Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TRX-100 · 4 trials · 3 indications
Defined as at least 2 quantifiable (≥LLOQ) qRT-PCR samples reported over 4 planned consecutive assessments within 48 hours.
At least one incidence of a symptom from the symptom diary card of grade ≥2.
Number of participants with Adverse Events (AEs), serious Adverse Events (SAEs) (including withdrawals due to AEs)
Number of participants with abnormal laboratory tests results
Number and percentage of participants with treatment-emergent adverse events, summarized by severity and relationship to study drug.
Number and percentage of participants with serious adverse events and adverse events leading to discontinuation from the study.
Incidence, severity and relationship of AEs/serious AEs (SAEs) (including withdrawals due to AEs)
Change from baseline in QT interval (miliseconds)
| Arm | Type | Description |
|---|---|---|
| TRX-100 Timing 1 | EXPERIMENTAL | Participants in this arm will receive single oral dose of the investigational drug, TRX-100. |
| TRX-100 Timing 2 | EXPERIMENTAL | Participants in this arm will receive single oral dose of the investigational drug, TRX-100. |
| TRX-100 Timing 3 | EXPERIMENTAL | Participants in this arm will receive single oral dose of the investigational drug, TRX-100. |
| TRX-100 Timing 4 | EXPERIMENTAL | Participants in this arm will receive single oral dose of the investigational drug, TRX-100. |
| Placebo Timing 1 | PLACEBO_COMPARATOR | Participants in this arm will receive single oral dose of the Placebo. |
| Placebo Timing 2 | PLACEBO_COMPARATOR | Participants in this arm will receive single oral dose of the Placebo. |
| Placebo Timing 3 | PLACEBO_COMPARATOR | Participants in this arm will receive single oral dose of the Placebo. |
| Placebo Timing 4 | PLACEBO_COMPARATOR | Participants in this arm will receive single oral dose of the Placebo. |
| TRX-100 Dose Level 1 | EXPERIMENTAL | Participants in this arm will receive a lower single oral dose of the investigational drug, TRX-100. |
| TRX-100 Dose Level 2 | EXPERIMENTAL | Participants in this arm will receive a higher single oral dose of the investigational drug, TRX-100. |
| Standard of Care (SOC) | ACTIVE_COMPARATOR | Participants in this arm will not receive the investigational drug. Instead, they will receive the current standard of care treatment. This arm serves as a comparator to evaluate the effects of the investigational drug. |
| Cohort A: 240 mg tablets, fed | EXPERIMENTAL | Up to 8 healthy volunteers will be randomized 6:2 to receive a single oral dose of TRX-100 240 mg tablets or matching tablet placebo, respectively, under fed conditions. |
| Cohort B: 480 mg tablets, fasted | EXPERIMENTAL | Up to 8 healthy volunteers will be randomized 6:2 to receive a single oral dose of TRX-100 480 mg tablets or matching tablet placebo, respectively, under fasted conditions. |
| Cohort C: 480 mg tablets, fed | EXPERIMENTAL | Up to 8 healthy volunteers will be randomized 6:2 to receive a single oral dose of TRX-100 480 mg tablets or matching tablet placebo, respectively, under fed conditions. Dosing will begin only after Safety Review Committee review of available blinded safety data and initial pharmacokinetic data from Cohort A. |
| Cohort D: 480 mg capsules, fed | EXPERIMENTAL | Up to 8 healthy volunteers will be randomized 6:2 to receive a single oral dose of TRX-100 480 mg capsules or matching capsule placebo, respectively, under fed conditions. Dosing will begin after completion of Cohort C. |
| Single dose level 1 or placebo | EXPERIMENTAL | SAD dose level 1 |
| Single dose level 2 or placebo | EXPERIMENTAL | SAD dose level 2 |
| Single dose level 3 or placebo | EXPERIMENTAL | SAD dose level 3 |
| Single dose level 4 or placebo | EXPERIMENTAL | SAD dose level 4 |
| Name | Type | Description |
|---|---|---|
| TRX-100 | DRUG | A single oral dose in capsules |
| Placebo | DRUG | A single oral dose in capsules |
| Influenza A/France/759/2021 (H1N1) virus | BIOLOGICAL | A single dose of challenge agent will be delivered Intranasal |
| Standard of Care (SOC) | DRUG | Standard of Care Influenza Antiviral therapy |
Inclusion Criteria: 1. Written informed consent signed and dated by the participant and the PI/investigator obtained before any assessment is performed. 2. Aged between 18 and 55 years old on the day prior to signing the consent form, inclusive. 3. A total body weight ≥50 kg and body mass index (BM...
TRX-100, also known as tivoxavir marboxil, is an investigational small molecule being developed for the treatment of influenza. It is currently being studied in healthy volunteers and in patients with mild to moderate influenza, including a human influenza A challenge model.
TRX-100 targets the CAP-dependent endonuclease, a protein essential for influenza virus replication. By inhibiting this enzyme, the drug aims to block viral replication and reduce the severity and duration of influenza infection.
TRX-100 is being developed by Traws Pharma, Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol TRAW. The company is conducting clinical trials of TRX-100 in Australia and the United Kingdom.
TRX-100 is in Phase 2 clinical development. It has completed a Phase 1 study in healthy volunteers and is currently being evaluated in Phase 2 trials for influenza, including a human challenge model study. It is not yet approved by regulatory authorities.
TRX-100 is being studied in several clinical trials. NCT06757738 is a completed Phase 1 study in healthy volunteers. NCT07371650 is an active Phase 2 trial in patients with mild to moderate influenza. NCT07503405 is a planned Phase 2a human influenza challenge study, and NCT07526506 is a recruiting Phase 1 study in healthy volunteers.
Yes, TRX-100 is also known as tivoxavir marboxil. The drug is referred to by both names in clinical trial documentation, with TRX-100 being the investigational code name and tivoxavir marboxil the proposed generic name.