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Also known as Alvelestat oral tablet - dose 1, Alvelestat- dose 1, Alvelestat (MPH966), MPH966
Alvelestat · 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.
| 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 | placebo |
| 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 |
|---|---|---|
| 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 (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. |
| 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 that can lead to emphysema and COPD. It has also been studied in COVID-19. It is not yet approved and remains in clinical development.
Alvelestat targets ELANE, the gene encoding neutrophil elastase. It is an inhibitor of this enzyme. In alpha 1-antitrypsin deficiency, loss of elastase inhibition is central to lung tissue destruction, so blocking neutrophil elastase is the intended mechanism of the drug.
Alvelestat is being developed by Mereo BioPharma Group plc, which trades under the ticker MREO. The company holds the development program for the drug across its rare disease and COVID-19 indications.
Alvelestat is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The program has received FDA Orphan Drug and Fast Track designations, which are intended to support and expedite development of therapies for serious conditions.
Alvelestat has been studied in completed trials including NCT03679598, a Phase 2 study in alpha 1-antitrypsin deficiency, NCT03636347, a 12-week Phase 2 study in alpha 1-antitrypsin-related COPD, and NCT04539795, a Phase 1 COVID-19 safety and tolerability study. These trials enrolled 63, 99, and 15 participants respectively.
Yes. Alvelestat is also known as MPH966, and the two names refer to the same compound. It has additionally been catalogued as Alvelestat oral tablet dose 1 and Alvelestat dose 1. Searches for any of these names point to the same investigational drug developed by Mereo BioPharma.