The News

Novexel initiates phase II clinical trial of NXL103 for treatment of community acquired pneumonia (CAP)

13/11/2007

-- 300 patients to be enrolled in double blind, multicenter, multinational, randomized comparative trial of NXL103 in the treatment of Community Acquired Pneumonia (CAP) --

Paris, France, 13 November 2007 – Novexel, the pharmaceutical company focused on the discovery and development of novel antibiotics and anti-fungals, announced today that its oral steptogramin-class antibiotic, NXL103 (PI + PII), has advanced into Phase II clinical testing.

The double blind, randomized, multi-center, multi-national (Bulgaria, Chile, Croatia, Estonia, Germany, Peru, Poland, Romania, South Africa, Ukraine) trial will investigate the efficacy, safety and tolerance of two doses of NXL103 vs. comparator in a three arm study with 100 patients in each arm, for the treatment of community-acquired pneumonia (CAP) in adults.

Sanofi-aventis holds an option on NXL103 until the end of Phase IIa. Under this agreement, initiation of this clinical trial triggers the payment of a quarterly option fee from sanofi-aventis to Novexel.

Attributes of NXL103 include bactericidal activity against multi-resistant S. pneumoniae, H. influenzae, and S. aureus, including MRSA, and a lack of cross-resistance with other antibiotics. It is further anticipated that NXL103 will have a low propensity to select for or induce resistance. 

CAP is one of the most common infectious diseases treated in the ambulatory and hospital setting. Prospective population studies from the UK, Finland, and North America have reported an annual incidence of CAP of between 5 and 11 per 1000 in the adult population [1]. Most cases are mild but mortality among hospitalised patients is high varying from 4-15% [1]. The direct healthcare cost of CAP in the USA has been estimated at $8.4 billion, 92% of the costs being for the inpatient care of 1.1 million patients and the remaining costs for the 4.4 million outpatient consultations [2].

Contacts:

Novexel
Iain Buchanan
CEO
Tel: +33 1 5714 0777

Financial Dynamics
Julia Phillips
Tel: +44 (0)207 831 3113
 

About Novexel:

Novexel is a pharmaceutical company that researches and develops novel class antiinfectives for the treatment of severe and difficult to treat bacterial and fungal infections. Novexel’s focus is on novel antimicrobial compounds with activity against multi-resistant organisms.   Four compounds are in development:  the oral streptogramin anti-bacterial compound, NXL103, in Phase II; NXL101, a bacterial topoisomerase inhibitor targeting Gram-positive bacteria, in Phase I;  NXL 104, a wide spectrum ß-lactamase inhibitor, in Phase I, and the aminocandin anti-fungal, NXL201, currently undergoing reformulation studies after initiation of Phase I trials.  Novexel’s preclinical research pipeline includes non-β-lactam inhibitors of Penicillin Binding Proteins that the company plans to develop for the treatment of nosocomial infections.  Novexel holds exclusive worldwide development and commercialization rights on all compounds in its pipeline except for NXL103, on which sanofi-aventis holds an option until the end of Phase IIa.

References

1. BTS Guidelines for the Management of Community Acquired Pneumonia in Adults. Thorax, 2001. 56 Suppl 4: p. IV1-64.
2. Niederman, M.S., et al., The cost of treating community-acquired pneumonia. Clin Ther, 1998. 20(4): p. 820-37.