Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Nu-3
Bisphosphocin Nu-3 · 3 trials · 3 indications
The rate reduction in CFUs by ≥ 2 logs per pathogen, which is identified as typical and highly suspicious for being the cause of the infection compared to baseline.
Number of AEs overall and those assessed by the investigators as possibly, probably, and definitely related to the study drug as well as the number of SAEs per patient and cohort.
Number of AEs overall and those assessed by the investigators as possibly, probably, and definitely related to the study drug; number of SAEs per patient and cohort
The rate of reduction in CFUs by \>=2 logs per pathogen identified as typical and highly suspicious for being the cause of the infection, in each treatment group compared to placebo group at Day 7 compared to Day 0, and Day 14 compared to Day 0.
The severity of each adverse event, as judged by the investigator, was graded according to the CTCAE v4.02. Treatment-emergent adverse events are defined as adverse events with onset times after dosing, or pre-existing adverse events that worsened during the study.
The microbiological response to bisphosphocin Nu-3 based on aerobic and anaerobic culture and sensitivity was determined by measuring the reduction of pathogenic bacteria following Nu-3 treatment. Each laboratory used their own standards to decide whether the cultures were normal or abnormal.
| Arm | Type | Description |
|---|---|---|
| 2.5mg dose | EXPERIMENTAL | Twice daily application for 14 days |
| 5mg dose | EXPERIMENTAL | Twice daily application for 14 days |
| 10mg dose | EXPERIMENTAL | Twice daily application for 14 days |
| 5% Nu-3 gel once daily | EXPERIMENTAL | The 5% Nu-3 gel is applied once per day and placebo is applied once per day. |
| 5% Nu-3 gel twice daily | EXPERIMENTAL | The 5% Nu-3 gel is applied twice per day. |
| 10% Nu-3 gel once daily | EXPERIMENTAL | The 10% Nu-3 gel is applied once per day and placebo is applied once per day. |
| 10% Nu-3 gel twice daily | EXPERIMENTAL | The 10% Nu-3 gel is applied twice per day. |
| Placebo | PLACEBO_COMPARATOR | The placebo is applied twice per day. |
| Bisphosphocin Nu-3 | EXPERIMENTAL | Dosage Form: Topical Antimicrobial, Dosage: 1mg/mL, 10 mg/mL, 20 mg/mL, 50 mg/mL, 100 mg/mL Frequency: QD for day 1, 2x daily for 7 days, Duration: 8 days |
| Name | Type | Description |
|---|---|---|
| Antimicrobial agent | DRUG | Topical antimicrobial gel application twice a day for 2 weeks |
| 5% Nu-3 gel | DRUG | The gel is called Nu-3 which is either applied once per day or twice per day to the infected ulcer. |
| 10% Nu-3 gel | DRUG | The gel is called Nu-3 which is either applied once per day or twice per day to the infected ulcer. |
| Placebo | DRUG | Placebo gel is either applied once per day or twice per day to the infected ulcer. |
| Bisphosphocin Nu-3 | DRUG | - |
Inclusion Criteria: 1. Male and female subjects ≥18 years of age. 2. Voluntary written informed consent, including information about the provisions of the Health Insurance Portability and accountability act (HIPAA) as applicable. 3. Non-hospitalized ambulatory subjects diagnosed with diabetes melli...
Bisphosphocin Nu-3 is being developed for diabetic foot infections, specifically for topical application on infected diabetic ulcers in people with Type I or Type II diabetes mellitus. It is an investigational small molecule therapeutic and has not been approved for commercial use.
Bisphosphocin Nu-3 is being developed by Lakewood-Amedex Biotherapeutics Inc., which trades under the ticker LABT. The company is the sponsor of the clinical program evaluating the drug in diabetic foot infections.
Bisphosphocin Nu-3 is in Phase 1 clinical development. The program has completed one Phase 1 trial, and no active trials are currently listed. It remains an investigational therapy and is not FDA approved.
Bisphosphocin Nu-3 has been evaluated in one completed Phase 1 trial, NCT02737722, titled Topically Applied Bisphosphocin Nu-3 on Infected Diabetic Ulcers of Subjects With Type I or II Diabetes Mellitus. The trial enrolled 31 participants in the United States and was randomized, double-blind, and placebo-controlled.
The Phase 1 trial NCT02737722 was a randomized, double-blind, placebo-controlled study of topically applied Bisphosphocin Nu-3 on infected diabetic ulcers in subjects with Type I or II diabetes mellitus. It enrolled 31 participants aged 18 years and older in the United States and has been completed.