NovaBiotics Ltd
Cruickshank Building
Craibstone
Aberdeen
AB21 9TR
UK
20th January 2010
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
4th January 2010
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
20th November 2009
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.”
20th November 2009
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.
4th November 2009
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
3rd November 2009
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
1st November 2009
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
1st October 2009
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.
1st September 2009
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”.
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 and London Stock Exchange
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.