Drugs / Alvelestat
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT01214122 | Nov → Dec 2010 | — | AstraZeneca | Withdrawn | No outcome recorded |
| Phase 1 | NCT01161355 | Jun 2010 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01147549 | Jun → Jul 2010 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01035411 | Nov → Dec 2009 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01034982 | Nov → Dec 2009 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03986086 | Sep 2021 → Dec 2022 | hematopoietic and lymphoid cell neoplasm | Nelson Chao | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT02669251 | Apr 2016 → Dec 2027 expected | bronchiolitis obliterans syndrome, chronic graft versus host disease | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 26 trials · 1 missed | ||||||
| Phase 2 | NCT02597101 | Nov 2015 → Jun 2019 | type 2 diabetes mellitus | Nick Giannoukakis, PhD | Completed | Missed primary |
| Phase 2 | NCT01054170 | Jan → Nov 2010 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT01023516 | Nov 2009 → Aug 2010 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00757848 | Oct 2008 → Aug 2009 | cystic fibrosis | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00769119 | Sep 2008 → Apr 2009 | bronchiectasis | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00703391 | Jun → Sep 2008 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 1/2 | NCT04539795 Comparator | Jan → Oct 2021 | COVID-19 | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 2 | NCT03679598 Comparator | Apr 2019 → Nov 2023 | alpha 1-antitrypsin deficiency, chronic obstructive pulmonary disease | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 2 | NCT03636347 Comparator | Oct 2018 → Mar 2022 | alpha 1-antitrypsin deficiency, pulmonary emphysema | Mereo BioPharma | Completed | No outcome recorded |
| Phase 2 | NCT00949975 Comparator | Jul 2009 → Aug 2010 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2025-01-12 | Mereo BioPharma | Regulatory Mereo BioPharma Provides Update on Lead Clinical Programs mereobiopharma.com ↗
Alvelestat, for Alpha-1 Antitrypsin Deficiency-associated Lung Disease, receives positive EMA opinion on European Orphan Designation Application; European Commission expected to issue final decision in first quarter 2025 |
| 2023-05-23 | Mereo BioPharma | Results Phase 2 Data from “ASTRAEUS” Trial of Mereo BioPharma’s Alvelestat in Alpha-1 Antitrypsin Deficiency-associated Lung Disease Presented at the 2023 American Thoracic Society International Conference mereobiopharma.com ↗
Low - and high-dose alvelestat significantly suppressed NE activity compared to baseline (-83.5% and -93.3%, p=0.023 and p<0.001 respectively) and versus placebo (p=0.001 and p<0.001). |
| 2023-03-21 | Mereo BioPharma | Regulatory Mereo BioPharma Provides Regulatory Updates on Alvelestat for the Treatment of Alpha-1-Antitrypsin Deficiency-Associated Lung Disease mereobiopharma.com ↗ |
| 2023-03-21 | Mereo BioPharma | Regulatory Mereo BioPharma Provides Regulatory Updates on Alvelestat for the Treatment of Alpha-1-Antitrypsin Deficiency-Associated Lung Disease mereobiopharma.com ↗ |
| 2022-10-17 | Mereo BioPharma | Regulatory Mereo BioPharma Receives FDA Fast Track Designation for Alvelestat for Treatment of Alpha-1 Antitrypsin Deficiency (AATD)-associated Lung Disease mereobiopharma.com ↗
We are grateful to the FDA for granting us Fast Track designation, and for their recognition of alvelestat as a potentially first-in-class oral neutrophil elastase inhibitor. |
| 2022-05-09 | Mereo BioPharma | Results Mereo BioPharma announces Positive Top-Line Efficacy and Safety Data from “ASTRAEUS” Phase 2 Trial of Alvelestat in Alpha-1 Antitrypsin Deficiency- associated Emphysema mereobiopharma.com ↗
At the high dose, alvelestat demonstrated statistically significant changes versus placebo in all three primary biomarker endpoints. |
| 2021-12-22 | Mereo BioPharma | Results UAB and Mereo Announce Positive Top-line Results from “COSTA” a Phase 1b/2 Trial of Alvelestat (MPH966) in Hospitalized Patients with COVID-19 Respiratory Disease mereobiopharma.com ↗
In the alvelestat arm 62.5% (5/8) patients had a 2-point decrease in the WHO Disease Severity score by Day 5, compared to 28.5% (2/7) patients in the placebo arm. |
| 2021-12-13 | Mereo BioPharma | Results Biomarker Data from Phase 1b/2 Investigator-sponsored Trial of Mereo’s Alvelestat in Bronchiolitis Obliterans Syndrome (BOS) at the ASH Annual Meeting mereobiopharma.com ↗
Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the “Company”), a clinical stage biopharmaceutical company focused on oncology and rare diseases, today announced the presentation of data from the initial seven patients in an investigator-sponsored study of alvelestat in patients with BOS following hematopoietic stem cell transplantation (“HCT”). |
| 2021-11-04 | Mereo BioPharma | Results Data from Investigator-sponsored Trial of Mereo BioPharma’s alvelestat in Bronchiolitis Obliterans Syndrome (BOS) Accepted for Presentation at American Society of Hematology (ASH) Annual Meeting mereobiopharma.com ↗
There was consistency of a suppressive effect on biomarkers of elastase activity and collagen turnover in 6 of 7 treated patients, all of whom had improved or stable lung disease. |
| 2021-10-26 | Mereo BioPharma | Regulatory Mereo BioPharma Receives U.S. Orphan Drug Designation for alvelestat in the Treatment of alpha-1 antitrypsin deficiency mereobiopharma.com ↗
the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to alvelestat for the treatment of alpha-1 antitrypsin deficiency (AATD). |
| 2021-06-02 | Mereo BioPharma | Results Mereo BioPharma Announces Positive Desmosine Biomarker Data from an Interim Analysis of an Investigator Initiated Study of alvelestat in Bronchiolitis Obliterans Syndrome (BOS) mereobiopharma.com ↗
Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the “Company”), a clinical stage biopharmaceutical company focused on oncology and rare diseases, today announced positive data from an interim analysis of an investigator-initiated study of alvelestat in patients with Bronchiolitis Obliterans Syndrome (“BOS”) following hematopoietic stem cell transplantation (“HCT”). |
All press releases naming this drug 14 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Alvelestat | “Alvelestat (MPH966) (Formerly known as AZD9668) is a potent and selective inhibitor of NE” NCT02669251 ↗ |
| Known as | AZD9668 | “Alvelestat (MPH966, formerly AZD9668) is a potent, selective, and reversible, oral inhibitor of human NE.” NCT03679598 ↗13“Alvelestat (MPH966) (Formerly known as AZD9668) is a potent and selective inhibitor of NE” NCT02669251 ↗ |
| Known as | MPH966 | “Alvelestat (MPH966, formerly AZD9668) is a potent, selective, and reversible, oral inhibitor of human NE.” NCT03679598 ↗2“Alvelestat (MPH966) (Formerly known as AZD9668) is a potent and selective inhibitor of NE” NCT02669251 ↗ |
| Action | Inhibit | “neutrophil elastase inhibitor AZD9668” PMID 22267768 ↗ Jan 20121“Leukocyte elastase inhibitor” CHEMBL3617964 ↗ |
| Modality | Small molecule | — CHEMBL3617964 ↗ |
| Route | Oral | “30mg oral tablets twice daily (bid) for 14 days” NCT00703391 ↗ |
| Target | ELANE | “Leukocyte elastase inhibitor” CHEMBL3617964 ↗ |