In its earnings presentation this week, Johnson & Johnson (J&J) announced that it had ended its clinical development program for cadazolid, its Phase III antibiotic for Clostridium difficile infections (CDIs). This news came after a period of uncertainty over the future of the drug following the June 2017 announcement that cadazolid had failed to meet the primary endpoint in one of its two Phase III trials. J&J plans to present further data from cadazolid’s Phase III development program at the 2018 European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).
J&J gained cadazolid as part of its acquisition of Actelion in June 2017. At the time, cadazolid was under investigation in two Phase III clinical trials assessing the clinical cure rate of CDI as a primary endpoint, and the rate of CDI recurrence as the secondary endpoint. In June 2017, Actelion announced that although cadazolid had met the primary endpoint of non-inferiority to vancomycin in the first Phase III trial, it had not met the same endpoint in the second Phase III trial. Given these results, it was initially unclear whether J&J intended to continue with the clinical development of cadazolid once the acquisition of Actelion had completed.
Although J&J’s recent announcement rules out any further development of cadazolid for the treatment of CDIs, there may be some potential for the drug a treatment for other antibiotic infections. However, the company has not indicated that it wishes to pursue this route. J&J must now rely on future sales of ponesimod, Actelion’s other lead molecule, to ensure that its 2017 $30B buyout was worthwhile.
The news of cadazolid’s discontinuation in the CDI space will be welcomed by Summit Therapeutics, whose Phase III antibiotic, ridinilazole, was set to be in direct competition with J&J’s drug. Summit currently has two Phase III trials planned for ridinilazole, after the drug was observed to have strong efficacy against CDIs in Phase II studies.
With cadazolid out of the picture, Summit’s major competition will be from Merck’s Dificid (fidaxomicin), a C. difficile-selective antibiotic that launched in the US in 2011. However, historical trends suggest that physicians are reluctant to move away from generic vancomycin and use more expensive, albeit more efficacious, treatments for CDIs. GlobalData therefore believes that drug developers such as Summit should aim to leverage cost-effectiveness studies to encourage the greatest uptake for any new CDI treatment.
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GlobalData (2018). Expert Insight: Rebiotix Acquisition Further Solidifies Ferring’s Position in the Microbiome Space, April 2018, GDHC1701EI
GlobalData (2017). OpportunityAnalyzer: Clostridium difficile Infections (CDIs) – Opportunity Analysis and Forecasts to 2026, July 2017, GDHC070POA
GlobalData (2017). Expert Insight: With $62M BARDA Contract Secured, the Future for Summit’s Ridinilazole Looks Bright, September 2017, GDHC1427EI
GlobalData (2017). Expert Insight: Demonstrating Cost-Effectiveness Could Be Key to Success for Antibiotics in C. difficile Market, July 2017, GDHC1328EI