Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 5% Nu-3 gel, 5% Nu-3, 10% Nu-3 gel, 10% Nu-3, Antimicrobial agent, Bisphosphocin Nu-3
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...
Nu-3 is being developed for diabetic foot infection and diabetic foot ulcers (DFUs). It is a small molecule therapeutic candidate studied in adults aged 18 years and older. The clinical program focuses on infected diabetic foot ulcers, a complication of diabetes in which foot wounds become infected and are slow to heal.
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 Nu-3 gel in patients with diabetic foot infection and diabetic foot ulcers. No other developer or partner is associated with the asset.
Nu-3 is in Phase 2 clinical development. It has not been approved by the FDA and remains an investigational therapy. Two Phase 2 trials are registered, both currently listed as not yet recruiting, and no completed trials of Nu-3 have been reported to date.
Nu-3 is being studied in two Phase 2 trials. NCT06020235 is titled Nu-3 Gel for Infected Diabetic Foot Ulcers and is designed to enroll 60 participants. NCT07565506 is a Phase 2a dose finding study of Nu-3 gel in subjects with mild infected diabetic foot ulcers and is designed to enroll 24 participants.
The Nu-3 Phase 2 program uses randomized, double-blind, placebo-controlled designs. Participants are adults 18 years and older, and healthy volunteers are not eligible. The trials enroll patients with diabetic foot infection or diabetic foot ulcers, and the Phase 2a study evaluates dose finding in mild infected diabetic foot ulcers.
Yes. Nu-3 is also known as 5% Nu-3 gel, 5% Nu-3, 10% Nu-3 gel, and 10% Nu-3, and it has been described as an antimicrobial agent. These names refer to the same investigational small molecule developed by Lakewood-Amedex Biotherapeutics, formulated as a topical gel at different concentrations.