Novobiotics - Positive Initial Phase IIa Data
LONDON, Nov. 2, 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® 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.”
Ends
For further information please contact:
For further information please call:
NovaBiotics Ltd
Dr Deborah O’Neil 01224 711377
Buchanan Communications
Diane Stewart / Tim Anderson
0131 226 6150 / 0207 466 5000
Notes to Editors
NovaBiotics is a clinical-stage biotechnology company which was
founded in 2004 and focuses on the design and development of
antifungal and antibacterial therapeutics. NovaBiotics offers an
attractive mix of a clinical product, unique platform technology
and a robust product pipeline which the directors believe have the
ability to treat a range of poorly served and economically
significant infections including.
• Fungal nail infection
• Life-threatening blood stream and deep tissue yeast and
mould infections (e.g Candida)
• Respiratory Psuedomonal infections and those associated with
Cystic Fibrosis
• Antibiotic resistant and susceptible dermal, blood stream
and tissue Staphylococcal infections
• Acne and polymicrobial dermal infections
The company has a strong lead product in its first application for
the topical treatment of nail fungus
(“NP213/NovexatinTM”).
Competitive Landscape
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.
The efficacy and safety shortcomings of current therapies are such
that patient usage is restricted. In general, they involve lengthy
application regimes, are costly and associated with a high degree
of relapse. Available systemic treatments are also associated with
potentially very serious side effects and toxicity.
Novexatin® has an established preclinical safety and
toxicological profile and can be delivered to the nail in such a
way as to improve appearance and hydration of the nail.
Novexatin® penetrates full-thickness nail, remaining active in
the nail bed, without being absorbed into the skin. All of these
factors are unique to Novexatin® which has also been designed
with cost-effective manufacture and flexibility of formulation in
mind.
Posted: November 2009
