Shares at Switzerland’s Basilea have soared after the firm posted yet more positive data from a Phase III trial for its antibiotic ceftobiprole which reveal that the drug is an effective treatment for complicated skin infections.
The study showed that ceftobiprole, the first broad-spectrum cephalosporin to show efficacy in a large clinical trial against methicillin-resistant Staphylococcus aureus (MRSA), met its primary endpoint of statistical non-inferiority versus combination therapy and demonstrated high cure rates in patients with complicated Gram-positive as well as Gram-negative skin infections, including diabetic patients with foot infections.
This second pivotal double-blind study, called STRAUSS II, saw 828 patients treated with either ceftobiprole or the combination of ceftazidime plus vancomycin. Almost one-third of patients had diabetic foot infections of which three-quarters were moderate to severe cases.
91% of clinically evaluable patients were cured with ceftobiprole compared to 90% of patients treated with a combination therapy of ceftazidime plus vancomycin. The clinical response in patients with diabetic foot infections was 86% for ceftobiprole and 82% for combination therapy, respectively, and 20% of evaluable patients had confirmed MRSA infections. The clinical cure rate for ceftobiprole in MRSA patients was 91% compared to 86% for the comparator regimen, while one-third had infections involving a Gram-negative pathogen. The microbiologic eradication rates in these patients were similar at 84% in both treatment groups.
Chief executive Anthony Man said that “these are very strong clinical data [which] show that ceftobiprole monotherapy is non-inferior to standard combination therapy.” The treatment, which is partnered with Johnson & Johnson’s Cilag arm, has been granted fast-track status from the US Food and Drug Administration and “with two positive Phase III trials in complicated skin infections, we plan the first regulatory filing” this year, he added.
The positive results were no great surprise, following as they do the compound’s success in a Phase III study last year, and analysts at Bank Vontobel said in a note that they expect ceftobiprole to reach the market in 2008. The broker added that the drug could have peak sales of 1.5 billion Swiss francs though this is dependent on ceftobiprole being approved in a second indication, hospital-acquired pneumoniae. Results from a trial looking at the latter condition are scheduled for the second half of 2007.
Investors certainly seem to think that Basilea is onto something good with ceftobiprole and the firm’s shares ended on a record high of 228 Swiss francs.