News & Press
Life Sciences Scotland News - Issue 48
Clinical Development Success for NovaBiotics
Aberdeen based NovaBiotics has successfully completed the dosing phase and initial analyses of its Phase IIa clinical trial for its lead product Novexatin® - a brush on treatment for fungal nail infection.
In the Phase IIa study, 48 patients have been dosed daily on one infected toe nail with Novexatin® over a 28 day period. The results thus far have been very encouraging.
The study remains blinded until all follow-ups are complete, but one third of the patient group is on placebo control while the remaining subjects are active drug candidates. This rate of indicative mycological cure after only one month of treatment is higher than has been reported for existing remedies. Importantly, there is no evidence of any of the potentially serious side effects reported for those treatments, most notably liver damage.
To read the article in full click here
NovaBiotics to attend PepTalk 2010 in San Diego
Dr Deborah O'Neil is scheduled to present Novexatin® as a unique, nail-penetrating compound at the engineering peptides session.
NovaBiotics prepares to out-licence nail product
Novabiotics, the Scottish biotechnology company focused on the design and development of antifungal and antibacterial therapies, successfully completed the dosing initial analysis of its phase IIa clinical trials for Novexatin, a brush-on treatment for fungal nail infection.
Novexatin has been proven so far to rapidly clear fungal nail infection. Nail fungus is estimated to affect around 12% of the world’s population and equates to a total global market worth of around $5 billion.
Dr Deborah O’Neil, the company’s founder, said: “This study confirmed what we anticipated. Novexatin is a unique product that can address the global market of fungal nail infection, which is poorly served at the moment. As such, Novexatin has the potential to access a significant proportion of [the] global market.”
She added: “We are now actively in discussions with potential partners to further the clinical development of this product and the availability of this very encouraging data should now enable us to achieve our aim of taking this product to market.”
To read the article in full click here
Initial Phase IIa Clinical Data for Novexatin® supports Positive Phase I Findings:
Presentation at Bio-Europe Conference 2009
Biotechnology company NovaBiotics, which focuses on the design and development of novel peptide antifungal and antibacterial therapeutics, confirms that the first patients enrolled in its Novexatin® Phase IIa clinical trial have successfully completed a 28 day daily application of the novel antifungal compound.
Novexatin® (NP213), a topical (brush-on) treatment for fungal nail infection, is NovaBiotics’ lead product and is currently being tested in 48 patients. The results obtained so far from the current study confirm the positive data gathered from the Phase I trial carried out earlier this year.
Novexatin® (NP213), a topical (brush-on) treatment for fungal nail infection, is NovaBiotics’ lead product and is currently being tested in 48 patients. The results obtained so far from the current study confirm the positive data gathered from the Phase I trial carried out earlier this year.
Novexatin® has proven to be well tolerated, has not been detected in plasma and no adverse reactions have been reported in any of the 48 patients enrolled during the month-long exposure phase of the current phase IIa trial. Microbiological analysis of the patient’s nails is also successfully underway in order to confirm the ability of Novexatin® to penetrate the patient’s nail and clear infection therein. The remaining patients will complete the study shortly and the company expects to announce the data later this year.
As previously stated, the Directors plan to out-license or co-develop Novexatin® to/with an appropriate pharmaceutical or specialty pharma partner for further clinical development. We are pleased to report that those discussions are progressing well. NovaBiotics is also at an advanced stage in the appointment of a financial advisor to advise on the valuation of Novexatin® and NovaBiotics’ other technology assets to support these negotiations.
Dr Deborah O’Neil will be presenting the clinical data obtained thus far at Europe’s largest biotechnology partnering conference, Bio-Europe, in Vienna on 3 November 2009. Dr O’Neil and Professor Andy Porter, non-executive director, are participating in the one-to-one partnering sessions at Bio-Europe and are attending the meeting as part of the delegation led by Scottish Development International.
Dr Deborah O’Neil, Founder, commented: “I am pleased to report that Novexatin® appears to be working as we expected it to, with no safety issues. Clearly, we won’t know absolutely until the full trial is completed but the early indications are that have a treatment which has none of the side effects of existing products.”
