Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Halneuron, TTX
Tetrodotoxin · 4 trials · 6 indications
Change from Baseline in the weekly average of daily 24-hour pain intensity scores analyzed by percentage of responders among patients treated with Halneuron compared to Placebo
Incidence of serious adverse events (SAEs), adverse events (AEs) and Adverse Events of Special Interests (AESIs)
The primary cardiodynamic endpoint was the effect of TTX plasma concentrations on the QTc interval using linear mixed-effect exposure-response modeling, including the predicted ddQTc at Cmax values corresponding to exposure levels of interest.
| Arm | Type | Description |
|---|---|---|
| Tetrodotoxin | EXPERIMENTAL | There is only one arm; active treatment with TTX |
| Sugar injection | PLACEBO_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Halneuron | EXPERIMENTAL | Halneuron |
| Open Label Extension | ACTIVE_COMPARATOR | Subjects may choose to continue in an Open Label Extension (OLE) phase if they complete the randomized phase. All subjects regardless of treatment assignment in the randomized phase will receive Halneuron, during the OLE phase of the study, if offered by the clinical site. |
| Treatment Arm | EXPERIMENTAL | (Period 1) A single TTX dose of 15 μg (0.5 mL of TTX 30 μg/mL injection solution) administered as 1 SC injection with a single oral moxifloxacin matching placebo (1 x placebo tablet) (Period 2) A single TTX dose of 30 μg (1 mL of TTX 30 μg/mL injection solution) administered as 1 SC injection with a single oral moxifloxacin matching placebo (1 x placebo tablet) (Period 3) A single TTX dose of 45 μg (1.5 mL of TTX 30 μg/mL injection solution) administered as 2 SC injections with a single oral moxifloxacin matching placebo (1 x placebo tablet) |
| Control | PLACEBO_COMPARATOR | Treatment D: (Period 1)A single matching-TTX placebo administered with a single oral moxifloxacin matching placebo Treatment E: (Period 2)A single matching-TTX placebo with a single oral 400 mg moxifloxacin Treatment F: (Period 3)A single matching-TTX placebo with a single oral moxifloxacin matching placebo Treatment G: (Period 1)A single matching-TTX placebo with a single oral 400 mg moxifloxacin Treatment H: (Period 2)A single matching-TTX placebo with a single oral moxifloxacin matching placebo Treatment I: (Period 3)A single matching-TTX placebo with a single oral 400 mg moxifloxacin |
| Name | Type | Description |
|---|---|---|
| Tetrodotoxin | BIOLOGICAL | 30 µg twice daily for 4 days; repeated every two weeks as long as there is a meaningful analgesic response |
| Placebo | BIOLOGICAL | 2 mL subcutaneous injection twice daily for 4 days |
| Halneuron | DRUG | Halneuron for Subcutaneous Injection |
| Halneuron (Open Label Extension) | DRUG | Halneuron for Subcutaneous Injection |
| Placebos | DRUG | matching placebo comparator |
Inclusion Criteria: All patients who participated in the TEC-006 study (tetrodotoxin and placebo-treated) will be eligible for inclusion in this study provided they wish to continue to receive treatment and meet the inclusion and exclusion criteria. NOTE: The blinded treatment assignment of patien...
Tetrodotoxin is being developed for the treatment of moderate to severe cancer-related pain that is inadequately controlled. It has also been studied in a dedicated cardiac safety trial known as a TQT study, which assessed its cardiovascular effects in healthy adult volunteers.
Tetrodotoxin is being developed by Dogwood Therapeutics, Inc., which trades under the ticker DWTX. The company has sponsored clinical studies of the drug in cancer-related pain and in a cardiac safety setting.
Tetrodotoxin has reached Phase 3 clinical development. Two completed Phase 3 trials evaluated subcutaneous Tetrodotoxin in patients with moderate to severe inadequately controlled cancer-related pain, and a separate Phase 1 cardiovascular study has also been completed. It remains an investigational drug.
Tetrodotoxin has been studied in completed trials including NCT00725114, a Phase 3 safety and efficacy study of subcutaneous Tetrodotoxin for cancer-related pain, and its open-label continuation study NCT00726011. A Phase 1 cardiovascular study, NCT04083833, evaluated its effect in healthy adult subjects.
Across the reported Tetrodotoxin studies, total enrollment was 278 participants. The Phase 3 cancer pain study NCT00725114 enrolled 165 patients, the open-label continuation study NCT00726011 enrolled 113 patients, and the Phase 1 cardiovascular study NCT04083833 enrolled 25 healthy adult volunteers.
Yes. The Tetrodotoxin clinical program included randomized, double-blind, placebo-controlled designs. The Phase 1 cardiovascular study NCT04083833 was randomized, double-blind, and included both placebo and positive controls, while the Phase 3 cancer pain studies used randomized, double-blind, placebo-controlled methodology.