Basilea is halfway towards filing for approval of its broad-spectrum antibiotic ceftobiprole for serious skin infections in the US, after clearing the first of two phase 3 trials.
Ceftobiprole hit all primary and secondary efficacy endpoints in the TARGET trial involving 679 patients with acute bacterial skin and skin structure infections (ABSSSI), including non-inferiority to standard-of-care vancomycin plus aztreonam.
The main endpoint in the trial was early clinical response, defined as a 20% or more reduction from baseline in lesion size within 48 to 72 hours of antibiotic dosing.
The Swiss biotech is now waiting for the results of a second phase 3 trial – called ERADICATE – which is being conducted in bloodstream infections caused by superbug methicillin-resistant Staphylococcus aureus(MRSA).
Results from that trial are due in 2021 and if positive will clear the way for an FDA filing. Basilea had expected to file the drug with the FDA a couple of years ago, but that aspiration was knocked back by an FDA request for additional phase 3 data.
“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,” said Marc Engelhardt, Basilea’s chief medical officer.
Ceftobiprole is already marketed as Zevtera and Mabelio for hospital and community-acquired pneumonia (HAP and CAP) in Europe and other ex-US markets through multiple partner companies.
Analysts at Goetz Partners say however that the US is “the key market for MRSA antibiotics and accounts for 56% of our peak sales estimate for the drug… due mainly to the high incidence of MRSA in US hospitals and the higher propensity in the US to use novel products”.
Goetz is expectingBasilea to launch Ceftobiprole in the USin 2022, with peak sales of the drug reaching $225m in that market seven yearslater. As the drug is designated as a Qualified Infectious Disease Product (QIDP) by the FDA, it is in line for up to ten years of market exclusivity from launch.
Meanwhile, Edison analysts also think the big commercial opportunity for ceftobiprole is in the US, but they note that results from the TARGET trial could also be used to expand the label for the drug outside the US.
They have high expectations for the product given the challenge in making a good commercial return from novel antibiotics, modelling peak sales of $550m for the drug in 2027, with $317m of that total coming from the US market.