NovaBiotics nears licensing deal for topical antifungal candidate
The UK biotechnology company NovaBiotics is shortly to complete a Phase IIa trial of its topical fungal nail infection treatment Novexatin® (NP213).
The data are expected to seal a licensing deal for the product in the early part of next year. NovaBiotics has signed CDAs (confidential disclosure agreements) with various interested parties, "from big pharma to speciality companies", according to its CEO Dr Deborah O'Neil.
Novexatin®, NovaBiotics' lead programme has been generating interest owing to its month-long treatment period, compared with currently available topical treatments which can take up to a year to be effective.
In the ongoing 28-day Phase IIa study, 48 patients with mild to moderate fungal toenail infection are being treated daily with Novexatin® or placebo control. The infection status, general health and appearance of the nails will be assessed immediately after the final application and at various follow-up visits for at least six months.
To read the article in full click here
NovaBiotics Ltd, of Aberdeen UK, said the first patients enrolled in its Phase IIa trial successfully completed a 28-day daily application of Novexatin (NP213), a topical brush-on treatment for fungal nail infection. Results obtained to date confirmed the positive data gathered from the Phase I trial carried out earlier this year. The treatment has been well tolerated, NP213 has not been detected in plasma and no adverse reactions have been reported in any of the 48 patients enrolled during the month-long exposure phase of the current Phase IIa trial. Microbioloical analysis of the patients' nails is under way to confirm the ability of Novexatin to penetrate the nail and clear infection
NovaBiotics a step closer to licensing
NovaBiotics, a biotechnology firm spun out from Aberdeen University yesterday revealed it was at an "advanced stage" in appointing a financial adviser to value its first drug.
Founder Dr. Deborah O'Neil said the drug had completed the [phase IIa] trial with "no safety issues".
To read the article in full click here
Fungus Nailed
Novabiotics, the biotech firm, is on the verge of signing a seven-figure licensing deal for its fungal nail infection treatment Novexatin®.
To read the article in full click here
Taking nature's lead in antimicrobials
Enterprise Scotland Magazine (Winter 2009 Edition)
Katy Shields' article talks about where NovaBiotics started, the current second phase clinical development and the recent injection of grant funding.
The article in full is available here or in the Winter edition of Enterprise Scotland Magazine, page 75.
Bio-Europe 2009 Profiles
NovaBiotics is a clinical stage anti-infectives drug discovery company based in Aberdeen, UK. Their lead product, Novexatin, is a topical treatment for fungal nail infection which is expected to complete phase IIa of clinical evaluation before the end of 2009.
Fungal nail infections affect more than 12% of the world`s population and provide a global market worth approximately $5 billion.
NovaBiotics` product pipeline and technology platform comprise antifungal peptides against potentially life-threatening systemic yeast infections and antibacterial peptides for serious respiratory, systemic, and dermal infections. The company`s Luminaderm range of compounds has applications across consumer healthcare.
To read the article click here
Novexatin® Phase IIa Study Commences
NovaBiotics announces that the phase IIa component of its first-in-man clinical trial to assess the safety, tolerability and pharmacodynamics of its topical fungal nail infection treatment, Novexatin®, is now underway and proceeding well. A number of patients have already been exposed to a number of doses of Novexatin® and will continue to be monitored over the 28-day study period. A single nail of each of the 48 patients with mild-to-moderate fungal toenail infection will be treated daily with Novexatin®, or placebo control, in this month long study in order to confirm the drug's safety and tolerability (as already demonstrated from a single dose during the now complete phase I clinical trial) as well as its ability to penetrate full thickness nail. The infection status, general health and appearance of the nails will be assessed immediately after the final application of Novexatin® (or placebo control) and at various follow-up visits for at least 6 months.
9th September 2009
NovaBiotics Ltd, one of the UK’s leading biotechnology companies focused on the design and development of antifungal and antibacterial therapeutics, announces that its Founder, Dr Deborah O’Neil will present the science behind its lead product, Novexatin® for the first time at the Interscience Conference on Antimicrobial Agents and Chemotherapy (“ICAAC”) in San Francisco, 12th – 16th September 2009. ICAAC is the leading event in the international anti-infectives calendar and a showcase for novel antimicrobial technologies.
