Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as tecovirimat
ST-246 · 3 trials · 2 indications
To determine the safety and tolerability of oral tecovirimat
Number of participants with adverse events when TPOXX or TPOXX Placebo is coadministered with JYNNEOS
Least squared geometric mean
Subjects were administered a single, daily oral dose of ST-246 (400 or 600 mg)and changes in safety parameteres were monitored. Safety parameters included adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis) and electrocardiograms. The DAIDS AE grading table is a list of common terms and severity (intensity) of parameters used to describe adverse events occurring in NIAID-sponsored clinical studies/trials.
| Arm | Type | Description |
|---|---|---|
| Active | ACTIVE_COMPARATOR | 600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects |
| Placebo | PLACEBO_COMPARATOR | matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects |
| JYNNEOS + TPOXX | ACTIVE_COMPARATOR | An oral dose of 600 mg (3 × 200 mg capsules) TPOXX BID (every 12 hours \[±30 minutes\]) for 28 days and a single AM SC dose of 0.5 mL JYNNEOS on Day 1 and Day 29. JYNNEOS will be administered with TPOXX concomitantly on Day 1 |
| JYNNEOS + matching TPOXX placebo | PLACEBO_COMPARATOR | An oral dose of placebo (3 capsules identical to TPOXX) BID (every 12 hours \[±30 minutes\]) for 28 days and a single AM SC dose of 0.5 mL JYNNEOS on Day 1 and Day 29. JYNNEOS will be administered with TPOXX placebo concomitantly on Day 1. |
| ST-246 400 mg | EXPERIMENTAL | ST-246 400mg (2 x 200 mg Capsules) Orally Once Daily for 14 days |
| ST-246 600 mg | EXPERIMENTAL | ST-246 600 mg (3 x 200 mg Capsules) Orally Once Daily for 14 days |
| Name | Type | Description |
|---|---|---|
| tecovirimat | DRUG | Study is based on Animal Regulatory Rule |
| Placebo | OTHER | Does not apply |
| Smallpox and Mpox Vaccine | DRUG | vaccine |
| ST-246 400 mg | DRUG | Capsules, 400 mg daily for 14 days |
| ST-246 600 mg | DRUG | Capsules, 600 mg daily for 14 days |
Inclusion Criteria: * 18 to 80 years old, inclusive * Available for clinical follow-up for the duration of the study * Able and willing to give informed consent * In good general health without clinically significant medical history; not have been hospitalized for a chronic medical condition for th...
ST-246 is an investigational small molecule antiviral developed by SIGA Technologies Inc. (ticker: SIGA) for orthopoxviral disease. It has been studied in a Phase 2 clinical trial and is not approved; it remains in clinical development. The program's completed trial enrolled 107 participants.
ST-246 is being developed for the treatment of orthopoxviral disease, a category of viral infections that includes smallpox. Its clinical evaluation has focused on safety, tolerability, and pharmacokinetics in this indication. It is investigational and has not been approved for any use.
ST-246 is developed by SIGA Technologies Inc., which trades under the ticker SIGA. The company is the sponsor of the drug's clinical program in orthopoxviral disease.
ST-246 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA.
ST-246 has been studied in one completed Phase 2 trial, NCT00907803, titled "Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246." It was a randomized, double-blind, placebo-controlled study of 107 healthy volunteers aged 18 years and older, conducted in the United States.