Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mitiperstat · 2 trials · 2 indications
COPDCompEx is a composite endpoint of exacerbations and events defined from participant e-Diaries and peak expiratory flow (PEF). COPDCompEx defined exacerbations included episodes leading to one or more of the following: hospitalization, emergency room visit, treatment with systemic corticosteroids (injected and/or oral), or treatment with antibiotics. Diary COPDCompEx events are defined by threshold and slope criteria being met for \>= 2 consecutive days using the following diary and home spirometry variables: overall symptom rating, night-time awakenings due to symptoms, reliever medication use, PEF. COPDCompEx also includes patient withdrawals for treatment failure.
The Cmax of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
The AUCinf of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
The AUClast of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
The t½λz of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
The tmax of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
The CL/F of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
The Vz/F of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
The Ae(0-24) of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
The CLR of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
The CLNR of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
The fe(0-24) of a single dose of mitiperstat in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Approximately 203 participants will be randomised to receive placebo. |
| Mitiperstat (AZD4831) | EXPERIMENTAL | Approximately 203 participants will be randomised to receive mitiperstat (AZD4831). |
| Cohort 1 | EXPERIMENTAL | 8 participants with mild hepatic impairment (Child-Pugh A) will be given Dose A of mitiperstat. |
| Cohort 2 | EXPERIMENTAL | 8 participants with moderate hepatic impairment (Child-Pugh B) will be given Dose A of mitiperstat. |
| Cohort 3 | EXPERIMENTAL | 6-8 participants with severe hepatic impairment (Child-Pugh C) will be given Dose A of mitiperstat. |
| Cohort 4 | EXPERIMENTAL | 8-12 participants with normal hepatic function will be given Dose A of mitiperstat. |
| Name | Type | Description |
|---|---|---|
| Mitiperstat (AZD4831) | DRUG | Oral dosage, once daily. |
| Placebo | OTHER | Oral dosage, once daily. |
| Mitiperstat | DRUG | Participants receive mitiperstat orally. |
Inclusion Criteria: * Provision of informed consent. * Participants must be deemed as high risk of exacerbations as defined by: \>= 1 moderate or severe exacerbation in the previous 24 months; or frequent productive cough; or post-bronchodilator (BD) forced expiratory volume in the first second (FE...
Mitiperstat is an investigational small molecule being studied for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD). It is also being evaluated in patients with hepatic impairment to assess its pharmacokinetics. The drug is not approved and remains in clinical development.
Mitiperstat is a myeloperoxidase (MPO) inhibitor, as indicated by its trial title. It works by inhibiting the MPO enzyme, which is involved in inflammatory processes relevant to COPD. This mechanism is being investigated for its potential to reduce disease progression.
Mitiperstat is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in respiratory and hepatic conditions.
Mitiperstat is in Phase 2 clinical development for chronic obstructive pulmonary disease (COPD). A Phase 1 study in hepatic impairment has also been completed. The drug is investigational and has not received FDA approval for any indication.
Mitiperstat has one completed Phase 2 trial, NCT05492877, which evaluated its efficacy and safety versus placebo in 381 patients with moderate to severe COPD across multiple countries. A separate Phase 1 trial, NCT05751759, assessed its pharmacokinetics in 31 participants with hepatic impairment.
Yes, Mitiperstat is also known as AZD4831. The Phase 2 COPD trial explicitly refers to Mitiperstat (AZD4831) as an MPO inhibitor, confirming that both names refer to the same investigational drug being developed by AstraZeneca.