Novexatin®, the Company’s brush-on treatment for fungal nail infection has already successfully completed the first phase of its clinical trials. Initial clinical data was very encouraging. Importantly, Novexatin® could not be detected in plasma from any patients up to 16 hours after exposure to the drug and no adverse reactions were reported. Recruitment of patients is underway for a larger trial in which 48 patients will be dosed daily with Novexatin® over a 28 day period.
The Company also announces that it has secured £220,000 of grant funding from the Scottish Government (SMART funding), the Royal Commission for the Exhibition of 1851 and through a Knowledge Transfer Partnership (KTP) in partnership with the University of Aberdeen. The majority of the funding will be used to further the development of Novamycin™ (NP339) for the treatment of life threatening yeast and fungal infections, targeting a significant and very much unmet global market, and further expanding the applications for NovaBiotics’ novel platform technology.
Dr Deborah O’Neil, Founder, commented: “At the moment, our main priority is to complete Novexatin®’s early clinical development and gather the data we need to commercialise this valuable asset. This is progressing well.
“Novexatin® is a unique product, addressing the shortcomings that exist in current remedies for fungal nail infection which have high relapse rates and, in some cases, have serious side effects and toxicity.
“The platform technology on which Novexatin® is based also has other applications. I am delighted that the Government, KTP and Royal Commission are able to support the work we are doing on our existing pipeline so that we can expand our product portfolio further and address this substantial market.”
6th September 2009
Innovate : University of Aberdeen Business Magazine (Summer/Autumn 2009)
Hitting the Nail on the Head
Dr Deborah O’Neil talks to Innovate Magazine about how she took her academic research on to establish NovaBiotics, the development of Novexatin® - NovaBiotics’ first product for the treatment of fungal nail infections currently in clinical trials – and future company plans.
Immunologist Dr Deborah O’Neil is one of a new breed of female scientists. Young, talented and ambitious, she had the skill to identify at an early stage that her academic research could have significant commercial applications in the world outside the laboratory.
“I felt then that this scientific research had real potential and, when I came to Scotland, I realised that there was an entrepreneurial spirit here, providing scientists with an environment to follow ideas through…”
O’Neil is founder of NovaBiotics, a spin-out company from the then Rowett Research Institute (RRI). Established in 2004, it is about to begin clinical trials for its first product – a novel, brush-on treatment for fungal nail infections – Novexatin®.
NovaBiotics – the winner of the Bio-Industry Association Rising Star Award – plans to use the proceeds from out-licensing Novexatin® to further develop its other products in the pipeline. These include candidate treatments for serious bacterial lung infections (including those associated with cystic fibrosis), MRSA and life-threatening bloodstream yeast infections.
“Initially, my ambition was to cure all known infections [using antimicrobial peptides] preferably by Wednesday,” she laughs, “But then I was invited to probably one of the most interesting and certainly memorable meetings of my life.”
To read the article in full click here (PDF)
Press and Journal (01/09/2009 Edition)
Positive Phase 1 Clinical Data for its Nail Fungus Treatment, Novexatin®
NovaBiotics Ltd, one of the UK’s leading biotechnology companies focused on the design and development of antifungal and antibacterial therapeutics, is pleased to announce that it has successfully completed Phase 1 of its two part first in man clinical trials for its lead product, Novexatin® (NP213), a brush-on treatment for fungal nail infection.
Initial clinical data from the trial is very encouraging. This first component of the Berlin-based first-in-man clinical trial assessed the safety, tolerability and pharmacokinetics of a single dose of Novexatin® and also the placebo (delivery vehicle alone) in 12 patients. Importantly, Novexatin® could not be detected in plasma from any patients up to 16 hours after exposure to the drug and no adverse reactions were reported; either in the placebo and Novexatin® treatment group.
A larger Phase IIa trial will now commence in which 48 patients will be dosed daily with Novexatin® over a 28 day period. Recruitment of patients for this trial is almost complete.
