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Label indication ATTRUBY is indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization. FDA label
Also known as ALXN2060, AG10
Acoramidis · 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...
Acoramidis is an investigational small molecule developed by AstraZeneca PLC (ticker AZN). It is a transthyretin (TTR) stabiliser that has been studied in Phase 1 clinical development. Its therapeutic indications have not been disclosed, and the completed early-stage work focused on healthy adult volunteers rather than patients with a named disease.
Acoramidis targets transthyretin, also known as TTR. It belongs to the TTR stabiliser class, meaning it is designed to bind and stabilise the transthyretin protein. AstraZeneca PLC (ticker AZN) is developing this small molecule, which has completed a Phase 1 study in healthy adult participants.
Acoramidis is developed by AstraZeneca PLC, which trades under the ticker AZN. The company is the sponsor behind the drug's clinical program. AstraZeneca has advanced acoramidis through Phase 1 testing, with one completed trial conducted in the United States involving healthy adult volunteers.
Acoramidis is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active. The program enrolled 18 participants in total, all healthy adults, and the study was randomized and controlled.
Acoramidis has been studied in one completed Phase 1 trial, NCT04958135, titled a study to assess the effect of food on a single dose of acoramidis in healthy adult participants. That trial enrolled 18 healthy volunteers aged 18 years and older in the United States and is now completed.
Acoramidis is a distinct TTR stabiliser developed by AstraZeneca PLC under the ticker AZN. It should not be confused with other transthyretin-directed therapies, which are separate molecules with their own developers and clinical programs. Acoramidis itself has completed one Phase 1 trial, NCT04958135, in healthy adult participants.