Basilea announced this morning that ceftobiprole delivered a positive result from the Phase 3 registration study ERADICATE targeting patients with bacteraemia caused by Staph aureus (SAB).
This is a very welcome development, with Basilea looking to file a New Drug Application in the US before the year-end. ERADICATE was one of two Phase 3 studies conducted by Basilea under the auspices of an FDA Special Protocol Assessment (SPA) and largely paid for (70%) by BARDA. The other Phase 3 study, TARGET, has already generated positive data in severe skin infections (ABSSSI). A positive result in both trials was required for regulatory approval. In the release this morning, we also note that the company will explore the possibility of gaining an additional indication of community-acquired bacterial pneumonia (CABP) based on a previously conducted Phase 3 trial.
We note the highly encouraging top-line results disclosed today and look forward to more detailed TARGET presentations at a future medical conference. 390 SAB patients were enrolled, with ceftobiprole meeting the primary endpoint of overall success in the modified intent-to-treat (mITT) population at 70 days and compared to patients receiving the alternative anti-MRSA antibiotic daptomycin, with or without aztreonam (for Gram-negative coverage). The overall success rate was 69.8% with ceftobiprole, compared to 68.7% with daptomycin. The statistically adjusted difference between ceftobiprole and the comparator group was 2.0% (95% confidence interval: -7.1% to 11.1%). Reassuringly, initial subgroup analyses (all-cause mortality, new complications of SAB, and overall success in the clinically evaluable population) showed no significant differences between the two treatment groups. The safety profile of ceftobiprole was in line with existing experiences (higher gastrointestinal effects), with the overall rates of adverse events similar between the two groups. We note that ceftobiprole has been available commercially outside of the US (brand name Zevtera) for the treatment of Hospital-Acquired and Community-Acquired Pneumonia (HAP/CAP).
With positive Phase 3 data in both studies now secured, we look forward to productive partnering discussions, at which point we will reassess our sales forecasts. Given Basilea's recent refocusing on its anti-infectives franchise, TARGET and ERADICATE's positive outcomes suggest a welcome diversification of revenues, particularly in the important US market. SAB remains an unmet need with few treatment options, particularly in patients suffering from MRSA. ERADICATE's success in SAB, along with the previously reported positive Phase 3 TARGET study in patients with severe skin infections, should facilitate approval in the US - the key market for anti-MRSA antibiotics. We have previously highlighted the commercial potential of ceftobiprole, suggesting a peak sales expectation of approximately $400m. However, we suspect that much will depend on a commercial partner's existing franchise and resources.
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Basilea Pharmaceutica is a client of Calvine Partners, and as such, this publication is not independent and should be considered a marketing communication under FCA Rules. None of the information contained in this publication should be considered as any form of advice.