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Also known as Alvelestat oral tablet - dose 1, Alvelestat, Alvelestat (MPH966)
Alvelestat- dose 1 · 3 trials · 7 indications
To evaluate the effect of alvelestat (MPH966) administered twice daily (bid) for 12 weeks on blood markers of within-individual % change in plasma desmosine/isodesmosine will be measured.
To evaluate the safety and tolerability of alvelestat (MPH966) administered twice daily (bid) for 12 weeks treatment numbers and % of subjects who experience at least 1 treatment-emergent adverse event (TEAE) will be measured.
Within-individual change from baseline up to end of treatment in: * Blood neutrophil elastase activity * Blood Aα-Val 360 levels * Plasma desmosine/isodesmosine levels
| Arm | Type | Description |
|---|---|---|
| Alvelestat (MPH966) | ACTIVE_COMPARATOR | Alvelestat (MPH966) 120mg (4 30mg tablets) twice daily by mouth for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | 4 Placebo tablets twice daily by mouth for 12 weeks |
| Placebo oral tablet | PLACEBO_COMPARATOR | - |
| Alvelestat oral tablet - dose 1 | ACTIVE_COMPARATOR | MPH966 |
| Alvelestat oral tablet - dose 2 | ACTIVE_COMPARATOR | MPH966 |
| Alvelestat oral tablet - dose 3 | ACTIVE_COMPARATOR | MPH966 |
| Name | Type | Description |
|---|---|---|
| Alvelestat (MPH966) | DRUG | Alvelestat was developed as treatment for lung diseases like Chronic Obstructive Pulmonary Disease. Alevelestat works by blocking certain proteins in the body that are responsible for inflammation and damage to the lungs that can lead to COPD symptoms. |
| Placebo | OTHER | Placebo is a pill or tablet that does not contain any study drug. |
| Placebo Oral Tablet | DRUG | twice daily administration |
| Alvelestat oral tablet - dose 1 | DRUG | twice daily administration |
| Alvelestat oral tablet - dose 2 | DRUG | twice daily administration |
| Alvelestat | DRUG | oral tablet |
Inclusion Criteria: Participants are eligible to be included in the study only if ALL of the following criteria apply: 1. Capable of giving signed informed consent as described in Appendix 3, which includes compliance with the requirements and restrictions listed in the informed consent form and i...
Alvelestat is an investigational oral small molecule being studied for alpha 1-antitrypsin deficiency, a rare genetic condition associated with emphysema and COPD, and it has also been studied in COVID-19. It is in Phase 2 clinical development and is not described as approved for any use.
Alvelestat targets ELANE, also known as neutrophil elastase, and acts as an inhibitor of this enzyme. By inhibiting neutrophil elastase, the drug is designed to address the protease imbalance associated with alpha 1-antitrypsin deficiency, where low or impaired AAT leaves elastase activity insufficiently controlled in the lung.
Alvelestat is developed by Mereo BioPharma Group plc, which trades under the ticker MREO. The company has advanced the oral small molecule through Phase 2 studies in alpha 1-antitrypsin deficiency and a Phase 1 study in COVID-19.
Alvelestat is in Phase 2 clinical development and remains investigational. Its completed studies include a Phase 2 trial in alpha 1-antitrypsin deficiency and a Phase 1 safety and tolerability study in COVID-19. The program has received Orphan Drug and Fast Track designations from the FDA.
Alvelestat has been evaluated in completed trials including NCT03679598, a Phase 2 study in alpha 1-antitrypsin deficiency, NCT03636347, a 12-week Phase 2 study in alpha1-antitrypsin-related COPD conducted across the United States and Europe, and NCT04539795, a Phase 1 COVID-19 safety and tolerability study in the United States.
Yes, Alvelestat is also known as MPH966, and trial listings refer to it as Alvelestat (MPH966). Other names used for the asset include Alvelestat oral tablet - dose 1 and Alvelestat - dose 1. All of these refer to the same oral small molecule developed by Mereo BioPharma.