Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MEDI528
MEDI-528/kg · 4 trials · 1 indication
Change at Day 92 from baseline (Day 1, prior to dosing) in mean ACQ scores in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Number of participants with troponin levels greater than upper limit of normal
Number of participants with abnormal clinically significant ECG results
Number of participants experiencing abnormal clinically significant MRI results
Number of participants experiencing serious adverse events
Change from baseline (percent reduction) in mean maximum decline of forced expiratory volume in one second (FEV1) during LAR at 3 to 7 hours after an inhaled allergen challenge.
Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Change from baseline (percent reduction) in mean maximum decline of FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
Change from baseline (percent reduction) in mean maximum decline of area under the concentration-time curve (AUC) of the participants FEV1 during LAR at 3 to 7 hours after an inhaled allergen challenge.
| Arm | Type | Description |
|---|---|---|
| MEDI528 30 mg | EXPERIMENTAL | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| MEDI528 100 mg | EXPERIMENTAL | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| MEDI528 300 mg | EXPERIMENTAL | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Placebo | EXPERIMENTAL | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks |
| MEDI528 0.3 mg/kg | EXPERIMENTAL | MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks |
| MEDI528 1 mg/kg | EXPERIMENTAL | MEDI-528 at a dose of 1 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks |
| MEDI528 3 mg/kg | EXPERIMENTAL | MEDI-528 at a dose of 3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks |
| MEDI528 9 mg/kg | EXPERIMENTAL | MEDI-528 at a single dose of 9 mg/kg administered as an intravenous infusion |
| MEDI-528 0.3 mg/kg | EXPERIMENTAL | MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose |
| MEDI-528 1 mg/kg | EXPERIMENTAL | MEDI-528 (1 mg/kg) administered as a single, IV dose |
| MEDI-528 3 mg/kg | EXPERIMENTAL | MEDI-528 (3 mg/kg) administered as a single, IV dose |
| MEDI-528 9 mg/kg | EXPERIMENTAL | MEDI-528 (9 mg/kg) administered as a single, IV dose |
| Name | Type | Description |
|---|---|---|
| MEDI528 30 mg | BIOLOGICAL | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| MEDI528 100 mg | BIOLOGICAL | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| MEDI528 300 mg | BIOLOGICAL | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Placebo | OTHER | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks |
| MEDI528 0.3 mg/kg | BIOLOGICAL | MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks |
| MEDI528 1 mg/kg | BIOLOGICAL | MEDI-528 at a dose of 1 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks |
| MEDI528 3 mg/kg | BIOLOGICAL | MEDI-528 at a dose of 3 mg/kg administered twice weekly as a subcutaneous (SC) dose for 4 weeks |
| MEDI-528 9 mg/kg | BIOLOGICAL | MEDI-528 at a single dose of 9 mg/kg administered as an intravenous infusion |
| MEDI-528 0.3 mg/kg | BIOLOGICAL | MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose |
| MEDI-528 1 mg/kg | BIOLOGICAL | MEDI-528 (1 mg/kg) administered as a single, IV dose |
| MEDI-528 3 mg/kg | BIOLOGICAL | MEDI-528 (3 mg/kg) administered as a single, IV dose |
Inclusion Criteria Subjects must meet all of the following criteria: 1. Male or female 2. Age 18 through 65 years at the time of screening 3. Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including scr...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
MEDI-528/kg is an investigational monoclonal antibody that was studied for the treatment of asthma. It was evaluated in adults with asthma, including mild persistent asthma and atopic asthma, across Phase 1 and Phase 2 clinical trials. It is not an approved therapy.
MEDI-528/kg was developed by AstraZeneca PLC, which trades on the NASDAQ under the ticker AZN. The company sponsored the clinical trial program evaluating the antibody in asthma, including studies conducted in North America, South America, Asia, and Europe.
MEDI-528/kg reached Phase 2 clinical development for asthma. Four trials have been completed, including three Phase 2 studies and one Phase 1 study, and no trials are currently active. It is an investigational agent and has not been approved for any indication.
MEDI-528/kg has been evaluated in four completed trials: NCT00968669, a 329-patient Phase 2 study in adults with asthma; NCT00507130, a 36-patient Phase 2 study in mild persistent asthma; NCT00394654, a 30-patient Phase 2 study of late asthmatic response; and NCT00192296, a 24-patient Phase 1 study in healthy volunteers.
The MEDI-528/kg clinical program enrolled a total of 419 patients across four completed trials. The largest study, NCT00968669, enrolled 329 adults with asthma. All four trials were randomized, double-blind, and controlled, and none included biomarker-selected populations.