Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Niclosamide · 2 trials · 2 indications
Incidence of Treatment Emergent Adverse Events (TEAEs)
Incidence of Treatment Emergent Serious Adverse Events (TESAEs)
Number of Subjects Reporting treatment-emergent AEs (TEAEs) and Serious treatment-emergent AEs (STEAEs) in the SAD
Number of Subjects Reporting treatment-emergent AEs (TEAEs) and Serious treatment-emergent AEs (STEAEs) in the MAD
Number of Subjects with Clinically Significant changes in ECG parameters from Baseline (PR, QRS, QT, and QTc intervals)
Number of Subjects with Clinically Significant changes in ECG parameters from Baseline (PR, QRS, QT, and QTc intervals)
Number of Subjects with Clinically Significant changes in Haematology (Basophils (%),Eosinophils (%, Ery. Mean Corpuscular Hemoglobin, Ery. Mean Corpuscular Volume, Erythrocytes (10\^12/L), Hematocrit (%), Hemoglobin (g/dL). Hemoglobin (g/dL), Lymphocytes (%), Monocytes (%), Neutrophils (%)' Platelets (10\^9/L), Reticulocytes (%))
Number of Subjects with Clinically Significant changes in Haematology (Basophils (%),Eosinophils (%, Ery. Mean Corpuscular Hemoglobin, Ery. Mean Corpuscular Volume, Erythrocytes (10\^12/L), Hematocrit (%), Hemoglobin (g/dL). Hemoglobin (g/dL), Lymphocytes (%), Monocytes (%), Neutrophils (%)' Platelets (10\^9/L), Reticulocytes (%))
Number of Subjects with Clinically Significant changes in Serum Chemistry (Alanine Aminotransferase (U/L), Alkaline Phosphatase (U/L), Aspartate Aminotransferase (U/L), Bilirubin (mg/dL), Calcium (mg/dL), Creatinine (mg/dL), Direct Bilirubin (mg/dL, Glucose (mg/dL), Potassium (mmol/L), Protein (g/dL), Sodium (mmol/L), Urea Nitrogen (mg/dL)
Number of Subjects with Clinically Significant changes in Serum Chemistry (Alanine Aminotransferase (U/L), Alkaline Phosphatase (U/L), Aspartate Aminotransferase (U/L), Bilirubin (mg/dL), Calcium (mg/dL), Creatinine (mg/dL), Direct Bilirubin (mg/dL, Glucose (mg/dL), Potassium (mmol/L), Protein (g/dL), Sodium (mmol/L), Urea Nitrogen (mg/dL)
Number of Subjects with Clinically Significant changes in Urinalysis (Specific Gravity, Urobilinogen (EU), pH)
Number of Subjects with Clinically Significant changes in Urinalysis (Specific Gravity, Urobilinogen (EU), pH)
Number of Subjects with Clinically Significant changes in Vital Signs from Baseline (Diastolic Blood Pressure, Systolic Blood Pressure (mmHg), Pulse Rate (beats/min), Respiratory Rate (breaths/min))
Number of Subjects with Clinically Significant changes in Vital Signs from Baseline (Diastolic Blood Pressure, Systolic Blood Pressure (mmHg), Pulse Rate (beats/min), Respiratory Rate (breaths/min))
| Arm | Type | Description |
|---|---|---|
| ANA001 | EXPERIMENTAL | Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding. |
| Matching Placebo | PLACEBO_COMPARATOR | Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration. |
| SAD Cohort 1: ANA001 1000 mg po | EXPERIMENTAL | Subjects will receive a 1000 mg single oral dose of ANA001 with a standardized light meal presented at 4 x 250 mg capsules. Each capsule is 250 mg. |
| SAD Cohort 2: ANA001 2000 mg po | EXPERIMENTAL | Subjects will a 2000 mg single oral dose of ANA001 with a standardized light meal presented at 8 x 250 mg capsules. Each capsule is 250 mg. |
| SAD Cohort 3: ANA001 3000 mg po | EXPERIMENTAL | Subjects will a 3000 mg single oral dose of ANA001 with a standardized light meal presented at 12 x 250 mg capsules. Each capsule is 250 mg. |
| SAD Cohorts 1, 2 & 3: Pooled Matching Placebo | PLACEBO_COMPARATOR | Subjects will receive matching placebo hydroxypropylmethylcellulose (HPMC) as a single oral dose (4, 8, or 12 capsules) with a standardized light meal. |
| MAD Cohort 1: ANA001 1000 mg po BID | EXPERIMENTAL | Subjects will receive an oral dose of 1000mg ANA001 twice daily (BID) with a standardized light meal for 7 consecutive days. Each dose will be presented as 4 250mg capsules. |
| MAD Cohort 2: ANA001 1000 mg po TID | EXPERIMENTAL | Subjects will receive an oral dose of 1000mg ANA001 three times daily (TID) with a standardized light meal for 7 consecutive days. Each dose will be presented as 4 250mg capsules. |
| MAD Cohorts 1 & 2: Pooled Matching Placebo | PLACEBO_COMPARATOR | Subjects will receive an oral dose of matching Placebo to ANA001 two (BID) three times daily (TID) with a standardized light meal for 7 consecutive days. Each dose will be presented as 4 250mg capsules of hydroxypropylmethylcellulose (HPMC) |
| Name | Type | Description |
|---|---|---|
| Niclosamide | DRUG | Niclosamide is an antihelmintic with in-vitro antiviral activity |
| Placebo | DRUG | Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients |
Key Inclusion Criteria: 1. Provide written informed consent prior to performing study procedures 2. Hospitalized. 3. Male or female ≥18 years of age 4. Positive for severe acute respiratory syndrome coronavirus 2 5. Presence of symptoms of lower respiratory tract infection (LRTI) including at least...
Niclosamide is an investigational small molecule being studied for COVID-19. It has been evaluated in a Phase 2 trial in moderate and severe hospitalized COVID-19 patients, and in a Phase 1 trial in healthy volunteers. It is not approved for any use.
Niclosamide is being developed by MetaVia Inc. (NASDAQ: MTVA). The company has conducted clinical trials of the drug in the United States.
Niclosamide has completed a Phase 2 trial for COVID-19 and a Phase 1 trial in healthy volunteers. Both trials are completed, and the drug remains investigational, not approved by the FDA.
Niclosamide has been studied in two completed trials: NCT04603924, a Phase 2 study in moderate and severe hospitalized COVID-19 patients, and NCT04705415, a Phase 1 single and multiple ascending dose study in healthy volunteers. Both were conducted in the United States.
Niclosamide is a distinct small molecule being investigated for COVID-19. It has been tested in a randomized, double-blind, placebo-controlled Phase 2 trial in hospitalized patients, but no alternative names for the drug have been reported.