Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AG10, Acoramidis
ALXN2060 · 2 trials · 2 indications
The 6MWT measures how far a participant can walk in 6 minutes. Change from baseline was calculated as the difference between the distance walked during the 6MWT at 12 months and the distance walked during the 6MWT at baseline. To determine the baseline, at least 2 6MWTs were conducted \> 24 hours to ≤ 3 weeks apart prior to the first dose of ALXN2060. The baseline 6MWT is the average of the total distance walked by participants for the 2 qualifying 6MWTs that met all the protocol-defined criteria. Least squares mean change from baseline data were adjusted for baseline measures and visits.
CV-related hospitalization was defined as the mean number of CV-related hospitalizations per participant per year over a 30-month period. CV-related hospitalizations were also reported as adverse events and were reviewed and adjudicated by an independent Clinical Events Committee (CEC).
ACM was assessed as time from the date of first initiation of study treatment to the date of death during a 30-month period, and was analyzed using Kaplan-Meier analysis. Data are reported for the number of participants with ACM over the 30-month period.
| Arm | Type | Description |
|---|---|---|
| ALXN2060 | EXPERIMENTAL | Participants will receive ALXN2060. |
| Sequence 1: Acoramidis | EXPERIMENTAL | Participants will receive acoramidis once each period as a single dose under fasted or fed conditions as follows: Period 1: Acoramidis as an immediate-release tablet under fasted conditions. Period 2: Acoramidis as an immediate-release tablet under fed conditions. There will be a washout period of at least 14 days between acoramidis dosing. |
| Sequence 2: Acoramidis | EXPERIMENTAL | Participants will receive acoramidis once each period as a single dose under fasted or fed conditions as follows: Period 1: Acoramidis as an immediate-release tablet under fed conditions. Period 2: Acoramidis as an immediate-release tablet under fasted conditions. There will be a washout period of at least 14 days between acoramidis dosing. |
| Name | Type | Description |
|---|---|---|
| ALXN2060 | DRUG | ALXN2060 tablets will be administered twice daily at a dose of 800 milligrams. |
| Acoramidis | DRUG | Film-coated immediate release oral tablet. |
Inclusion Criteria: 1. Established diagnosis of ATTR-CM with either wild-type TTR or a variant TTR genotype. 2. History of heart failure evidenced by at least 1 prior hospitalization for heart failure or clinical evidence of heart failure without prior heart failure hospitalization manifested by si...
ALXN2060 is an investigational small molecule being developed for the treatment of symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM), a condition in which abnormal protein deposits accumulate in the heart muscle and impair its function. It is currently in Phase 3 clinical development.
ALXN2060 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AZN. The drug is currently in Phase 3 clinical development for symptomatic transthyretin amyloid cardiomyopathy.
ALXN2060 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 study of ALXN2060 in Japanese participants with symptomatic transthyretin amyloid cardiomyopathy has been completed.
ALXN2060 has been studied in a Phase 3 clinical trial registered as NCT04622046, titled "A Phase 3 Study of ALXN2060 in Japanese Participants With Symptomatic ATTR-CM." This trial enrolled 25 participants in Japan and has been completed.
ALXN2060 is the drug name used in clinical development. No alternative names have been reported for this investigational compound. It is being studied for symptomatic transthyretin amyloid cardiomyopathy and is not yet approved for any use.