Table 2.
Clinical trials of phage lytic enzymes.
| Descriptor | Company | Type | Route | Phase | # | Start | Status | Registry # | Protocol and Observations | Ref. |
|---|---|---|---|---|---|---|---|---|---|---|
| P128 (StaphTAME) |
GangaGen | Ectolysin | IN | I/II | 74 | 2012 | Completed | NCT01746654 | Type: randomized, double-blind, placebo-controlled study; goal: (1) evaluation of safety, tolerability via single or multiple doses (3 doses/day for 5 days) of 0.1 mg, 0.3 mg, and 1mg concentrations of P128, administrated intranasally to healthy individuals; (2) evaluation of safety, tolerability, and efficacy of P128 in chronic kidney disease patients or any patients who are nasal carriers of S. aureus or MRSA strain with single dose or 3 escalating concentrations of P128; Initial results: drug was well tolerated; results: reduction of nasal carriage |
NA |
| N-Rephasin® SAL200 (SAL-1, tonabacase) |
iNtRON Biotechnology | Endolysin | IV | I | 36 | 2013 | Completed | NCT01855048 | Type: randomized, double-blind, placebo-controlled study; goal: evaluation of safety, pharmacokinetics, and pharmacodynamics of single intravenous dose of SAL-1 at various concentrations: 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg, administrated to healthy male individuals; results: no severe side effects observed |
[157] |
| II | 25 | 2017 | Terminated 1 | NCT03089697 | Type: randomized, double-blind, placebo-controlled study; goal: evaluation of safety and efficacy of SAL-1 (3mg/kg), administrated once a day intravenously to individuals with persistent S. aureus bacteremia; results: serious adverse effects occurred (2/12 patients, 16.67% of test group), including pneumonia (one patient, 8.33% of test group) and respiratory failure (one patient, 8.33% of test group), as well as several other minor adverse events (10/12 patients, 83.33% of the test group), e.g., anemia, chills, back pain, headache, gastrointestinal disorders |
NA | ||||
| Lysin CF-301 (PlySs2, exebacase) | ContraFect | Endolysin | IV | I | 20 | 2015 | Completed | NCT02439359 | Type: placebo-controlled, dose-escalating study; goal: evaluation of safety and tolerability of single intravenous dose of CF-301; healthy male and female individuals; results: CF-301 has a safe profile with no side effects observed |
[266,267,268,269,270] |
| II | 121 | 2017 | Completed | NCT03163446 | Type: multicenter, randomized, double-blind, placebo-controlled study; goal: evaluation of safety, tolerability, efficacy, and pharmacokinetics of CF-301; study performed in addition to standard-of-care antibacterial therapy; adult individuals with bloodstream infections (bacteremia), including endocarditis |
[325] | ||||
| III | 348 | 2019 | Ongoing | NCT04160468 | Type: randomized, double-blind, placebo-controlled study; goal: evaluation of the efficacy and safety of a single dose of Exebacase in addition to standard-of-care antibacterial therapy; adult individuals with bloodstream infections (bacteremia), including endocarditis |
NA | ||||
| Staphefekt SA.100 | Micreos | Endolysin | T | I/II 1 | 100 | 2016 | Completed | NCT02840955 | Goal: evaluation on disease severity and skin microbiome; individuals with atopic dermatitis; results: no side effects observed, decrease in bacterial burden | [189] |
Abbreviations: (#) number of participants, (IN) intranasally, (IP) interperitoneally, (IV) intravenously, (T) topically, (NA) not available. 1 Enrollment into this study was terminated by the sponsor prior to completion of the study.