Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tetrodotoxin
Halneuron · 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...
Halneuron is being developed for the treatment of chemotherapy-induced neuropathic pain, a form of nerve pain that can occur after cancer treatment. It is an investigational small molecule and has not been approved for any indication. Dogwood Therapeutics is studying it in patients with this condition.
Halneuron is being developed by Dogwood Therapeutics, Inc., a biopharmaceutical company that trades under the ticker symbol DWTX. Dogwood Therapeutics is the sponsor of the clinical program evaluating Halneuron for chemotherapy-induced neuropathic pain.
Halneuron is in Phase 2 clinical development. The ongoing trial is a Phase 2 study evaluating its efficacy and safety in chemotherapy-induced neuropathic pain. It is an investigational drug and has not received FDA approval for any indication.
Halneuron is being evaluated in a single active clinical trial, NCT06848348, titled 'Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain.' The Phase 2 trial is randomized, double-blind, and placebo-controlled, with an estimated enrollment of 240 participants. It is currently active but not recruiting, and is being conducted in the United States.
Halneuron has received Fast Track designation from the FDA for chemotherapy-induced neuropathic pain. Fast Track is intended to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need. The drug remains investigational and has not been approved.