Actelion's antibiotic meets one endpoint, flunks another
- The antibiotic cadazolid, one of Actelion's lead drugs, has met the primary endpoint in just one of the company's two Phase 3 IMPACT trials in Clostridium difficile-associated diarrhea (CDAD), failing to demonstrate non-inferiority to standard-of-care vancomycin.
- Details of the results have not been released; the company has stated that it will "work diligently to complete the analyses of the full study results." The data will be published in journals and presented at upcoming medical congresses.
- Beyond the mixed efficacy results, cadazolid's tolerability and safety was described in the topline statement as "acceptable" by the company.
Johnson & Johnson sealed a $30 billion deal for Actelion in January 2017, driven by the prospect of access to a portfolio of drugs for pulmonary arterial hypertension (PAH), but also taking on the quinoxolidinone antibiotic cadazolid and the multiple sclerosis candidate ponesimod once the acquisition is complete.
Actelion hasn’t disclosed anything about cadazolid's future, but a Phase 3 failure may well put it in question, and in turn cast doubts on the value of Johnson & Johnson's acquisition of the smaller company.
The IMPACT clinical trial program includes two identical Phase 3 studies comparing the efficacy and safety of cadazolid versus vancomycin in patients with CDAD. The primary endpoint was clinical cure rate (resolution of diarrhea with no further need of treatment) at end of treatment, maintained for at least two days. About a fifth of people who go into hospital become colonized with C difficile, and about a fifth of those will develop CDAD. Recurrence rate is as high as 20% to 40%, rising to 65% after two or more lapses. CDAD is behind around 14,000 deaths in the U.S. each year.
Another of Actelion's drugs in Johnson & Johnson's pipeline is ponesimod, in development to treat multiple sclerosis. The Phase 3 trial, OPTIMUM, is expected to read out in the second half of 2018. Meanwhile, Actelion's drug discovery and early clinical pipeline has been spun out into a separate company, Idorsia.
- Actelion Statement
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