Novexatin® has been proven so far to rapidly clear fungal nail infection in NovaBiotics’ nail infection models. Nail fungus affects in excess of 12% of the world’s population and equates to a total global market worth in the order of $5 bn.
As clinical data becomes available, the Directors plan to out-license Novexatin® to an appropriate pharmaceutical or speciality pharma partner to undertake further clinical development. Discussions are currently ongoing with a number of potential partners.
Dr Deborah O’Neil, Founder, commented: “This initial data provides the platform we expected in order for us to move on to assess the safety and pharmacodynamics of Novexatin in the anticipated 28 day daily dosing cycle. It is an important safety milestone and we’re very encouraged”.
For the full article see The Scotsman, The Herald, Young Company Finance, Press and Journal (01/09/2009 Edition)
6th July 2009
Clinical Trials for Firm's Flagship Product Receive Clearance
NovaBiotics has received clearance to commence first-in-man clinical trials of its lead product Novexatin®, a brush-on treatment for nail fungus. With more than one in 10 of the world’s population affected by nail fungus, successful trials will open up a global market worth and estimated £3billion-plus annually.
Dr Deborah O’Neil, founder and chief executive of NovaBiotics said “I am very pleased that we can announce the commencement of clinical activities for Novexatin. We believe we potentially have a world-leading treatment for fungal nail infections which will be more effective, safer and easier to use than any other product currently available. I have spent six years developing Novexatin and am now delighted to be overseeing it through its first clinical trial.”
The regulatory clearance came from Germany, with approvals from the Federal Institute for Drugs and Medical Devices and also the Ethics Commission, paving the way for clinical work to start immediately.
For the full articles see The Scotsman, The Press and Journal, Financial Times and London Stock Exchange
29th May 2009
Birmingham (Atlanta) Business Journal
Scotland Highlights New Partnerships and Cutting-Edge Drug Discovery Research
At this year's BIO International Convention, May 18-21 in Atlanta, Scotland will showcase the commercial success of its research collaborations with global pharmaceutical and biotech companies, as well as major scientific advancements in stem cells, drug discovery, translational medicine, medical technology and preclinical and clinical research.
With representation from more than 30 companies and organizations, including Scottish Enterprise, Scottish Development International and TalentScotland, the Scottish Pavilion at BIO will display exceptional collaboration among industry, academia and government in its life sciences sector. Scotland's internationally-renowned universities, rich talent base and unprecedented scientific legacy make it a natural home to one of the largest and fastest growing life science clusters in Europe, with more than 620 life science organizations and over 31,000 employees.
Earlier this year, Scottish companies and organizations achieved stem cell breakthroughs in synthetic blood and embryonic and iPS (Induced pluripotent stem cells) technology and began stem cell clinical trials for corneal blindness and stroke, further reinforcing Scotland's world-leading position in the use of stem cell-based therapies. At BIO, government-sponsored innovation fund ITI Life Sciences and stem cell company Cellartis AB will offer insights into the company's new license to produce large volumes of high-quality, ethically-derived human embryonic stem cell lines (hES) and expand Scottish operations. NovaBiotics, one of Scotland's leading biotech companies focused on the design and development of antifungal and antibacterial therapeutics, will also be on hand to discuss the development of its lead product Novexatin®, a novel treatment for fungal nail infection.
For the full articles see PR Newswire and Birmingham (Atlanta) Business Journal
28th March 2009
Aberdeen life sciences firm NovaBiotics is potentially just weeks away from clinical trials of its flagship product after £1.5million of new funding, its chief executive revealed yesterday.
Deborah O’Neil said nearly five years of research and development were about to reach a key milestone towards an innovative, brush-on treatment for nail fungus.
Successful trials of the patented Novexatin technology will open up a global market worth an estimated £3.5billion annually, with more than one in 10 of the world’s population said to be afflicted by nail fungus.
NovaBiotics’ directors believe their anti-fungal technology can easily be adapted for even larger markets, for example the treatment of cystic fibrosis and MRSA. The firm is, subject to the required regulatory approval, now on the verge of putting the product to the test and it hopes to move towards full commercialisation later this year.
