phase4 Ventures, HBM Partners, The Wellcome Trust, Global Life Science Ventures, Novartis Venture Fund and Sandoz GmbH. The same group of investors invested a further Euro 15m in October 2009.