Cerexa
Based: Alameda, CA Why It's Fierce: Fast might be a better adjective to describe Cerexa. Created and spun off by the management team of Peninsula Pharmaceuticals after it sold to Ortho-McNeil, Cerexa launched with $50 million in venture capital backing that was co-led by Frazier Healthcare Ventures and New Leaf Venture Partners. They in-licensed Takeda's PPI-0903, an antibiotic that indicates effectiveness against MRSI, for all areas outside of Japan. They've also outlined a campaign to develop more hospital-based therapeutics. Less than two months after its official launch, Cerexa launched a Phase II trial and in mid-March got FDA fast-track status. Cerexa is placing its hopes on its ability to emerge swiftly as a key player in the search for antibiotics. PPI-0903 is a cephalosporin antibiotic designed for treating complicated skin and skin structure infections caused by methicillin-resistant Staphylococcus aureus (MRSA). MRSA has emerged as a growing scourge, appearing in community settings in a growing number of cases. Cerexa can already rely on the clinical and preclinical data obtained from Takeda's trials, which indicate that the drug has the potential to emerge as a broad-spectrum antibiotic, with positive data as well for treating penicillin-resistant Streptococcus pneumoniae. "The clinical and preclinical results to date are very encouraging, indicating that PPI-0903 is well tolerated and has excellent broad-spectrum coverage, including potent in vitro activity against increasingly resistant gram-positive pathogens such as MRSA," says Cerexa CEO Dennis G. Podlesak. What to look for: Solid efficacy data. The Phase 2 study in complicated skin and skin structure infections will investigate the efficacy and safety of PPI-0903 versus standard therapy in approximately 100 patients recruited from over 20 investigational centers. The primary efficacy endpoint for this study is clinical outcome at the test-of-cure visit, which occurs between 8 and 14 days after end of therapy. |
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