Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as FP, SAL
MGR001 · 3 trials · 2 indications
The FEV1 AUEC(0-12) on Day 1 was calculated from FEV1 measurements collected 30 minutes prior to morning dose, 0 minutes prior to morning dose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours following completion of dosing on Day 1 (Visit 3). The baseline for the FEV1 AUEC(0-12) endpoint was the mean of the 2 predose FEV1 measures. To confirm assay sensitivity, both active treatments (MGR001 and Advair Diskus) had to be significantly superior to placebo
The FEV1 AUEC(0-12) on Day 1 was calculated from FEV1 measurements collected 30 minutes prior to morning dose, 0 minutes prior to morning dose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours following completion of dosing on Day 1 (Visit 3). The baseline for the FEV1 AUEC(0-12) endpoint was the mean of the 2 predose FEV1 measures
Change from baseline in trough (pre-dose) FEV1 at Day 29 was based on 2 pre-dose FEV1 assessments performed 30 minutes apart on Day 29. Baseline was calculated by taking the mean of \[prebronchodilator FEV1 measured at a run-in visit and the mean of 2 predose FEV1 measures taken at Day 1\]. To confirm assay sensitivity, both active treatments (MGR001 and Advair Diskus) had to be significantly superior to placebo.
Change from baseline in trough (pre-dose) FEV1 at Day 29 was based on 2 pre-dose FEV1 assessments performed 30 minutes apart on Day 29. Baseline was calculated by taking the mean of \[prebronchodilator FEV1 measured at a run-in visit and the mean of 2 predose FEV1 measures taken at Day 1\]
CRC749 inhaler robustness will be assessed by in vitro testing of the CRC749 inhaler after 3 weeks of patient use of the MGR001 product.
| Arm | Type | Description |
|---|---|---|
| MGR001 | EXPERIMENTAL | MGR001 administered two times per day by inhalation throughout the study |
| Advair Diskus | ACTIVE_COMPARATOR | Advair Diskus administered two times per day by inhalation throughout the study |
| Placebo | PLACEBO_COMPARATOR | Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study |
| Advair® Diskus® | EXPERIMENTAL | FP/SAL 250/50 µg 3 x inhalations (total dose 750/150 µg) administered via Diskus® inhaler. |
| Seretide™ Accuhaler™ | EXPERIMENTAL | FP/SAL 250/50 µg 3 x inhalations (total dose 750/150 µg) administered via Accuhaler™ inhaler. |
| Name | Type | Description |
|---|---|---|
| MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate) | DRUG | Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device |
| Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate) | DRUG | Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device |
| Placebo | DRUG | Placebo administered via the CRC749 and Diskus devices |
| MGR001 | DRUG | Fluticasone Propionate / Salmeterol administered using CRC749 inhaler |
| CRC749 inhaler | DEVICE | - |
| Advair® Diskus® | DRUG | Fluticasone Propionate is an inhaled corticosteroid (ICS) Salmeterol is a long acting β2 agonist (LABA) |
| Seretide™ Accuhaler™ | DRUG | Fluticasone Propionate is an inhaled corticosteroid (ICS) Salmeterol is a long acting β2 agonist (LABA) |
Key inclusion criteria include: * Male or female subjects aged ≥18 years. Females may be of either childbearing or non-childbearing potential * Physician diagnosed history of asthma for at least 12 weeks prior to screening * pre-bronchodilator FEV1 60-85% at screening and other specified visits * P...
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 |
MGR001 is being developed for the treatment of asthma. It is a fixed dose combination product containing fluticasone propionate and salmeterol xinafoate, delivered by inhalation. The clinical program has focused on demonstrating local equivalence and systemic exposure relative to an existing dry powder inhaler in patients with asthma.
MGR001 is being developed by Viatris Inc., which trades on the Nasdaq under the ticker VTRS. Viatris is the sponsor of the clinical program, which includes completed Phase 1 and Phase 3 studies in asthma and COPD conducted in the United States and the United Kingdom.
MGR001 has completed Phase 3 clinical development. Three trials are listed as completed, including a Phase 3 local equivalence study in asthma with 1,128 participants. No trials are currently active. MGR001 is an investigational product and has not been approved by the FDA.
MGR001 has been studied in three completed trials. NCT02245672 was a Phase 3 local equivalence study versus Advair Diskus in asthma with 1,128 participants. NCT02474017 was a Phase 1 inhaler robustness study with 111 participants, and NCT02215122 was a Phase 1 bioequivalence study with 40 healthy volunteers.