BioWorld International Correspondent

PARIS - Novexel, a specialty pharmaceutical company, initiated a multidose Phase I trial of NXL 103, an orally administered antibiotic for the treatment of bacterial respiratory infections.

The company's CEO, Iain Buchanan, pointed out to BioWorld International that the trial is equivalent to a Phase Ib, since a single-dose Phase I trial already has been carried out.

Novexel, which is based at the biocitech science and business park in the Paris suburb of Romainville, was established in December as a spin-off from Aventis Pharma, a subsidiary of Paris-based Sanofi-Aventis Group.

Sanofi-Aventis has a 25 percent shareholding in the company, in addition to which Novexel raised \40 million in an initial financing from five European venture capital firms. The funding round was led by Atlas Venture, of Paris, and the other participants were Sofinnova, of Paris; the Paris office of 3i; Abingworth, of London; and Novo A/S, of Copenhagen.

Novexel also inherited a portfolio of anti-infective and antibacterial drug programs and intellectual property from Sanofi-Aventis, including several compounds in clinical or late-stage preclinical development.

The launch of the second Phase I trial of NXL 103 triggered a milestone payment from Sanofi-Aventis, which amounted to "millions of euros," Buchanan said. Sanofi-Aventis retains an option to take over the development of NXL 103 under the contract concluded between the companies.

NXL 103 is a streptogramin-type antibiotic that inhibits proteosynthesis at the level of bacteria. In preclinical studies, it demonstrated powerful activity against all the major pathogens affecting respiratory paths, including strains that are resistant to penicillin, macrolides and quinolone. Novexel's other assets include a second compound in clinical development - NXL 201, an antifungal for the treatment of severe fungal infections. The compound was out-licensed to Indevus Inc., of Boston, by Sanofi-Aventis to speed up its development, and Indevus started a Phase I trial of the product in late 2004.

In addition, Novexel has three other antibacterials at the preclinical stage: NXL 102, a topical antibacterial that was due to enter the clinic in 2005, although Buchanan said he was not sure that a Phase I trial would actually get under way before the year end; NXL 104, a beta-lactamase inhibitor against hospital-acquired infections; and NXL 101, a new chemical class topoisomerase IV inhibitor against Gram-positive bacteria, including MRSA.

Buchanan said the topical antibacterial probably would be the first product that Novexel brings to market, which would not be before 2008. He added that the company likely would require additional funding at some stage, but not before 2007 and then only if its clinical development program fulfills its hopes and expectations.