Basilea Pharma's Antibiotic Shows Non-inferiority in Late-Stage Trial

clinical trial research

Basilea Pharmaceutica, based in Basel, Switzerland, announced positive topline data from its Phase III TARGET study of deftobiprole for acute bacterial skin and skin structure infections (ABSSSI).

ABSSSI are some of the most common infections found in hospital settings and include antibiotic-resistant strains. They are growing to be more common and are a challenging medical problem.

Ceftobiprole medocaril is a cephalosporin antibiotic for intravenous dosing. It has rapid bactericidal activity against a broad range of Gram-positive and Gram-negative bacteria, including methicillin-susceptible and resistant Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas species. It is currently approved and on sale in major European countries, Argentina, Canada, Jordan, Peru and Saudi Arabia for adults with community-acquired pneumonia (CAP) or hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).

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The antibiotic is presently in Phase III development for a possible regulatory application in the U.S.

“The successful completion and positive results of our Phase III study in skin infections marks the achievement of a significant milestone towards a filing of ceftobiprole in the U.S.,” stated Marc Engelhardt, Basilea’s chief medical officer. “The second study, in Staphylococcus aureus bloodstream infections, is well on track and is expected to deliver topline results in the second half of 2021. In both indications, ceftobiprole addresses unmet medical needs through its broad-spectrum rapid bactericidal activity, with the ability to cover both Gram-positive and Gram-negative pathogens and with the well-established safety profile of a cephalosporin.”

The TARGET clinical trial looked at 679 patients. The antibiotic hit the primary efficacy objective of non-inferiority to vancomycin plus aztreonam in the intent-to-treat (ITT) population. The primary endpoint of early clinical response was evaluated on a 20% or more decrease from baseline in lesion size at 48 to 72 hours after the antibiotic was dosed.

Ceftobiprole was also non-inferior to vancomycin plus aztreonam for a secondary endpoint of investigator-assessed clinical success based on resolution of baseline symptoms of infection both in the ITT and the clinically evaluable (CE) patient populations at what is called the test-of-cure (TOC) visit, which took place 15 to 22 days after dosing.

Antibiotic development has become a difficult business. This has much to do with the economics of drug development, where it can take 10 to 15 years to develop and drug at a cost of $1 billion or more. Pharmaceutical companies than recoup their costs and move into profitability by charging a high enough price or sell enough of the drug to earn back those costs and reward investors.

As a business model for most drug, antidepressants, statins, oncology medications, even the newest, high-priced biologics, this works. But antibiotics don’t fit into the model. Unlike, for example, cancer drugs, most antibiotics are inexpensive. The ones with high price tags are typically reserved for rare hospital use. And unlike drugs for chronic diseases, such as diabetes or arthritis, people usually take antibiotics for only short periods of time.

As a result, big pharma has largely gotten out of the antibiotics business, with about 90% of research on new antibiotics conducted by small biotech companies with market caps of less than $100 million.

Basilea focuses on oncology, hospital antibiotics and hospital antifungals. It markets two anti-infectives, Cresemba and Zevtera, and has three cancer drug candidates in development. It was founded in 2000 as a spin-out from Roche. It currently has 225 employees.

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