Lynovex™ Orphan Drug Status
NovaBiotics is delighted to announce that it has received a positive COMP opinion on the application for orphan designation of its novel dual mucolytic-antibacterial Lynovex™, for the treatment of cystic fibrosis.
NovaBiotics shall be attending BIO 2011 (27th - 30th June 2011)
NovaBiotics are delighted to announce they shall be attending, and have been selected to present, at the BIO International Convention 2011 being held in Washington DC from the 27th June 2011 until the 30th June 2011.
NovaBiotics shall be attending BioDundee 2011
NovaBiotics shall be attending BioDundee 2011 on the 8th & 9th June 2011. For full details of the meeting click the link below.
NovaBiotics features in IMS Drug News
NovaBiotics can announce that they are featured in IMS Drug News. To read the article click on the link below.
NovaBiotics shall be attending BioTrinity 2011 from 12th-14th April 2011
NovaBiotics shall be attending BioTrinity 2011. BioTrinity 2011 will be the largest gathering of the UK's bioindustry, and is Europe's fastest growing biopartnering and investment conference, facilitating more meetings with more investors than any other UK conference. BioTrinity 2011 will feature a showcase of the best of the UK's emerging and clinical stage companies. For further detail on BioTrinity 2011, follow the link below.
http://www.biotrinity.com/silverstripe/
NovaBiotics are attending the UK-Netherlands Joint Symposium on Antimicrobial Peptides, Durham UK.
NovaBiotics are looking forward to attending this two day antimicrobial peptide symposium. This symposium brings together researchers from both the UK and the Netherlands working in different areas of antimicrobial peptide research.
Patents granted in key territories as Novexatin® moves closer to further clinical development and commercialisation
NovaBiotics, a leading clinical-stage biotechnology company, today announces that it has further secured the global intellectual property (‘IP’) position of its lead product, Novexatin® through recent patent grants in the US, EU and other territories worldwide. Novexatin® is a topical treatment for fungal nail infection and NovaBiotics’ recent patent grants protect the use of its core peptide technology in this and other related target indications.
The Company’s granted and pending IP not only protects the use of the core structure of Novexatin®, but of a related family of anti-infective peptides derived from the same technology platform. This is a critical milestone for the Company with key grants for its lead and follow-on products being secured a relatively early stage in their lifecycle.
NovaBiotics’ current antifungal product portfolio includes Novexatin® a phase 2b-ready clinical asset and Novamycin®, a candidate treatment for potentially life-threatening blood-stream and deep tissue yeast and mould infections (predominantly Candida). In addition, NovaBiotics’ antibacterial peptide drug candidate, Novarifyn™ and novel mucolytic agent NM001 are now at the early proof of efficacy stage for the treatment of respiratory infections including multi-drug resistant forms and those associated with cystic fibrosis.
Dr Deborah O’Neil, Founder, commented: “Recent patent grants in key territories for our expanding product portfolio is an important step in NovaBiotics’ development, particularly as we bring our lead product Novexatin® closer to market. This undoubtedly adds significant further value for the interested parties with whom we are in ongoing discussions for Novexatin®.”
NovaBiotics’ IP portfolio covers eight patent families which consist of more than 50 patents pending and granted worldwide.
Peptide Formulation & Product Development Forum
NovaBiotics will take part in a prestigious Marcus Evans forum in Vienna focused on some of the key challenges in peptide drug development around formulation and product development. Dr. O’Neil is an invited speaker and joins industry leaders in sharing NovaBiotics’ experiences in taking their Novexatin® peptide from concept to clinic and in parallel, developing Novamycin® as a related antifungal peptide intended for very different clinical use than the company’s lead product.
NovaBiotics selected to present at Bio-Europe 2010
NovaBiotics is looking forward to taking ongoing commercial discussions around Novexatin® and its pipeline products further forward with meetings scheduled at this year’s BioEurope event. The Company has also been selected to present an update on recent progress and its commercial aims alongside other leading biotechnology businesses in the parallel speaker sessions that will run throughout the 3 day event. NovaBiotics is delighted to attend the event in Munich as part of the Scottish trade mission led by Scottish Development International.
4th October 2010
Datamonitor
Life Sciences Scotland
BioPortfolio
London Stock Exchange
The Scotsman
The Telegraph
Isogenica, a biotechnology company, has entered into a collaboration agreement with NovaBiotics, a clinical-stage biotechnology company, to fast-track the development of NovaBiotic's platform peptide anti-infective technology.As part of the agreement, NovaBiotics will work with Isogenica on two research projects, one concerning peptide selection and the other concerning peptide maturation with the aim of expanding Novabiotic's product portfolio.
Deborah O'Neil, founder of NovaBiotics, said: "I am delighted to be working with Isogenica on this research project. They are experts in the field of peptide engineering and their CIS-Display technology is ideal for screening NovaBiotic's vast library of anti-infective peptides as efficiently as possible and enabling NovaBiotics to fast-track the development of its product pipeline."
Financing targets achieved
NovaBiotics is pleased to announce that it has successfully concluded the second part of this year’s planned funding rounds to bring the total of cash raised in 2010 to beyond the £2.5 m target set for the year. This additional working capital will allow continued progression of the Company’s lead and pipeline programmes. The board and management gratefully acknowledge the continued support of shareholder base who have provided the cornerstone for the Company’s £3m financing in the current year.
NovaBiotics selected to present at ICAAC 2010
NovaBiotics shall be attending ICAAC 2010 in Boston, MA, from 12th - 15th September where they are delighted to announce they have been selected to present.
8th July 2010
The Excellent Results From the Unblinding of the Novexatin® Phase IIa Clinical Trial have led to Further Press Coverage of NovaBiotics' Lead Product Candidate for the Treatment of Fungal Nail Infection.
