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Business Update
DSMB Recommends DISRUPT Trial be Stopped for Futility
On July 13, 2022, ContraFect Corp. (NASDAQ:CFRX) announced that the independent data safety monitoring board (DSMB) recommended that the Phase 3 DISRUPT (Direct Lysis of Staph aureus Resistant Pathogen Trial) trial of exebacase in patients with Staphylococcus aureus bacteremia, including right-sided endocarditis, be stopped for futility as the study was below the pre-specified threshold to continue. The DISRUPT trial is a randomized, double blind, placebo controlled study being conducted at over 40 centers in the U.S. that had planned to enroll approximately 350 patients randomized 2:1 to receive either exebacase or placebo, with all patients receiving standard of care antibiotics.
The DSMB's recommendation was based on the clinical response rate at Day 14 (the study's primary efficacy endpoint) in 84 patients, or approximately 60% of the total planned patient population. Patient enrollment in the trial will be stopped based on the DSMB's recommendation. The company will complete an analysis of the study data, which will inform the potential future development of exebacase. We anticipate an update from the company as soon as that analysis is complete.
The DISRUPT trial's failure is disappointing as we had not anticipated this outcome based on the data from the Phase 2 study of exebacase that showed a much higher response rate in patients treated with exebacase in addition to standard of care antibiotics compared to standard of care antibiotics alone. We will be very interested in the company's analysis of the Phase 3 data and if it can be determined what led to the unexpected outcome.
While the future of exebacase is currently unknown, ContraFect is continuing work on CF-370, the lead engineered lysin candidate targeting Pseudomonas aeruginosa and other Gram-negative bacterial species, and amurin peptides, a new class of lytic antimicrobial peptides that have shown potent in vitro activity against a wide range of Gram-negative pathogens. Earlier this year, ContraFect announced multiple presentations on CF-370 at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) Annual Meeting, which included its activity in an in vivo model and in vitro analysis of its susceptibility to resistance. A summary of those presentations can be found in our previous report.
Conclusion
We are very surprised by the negative outcome to the DISRUPT trial, particularly in light of the Phase 2 data that showed such a dramatic difference in response rate for patients treated with both exebacase and standard of care antibiotics compared to those treated only with standard of care antibiotics. We are looking forward to an update from the company after their analysis of the data is complete and the future development plans for exebacase. Due to the results of the DISRUPT trial we have removed exebacase from our model, which has decreased our valuation to $3.00.
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