ContraFect’s CEO has dubbed results from a discontinued phase 3 trial “uninterpretable," and yet the biotech is still clinging to hope that its lead candidate has potential in several indications.
Six months ago, ContraFect revealed that exebacase had failed an interim futility analysis in a phase 3 clinical trial called DISRUPT. In a new top-line data summary shared after market close Monday, the company said the trial was unsuccessful due to an "unprecedented clinical response in the placebo arm."
CEO Roger Pomerantz, M.D., also blamed the timing of the study, which was conducted during the COVID-19 pandemic, and said the results were "uninterpretable."
Due to patient randomization, there was a difference in the baseline disease severity of patients in the exebacase arm versus those receiving placebo, with a higher percentage of patients receiving exebacase considered to have an extremely poor prognosis than in the placebo group, according to ContraFect.
With all that said, Contrafect seems determined to plow on. The New York-based biotech believes exebacase should still be pursued as a treatment for patients with S. aureus bacteremia, including MRSA strains, a spokesperson told Fierce Biotech via email.
“We are continually in discussions with other companies in regards to exebacase, but also with CF-370,” the spokesperson said, referencing the company’s preclinical lysin targeting gram-negative pathogens. “Both programs have demonstrated potential to offer patients superior outcomes and we will work closely with others also seeking the best possible treatments for patients.”
The trial’s full results and clinical study report are expected in the first quarter of 2023. These results, including safety data, will be used as part of any future regulatory submissions for exebacase’s potential approval, Pomerantz said. The CEO also believes another study among MRSA patients should be conducted, either by ContraFect or a partner, citing “the response rates and strong safety profile observed.”
While the biotech doesn’t currently have any other active clinical trials, it is ramping up to launch a phase 1b/2 prosthetic joint infection study of exebacase during the first quarter of 2023.
The company’s stock has changed little over the past few days, resting at 10 cents per share as of 10:30 a.m. ET on Dec. 20.