The Craibstone-based firm, a spin-out from research done at Aberdeen’s Rowett Institute, has benefited from about £5million in funding since it was established in 2004. A total of £1.5million has come in during the past six months alone, mainly from existing shareholders.
NovaBiotics has already sounded out suitable partners for manufacturing and marketing its Novexatin treatment, while a number of other non-core healthcare products are at the development stage.
18th March 2009
Biologics burgeoning sector
Professor Andy Porter has made a succession of life-changing moves to become one of the key players in Grampian’s fast-expanding life-science sector. Professor Porter, along with Dr Keith Charlton and Dr Gillian Strachan, have set up Grampian Bio Partners, an investment company focused on early stage life-science businesses mainly in Scotland. Of NovaBiotics he says "Perhaps one of the most exciting prospects we have helped is Novabiotics, which was spun out from the Rowett Institute of Nutrition and Health in Aberdeen, and in February this year won the BioIndustry Association’s Rising Star Award. The company is about to take its first drug – for a medical condition that has a market worth more than £3.5billion annually – into clinical trials."
11th February 2009
SCRIP World Pharmaceutical News
NovaBiotics wins BIA "Rising Star" award
The Aberdeen, Scotland-based drug design company NovaBiotics, which is developing a new class of peptide anti-infectives, has won the UK BioIndustry Association's 2009 "Rising Star" award.
NovaBiotics' lead candidate is Novexatin® (NP213), a topical product that is expected to enter clinical trials for fungal nail infections later this year.
6th February 2009
Novabiotics Ltd wins Rising Star Award at the BioIndustry Association Thistle Bioscience Forum
Novabiotics Ltd won the Rising Star Award for 2009 at the BioIndustry Association (BIA) Thistle Bioscience Forum yesterday. The Rising Star Award recognises companies that through their presentation, demonstrate to the panel a clear vision of ambitions for development together with an analysis of their business model and technologies.
NovaBiotics, based in Aberdeen, is a drug design company which plans to commercialise a new class of antimicrobial peptide therapies.
Dr Barbara Blaney, Director, BIA Scotland, said:
“With a strong presentation on their core technology platform, strategy for market and competitor awareness, as a ‘clinic-ready’ company, Novabiotics was chosen unanimously by the panel as winner.”
The BIA Thistle Bioscience Forum attracted the life sciences community from the UK and beyond to discuss the secrets for success through collaborations, deals and new ventures. With business development so key to company growth in the current economic climate, the Forum focused on funding opportunities, collaborations, licensing, working with big pharma and the research councils.
Dr Barbara Blaney, Director, BIA Scotland, said:
“The life sciences sector has been, and can continue to be, an economic success story for Scotland. It is so encouraging to see the wealth of talent driving the industry forward.”
February 2009
Senior Management Opportunities in Scotland
Non-executive Director John Pool, talks to Talent Scotland about his work in the Life Science industry in Scotland and how strong management is the key to surviving the current economic situation.
Of NovaBiotics he says "“We got the best management we could in place and developed a strategy to fast-track the technology to market and revenue,” he added. “Four years later we are expecting to have a deal in place this summer after our phase 2 trials.”
Read more...
January 2009
Young Company Finance, Issue 121
NovaBiotics prepares for clinical trials
NovaBiotics, based in Aberdeen, is a drug design company which plans to commercialise a new class of antimicrobial peptide therapies.
Its lead product Novexatin®, a topical (brush-on) treatment for nail fungus, completed pre-clinical development in October, and will enter clinical trials within the next few weeks, with completion expected in September (subject to regulatory approvals).
According to founder and chief executive Dr Deborah O'Neil, the company took pains last year to trim down and re-focus.
At the end of the third quarter of 2008 NovaBiotics raised £750k from existing investors (Barwell plc and the SCF, plus individual investors), and it is in the process of raising around $1.5 million possibly in two stages, with the first expected to complete in mid February.