30th June 2010
Biospace
London Stock Exchange
Unblinded Phase IIa Clinical Trial Data Delivers Excellent Results for Novexatin®, NovaBiotics' Lead Product Candidate for the Treatment of Fungal Nail Infection.
NovaBiotics, the clinical-stage biotechnology company, today announces the initial unblinded results from its Phase IIa clinical study for Novexatin®. All study end-points were met in the trial which had been designed to assess the safety and tolerability of the novel antifungal drug candidate.
Novexatin® was confirmed as being safe and well tolerated in all study subjects by the leading global clinical research organisation who conducted the study. These are very positive results in the context of the well described and significant safety/toxicological shortcomings of some currently available treatments.
48 patients with fungal nail infection were dosed daily with Novexatin® for just 28 days, on a single toe nail. Although not an efficacy study, analysis of the clinical improvement of the treated nails, as a measure of Novexatin®’s pharmacodynamic properties (i.e. its ability to penetrate the nail), revealed much better than expected initial evidence of efficacy during both the short 28-day treatment period and the 6-month follow-up assessment window. In this respect Novexatin® has thus far outperformed any other drug candidate developed to treat fungal nail infection and the Company now looks forward to confirming these exciting indicative findings in larger clinical studies specifically designed to assess efficacy in patients. NovaBiotics is currently in the process of filing an investigational new drug (“IND”) application for approvals to undertake these trials in the United States.
The results of the clinical trial strongly suggest that Novexatin® has the potential to revolutionise the market for the treatment of fungal nail infections which affects in excess of 12% of the world’s population. The safety data and pharmacodynamic assessment outcomes achieved for Novexatin® are more compelling than data derived from other products (marketed and in development) tested in larger studies, during which each drug was administered for between three and ten times longer than the Novexatin® 28-day study.
Novexatin® is part of a broad portfolio of products which are being developed by the Company using its unique patented peptide anti-infective technology. The next product in the pipeline is Novamycin®, a candidate treatment for potentially life-threatening blood-stream and deep tissue yeast and mould infections (predominantly Candida) which is expected to enter clinical development in 2011.
Dr Deborah O’Neil, Founder, commented: “Now the study has completed in patients and we can interpret the significant data set acquired over the past 6 months, the positive results take the next key steps to confirming what we have always known from the laboratory; Novexatin®’s ability to safely remedy a very common and hard to treat condition. This safe and novel treatment is designed to be closely related to the body’s natural antifungals and addresses the various and well described shortfalls of the limited number of existing therapies that currently serve a global fungal nail infection market potentially worth $5 bn.”
“The data collected now points a very clear path to a phase IIb study which will take us closer to bringing this product to market.”
Successful Completion of Phase IIa clinical trial for Novexatin®, IND filing planned for Phase IIb study and successful £1.6m rights issue
NovaBiotics is delighted to confirm that following the successful completion of its Phase IIa clinical trial for its lead product Novexatin®, a brush on treatment for fungal nail infection, it is now preparing for further clinical evaluation and plans to file an investigational new drug application (IND) with the US Food and Drug Administration (FDA) for a US-based Phase IIb study.
The Company also announces today that it has secured an indicative £1.6m from existing shareholders and is on track to reach its H1 financing target of £2.5 m to fund further development of Novexatin® and its product pipeline.
18th May 2010
Successful Completion of Phase IIa clinical trial for Novexatin®, IND filing planned for Phase IIb study and successful £1.6m rights issue
Biotechnology company NovaBiotics, confirms that following the successful completion of its Phase IIa clinical trial for its lead product Novexatin®, a brush on treatment for fungal nail infection, it is now preparing for further clinical evaluation and plans to file an investigational new drug application (IND) with the US Food and Drug Administration (FDA) for a US-based Phase IIb study.
This announcement follows analysis of the final microbiological data set from NovaBiotics' 48 patient Phase IIa clinical study in which subjects were dosed daily with Novexatin® for 28 days. The study met its end-points of demonstrating safety and tolerability of the test item and pharmacodynamic analysis indicates that the majority of patients remain infection free 6 months after a 28 day treatment course.
The Company also announces today that it has secured an indicative £1.6m from existing shareholders and is on track to reach its H1 financing target of £2.5 m to fund further development of Novexatin® and its product pipeline.
Dr Deborah O'Neil, Founder, commented: "The phase IIa data we have generated for Novexatin® provides a clear route forward for further development and an IND filing to facilitate a phase IIb study will be a major milestone for what we believe is world beating technology. Completion of the fundraising is key to enabling us to do that and I would like to take this opportunity to thank our supportive shareholders. I am also delighted that NovaBiotics has been selected to present at this year's BIO and we already have an extensive schedule of partnering meetings and a full programme."
The fungal nail infection market is estimated to be worth $5bn globally. Novexatin® is part of a wider portfolio of products which are being developed from NovaBiotics' platform technology. The Company's second drug candidate is Novamycin®, a fast-acting antifungal peptide to treat potentially life-threatening systemic yeast and mould infections. At BIO, Dr. O'Neil will be discussing exciting new developments on Novamycin's safety and efficacy in vivo. NovaBiotics' pipeline also comprises antimicrobial peptides and compounds for respiratory, system and dermal infections.
March 2010
NovaBiotics selected to present at BIO 2010
NovaBiotics is delighted to have been selected as one of this year's presenting companies at BIO (Chicago IL, May 3rd - 6th). Combined with a busy partnering schedule and full agenda with the Scottish delegation, Dr. Deborah O'Neil and Professor Andy Porter are looking forward to the event and to updating the industry on recent NovaBiotics developments and plans for the future.
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
11th January 2010
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.
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