Basilea Pharmaceutica Ltd. announced positive topline results for the phase 3 ERADICATE study, evaluating ceftobiprole in the treatment of adult patients with bacterial bloodstream infections caused by Staphylococcus aureus (SAB). Basilea is planning to submit a New Drug Application (NDA) for ceftobiprole to the U.S. Food and Drug Administration (FDA) around year end 2022. In accordance with the agreed Special Protocol Assessment (SPA), Basilea will seek approval for SAB and acute bacterial skin and skin structure infection (ABSSSI) indications based on the successfully completed ERADICATE study and the TARGET phase 3 study, which was successfully completed in patients with ABSSSI in 2019.

In addition, the company will explore the possibility for gaining approval for a third indication based on a previously performed phase 3 study in community-acquired bacterial pneumonia (CABP). The ERADICATE study enrolled 390 patients with complicated SAB, including right-sided endocarditis. Ceftobiprole met the pre-specified efficacy objective of overall success in the modified intent-to-treat (mITT) population at 70 days after randomization, assessed by an independent Data Review Committee, within the pre-specified non-inferiority margin of 15% compared to daptomycin, with or without aztreonam.

The overall success rate was 69.8% with ceftobiprole compared to 68.7% with daptomycin, with or without aztreonam. The statistically adjusted difference between ceftobiprole and the comparator group was 2.0% (95% confidence interval: -7.1% to 11.1%). Initial subgroup analyses showed no significant differences between the two treatment groups.

Ceftobiprole was well tolerated and the observed safety profile was consistent with previous phase 3 studies and the post-marketing experience with ceftobiprole. In the ERADICATE study the overall rate of adverse events was similar between the two treatment groups. As expected, gastrointestinal side effects were more frequent with ceftobiprole.

Ceftobiprole was designated a Qualified Infectious Disease Product (QIDP) by the FDA for SAB, ABSSSI and CABP. Therefore, if approved, ceftobiprole would be eligible to receive ten years of market exclusivity in the U.S. from the date of approval. The U.S. represents the most important commercial market for ceftobiprole, with Basilea's estimate ranging from 80% to 90% of the global potential.

Basilea's ceftobiprole phase 3 program is funded in part (up to USD 134.2 million, which is approximately 70% of the total potential program costs) with federal funds from the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201600002C.