Provided that Novexatin clears its clinical trials successfully, it can go straight to market in September, and NovaBiotics is in contact with potential partners for this purpose. The company is also now turning to some of its non-core product prospects for commercialisation. These are anti-infectives for consumer healthcare products, and will not be subject to the same clinical trials regime as Novexatin
read more...
September 2008
Beating the bug
CEO Dr Deborah O’Neil explains to g2i the NovaBiotics business model of a step-wise market penetration approach resulting in a streamlined development process. To date, NovaBiotics has raised £6.5m, unusually without going to a venture capitalist.
She goes on to describe why NovaBiotics technology and application are very novel, with all the evidence to suggest their product will work in four weeks. Other planned products include a systemic anti-fungal drug for life-threatening Candida infections and after that, drugs focused on hospital and community-acquired bacterial infections (including MRSA), respiratory infections associated with cystic fibrosis, and other infections such as acne, burns and ulcers.
Read more...
July 2008
Life Sciences
NovaBiotics CEO Dr Deborah O’Neil details why Aberdeen City and Shire have a bright future in the life science sector. She explains “the support on offer from the Aberdeen based enterprise agencies, our fellow local life science companies and the Aberdeen city and Shire life science network and forum, both financial and practical, has been key in creating an environment in which biotechnology can prosper and ensuring that the Aberdeen based companies live up to and deliver on their phenomenal promise”.
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March 2008
Around 100 school pupils from Aberdeen City and Shire descended on the University of Aberdeen for a Bioscience Careers event. The S4 to S6 pupils, biology teachers and guidance staff heard from the Dr Deborah O’Neil, CEO of NovaBiotics, Professor Andy Porter, Professor of biotechnology and Dr Caroline Barelle, head of shark antibody development, Wyeth Research Scotland who have established successful careers first in academia and later in industry. They all have first hand experience of founding and working for world beating Scottish biotechnology companies and large bio-pharmaceutical corporations. Pupils are attended from Kemnay, Meldrum and Peterhead Academies, Robert Gordon's College and St Margaret's School for Girls.
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December 2007
The Joint UK Biotechnology Company Showcase/Genesis VII
The 7th annual Genesis conference took place in the Queen Elizabeth II Conference Centre in historic Westminster. As the "UK's largest biotechnology networking conference", the organizers of the event hoped that it would match the success of the previous year. As part of the session focusing on infectious diseases, Novabiotics presented its pipeline of novel antifungals and antibiotics, including NP-213, a treatment for the orphan indication of onychomycosis.
Read more...
2007
Talent Scotland talks to Dr Charrier about his academic journey that brought him from France to the cutting-edge world of commercial microbiology.
Dr Charrier studied for a degree in biological sciences at the University of Montpellier, where he carried out an end-of-study work placement at the University of Paisley. Having enjoyed his experience at the University of Paisley, Dr Charrier decided to continue his studies in Scotland. He was able to get into the third year of a microbiology degree course at the University of Edinburgh and after two years qualified with a BSc Honours. By this time he had a strong desire to continue his studies in scientific research and a PhD seemed to be the obvious choice. He was offered a PhD position at the Rowett Research Institute in Aberdeen to look at the biochemistry and microbial ecology of butyrate formation in human colonic bacteria, so moved up to the city where he has been living ever since.
Dr Charrier had a real interest in carrying on studying the relationships between microbes and the human hosts and knew of someone who worked at NovaBiotics and got in touch towards the end of his thesis. After a couple of meetings with NovaBiotics, he was offered a job and started in January 2006.
He says of working at NovaBiotics “so far this work has been an absolute dream since the company is very keen for me to have a lot of intellectual input into the work. Project management is achieved through regular meetings with the Head of Research to ensure we meet deadlines. On the top of that I’ve been encouraged and received full support to present data at international conferences and to set the scene for further projects”.
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Registered in Scotland No. SC272344. Registered Address: NovaBiotics Ltd, Cruickshank Building, Craibstone, Aberdeen, AB21 9TR, UK
© NovaBiotics Ltd 2009.
All Rights Reserved
Last updated
25 January, 2010
