Updated: ContraFect to terminate PhIII MRSA antibiotic trial — stock capsizes

14 Jul 2022
endpts.com
One year after BARDA backed ContraFect’s MRSA treatment, the Yonkers, NY-based biotech said Wednesday it will stop its Phase III trial of the asset early due to futility. The data safety monitoring board reviewed clinical response data from 84 patients, looking at superiority over the control arm at two weeks, and recommended the trial be stopped, the company said in a press release . The Phase III trial was originally designed to test exebacase — a lysin treatment that would dissolve bacteria cell walls — in 350 patients with bacteremia from MRSA, including those with right-sided heart inflammation. “This disappointing news reflects the long history of difficulties in treating life-threatening infections like MRSA bacteremia in patients with heterogeneous co-morbidities, and who are in need of immediate life-saving treatments,” ContraFect president and CEO Roger Pomerantz said in a statement. SVB Securities analysts Roanna Ruiz and Nik Gasic noted the unique trial design: ContraFect had designed its trial for superiority as opposed to non-inferiority in a risky bet to make exebacase an earlier treatment option for MRSA, a difficult-to-treat bacteria infection that led to some 20,000 deaths in 2017, according to the CDC. Why make that ambitious bet? When new antibiotics are approved on non-inferiority, they’re deemed a last resort , resulting in low returns for the developer. In 2019, Achaogen went bankrupt despite winning approval for Zemdri, its antibiotic for complicated urinary tract infections. BARDA had previously backed ContraFect on exebacase with an initial $9.8 million alongside $77 million in future payments. In reaction to the trial stoppage, ContraFect’s stock $CFRX all but collapsed, falling over 80% to around $0.50 this morning. In an email to Endpoints News , ContraFect CFO Michael Messinger said the biotech has not planned any non-inferiority trials for any of its programs, writing that “clinical superiority is critically important for new antibacterial therapies.” He added that ContraFect will “continue to evaluate the medical opportunities for exebacase, whether it remains in bacteremia or in another indication like prosthetic joint infections.” The antibiotic biotech plans to do its own analysis of the exebacase Phase III data before detailing future plans, according to the press release. On the financial end, Messinger noted the biotech was funded through 2022 prior to stopping enrollment in the study and is evaluating how its runway could be extended depending on the results of said analysis. This story was updated to include comment from Michael Messinger.
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