Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ALXN1840, WTX101, Tiomolibdate choline, ALXN1840 Enteric-coated Tablet, WTX101 (formerly), ALXN1840 Non-coated Capsule, Formerly named WTX101, Tiomolibdic acid
Bis-Choline Tetrathiomolybdate · 6 trials · 1 indication
Liver biopsy samples were taken for the assessment of liver Cu concentration. Multiple imputation was used to impute missing data at Week 48 due to any reason based on Baseline values.
Copper balance is defined as the difference between the measured copper input in food and drink, and the measured copper elimination in urine and feces, and was calculated as the average daily copper balance over the collection period.
Copper balance is defined as the difference between the measured copper input in food and drink, and the measured copper elimination in urine and feces, and was calculated as the average daily copper balance over the collection period.
Copper balance is defined as the difference between the measured copper input in food and drink, and the measured copper elimination in urine and feces, and was calculated as the average daily copper balance over the collection period.
Copper balance is defined as the difference between the measured copper input in food and drink, and the measured copper elimination in urine and feces, and was calculated as the average daily copper balance over the collection period.
Normalized concentrations of NCC was defined as who achieving or maintaining normalized levels of NCC (0.8 to 2.3 micromole \[μmol\]l/liter \[L\]\]) adjusted for Mo plasma concentration or reaching a reduction of at least 25% in NCC corrected for Mo if above the normal reference range at the time of enrollment. NCC was calculated by subtracting the amount of copper (Cu) bound to ceruloplasmin (CP) from the total plasma Cu concentration. Post-baseline NCC values were adjusted (corrected) to account for Cu bound in tripartite complexes with ALXN1840 and albumin. Descriptive statistics are reported.
Blood samples were collected for pharmacokinetics (PK) analysis of celecoxib. Cmax is reported as nanograms (ng)/milliliter (mL).
Blood samples were collected for pharmacokinetic (PK) analysis of celecoxib. Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Last Quantifiable Concentration (AUCt) is reported as hours•ng/mL (h•ng/mL).
Blood samples were collected for pharmacokinetic (PK) analysis of celecoxib. Area Under The Plasma Concentration Versus Time Curve From Time 0 To Infinity (AUCinf) is reported as h•ng/mL.
| Arm | Type | Description |
|---|---|---|
| ALXN1840 | EXPERIMENTAL | Participants will receive ALXN1840. |
| Treatment A | EXPERIMENTAL | Participants will receive bupropion. |
| Treatment B | EXPERIMENTAL | Participants will receive bupropion with ALXN1840. |
| Treatment Sequence A-B | EXPERIMENTAL | Participants received 1 treatment during each study period in the following sequence: * Treatment A: Celecoxib. * Treatment B: Celecoxib plus ALXN1840. |
| Treatment Sequence B-A | EXPERIMENTAL | Participants received 1 treatment during each study period in the following sequence: * Treatment B: Celecoxib plus ALXN1840. * Treatment A: Celecoxib. |
| Cohort 1: Japanese Participants | EXPERIMENTAL | All Japanese participants will receive a single dose of ALXN1840 15 milligrams (mg) in Dosing Period 1 and will receive a single dose of ALXN1840 60 mg in Dosing Period 2. |
| Cohort 2: Non-Japanese Participants | EXPERIMENTAL | All non-Japanese participants will receive a single dose of ALXN1840 15 mg in Dosing Period 1 and will receive a single dose of ALXN1840 60 mg in Dosing Period 2. |
| Name | Type | Description |
|---|---|---|
| Bis-Choline Tetrathiomolybdate | DRUG | Participants will be initiated at 15 milligrams once daily, then the dose will be increased to 30 milligrams once daily at Week 6. |
| ALXN1840 | DRUG | Administered orally as tablets. |
| Bupropion Hydrochloride | DRUG | Bupropion hydrochloride will be administered orally as a single dose as one 150 milligrams (mg) tablet with 240 milliliters of water (fasting). |
| Celecoxib | DRUG | Celecoxib was administered orally as a single dose as one 200-mg tablet with 240 mL of water (fasting). |
Inclusion Criteria: 1. Diagnosis of WD by Leipzig Criteria ≥ 4 or by historical test results. 2. Continuous treatment for WD with penicillamine, trientine or zinc for at least 1 year prior to screening. 3. Body mass index \< 30 kilograms/meter squared. 4. Able to cooperate with a percutaneous liver...
Bis-Choline Tetrathiomolybdate is an investigational small molecule being developed for the treatment of Wilson Disease, a rare genetic disorder of copper metabolism. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Bis-Choline Tetrathiomolybdate is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is in Phase 2 clinical development for Wilson Disease.
Bis-Choline Tetrathiomolybdate is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. A Phase 2 clinical trial for Wilson Disease has been completed.
Bis-Choline Tetrathiomolybdate has one completed Phase 2 clinical trial, identified as NCT04422431. This trial, titled 'Copper Concentration & Histopathologic Changes in Liver Biopsy in Participants With Wilson Disease Treated With ALXN1840,' enrolled 31 participants across multiple countries including the United States, Canada, Denmark, New Zealand, Russia, Singapore, Spain, and the United Kingdom.
Yes, Bis-Choline Tetrathiomolybdate is also known as ALXN1840. The completed Phase 2 clinical trial NCT04422431 for Wilson Disease used the name ALXN1840 in its title, confirming that these names refer to the same investigational drug.