BioWorld International Correspondent
Basilea Pharmaceutica Ltd., the F. Hoffmann-La Roche Ltd. spin-out, gained FDA fast-track designation for its cephalosporin antibiotic, BAL5788, which is entering Phase II trials.
The compound, which is in development for treatment of complicated skin and skin structure infections (cSSSI), is active against a range of drug-resistant bacterial pathogens, including methicillin-resistant Staphylococcus aureus, methicillin-resistant Staphylococcus epidermidis and penicillin-resistant Streptococcus pneumonia, as well as other Gram-positive and Gram-negative pathogens.
"There's no other cephalosporin on the market that has these properties," Basilea Pharmaceutica Chief Development Officer Anthony Man told BioWorld International.
BAL5788 features a beta-lactam ring and acts by binding to penicillin-binding proteins (PBPs) that are involved in bacterial cell wall synthesis. The compound, which is administered as a prodrug via intravenous injection, contains two structural modifications that enable it to bypass common resistance mechanisms. One renders it immune to breakdown from beta lactamase enzymes. A separate modification lends it a high affinity for mutant PBPs to which existing cephalosporins cannot bind.
A broad range of Gram-positive and Gram-negative pathogens can give rise to cSSSI.
"The common feature is they require some form of surgical intervention," Man said. The Phase II trial will involve 40 to 50 patients in the U.S. and Europe who will be subject to advance screening to ensure that there are fully evaluable, both clinically and bacteriologically. "It's a very high-quality, difficult trial to do," Man said. Basilea aims to complete the study by the fourth quarter.
Basel, Switzerland-based Basilea, which received CHF206 million (US$154.9 million) at its founding in 2000, is 49 percent owned by its parent firm. Roche, also of Basel, has options on the first seven Basilea compounds, four of which are in clinical development. "It's very similar to the Genentech structure," said Chief Financial Officer Ronald Scott.
Basilea's lead compound, BAL4079, a treatment for hand dermatitis, completed a Phase II trial, and planning for a Phase III study is underway.
"We're still in discussions with Roche about that," Scott said.
BAL2299, an oral vitamin D congener in development for treatment of mild to moderate psoriasis, is in a Phase II trial, while BAL8557, a broad-spectrum antifungal, is undergoing a Phase I study.
Basilea has out-licensing options. It gained Roche's entire antibacterial and antifungal portfolio of development compounds and associated intellectual property, as well as a portion of its dermatology research and development compound and intellectual property portfolio, when Basilea was established.