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Bolstered by an EU orphan drug designation for its drug candidate for cystic fibrosis, Lynovex (cysteamine), UK-based NovaBiotics revealed to Scrip that it plans to begin a first-in-man, safety/tolerability and evidence of efficacy study of the product in 2012, followed by other trials in 2013.

The company announced that the Committee on Orphan Medicinal Products (CHMP) of the European Medicines Agency (EMA) has granted orphan status to the novel dual mucolytic-antibacterial drug for the treatment of cystic fibrosis and added that it is "currently in discussions with a number of interested parties with a view to licensing or co-developing the drug".

NovaBiotics stated it would "now progress with follow-on orphan applications for paediatric use and also applications for orphan drug designation in the US".

"This novel drug candidate is expected to be tested in patients in 2012," the biotech firm highlighted. It told Scrip that the study slated for next year would test Lynovex when used in conjunction with conventional inhaled ABX (antibiotic) therapies in the first instance. In 2013, NovaBiotics said it would initiate a second and third trial to further assess efficacy.

The company confirmed that it intends to partner the product, and "as per our core business model [this is] most likely after the second clinical study". With respect to its finances, it said: "NovaBiotics remains fully equity funded (still pre-revenue) and this is how development has been/will be funded in the short-term for Lynovex, but as the programme develops towards final clinical studies, revenue from Novexatin and Luminaderm commercialisation deals will be reinvested into the Lynovex programme."

Last year, NovaBiotics released positive un-blinded Phase IIa data for its lead product candidate Novexatin (NP-213), a treatment for fungal nail infection and at the time said it was in ongoing partnering discussions for the medication ( scripintelligence.com, 5 July 2010).

In an update the company said that partnering discussions were still active or ongoing according to region (with talks going on in the US, Japan and South America among others). It noted that NovaBiotics is also open to global deals for Novexatin.