Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 317 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| AMG 317 75 mg | EXPERIMENTAL | 75 subjects |
| Placebo Arm | PLACEBO_COMPARATOR | 75 subjects |
| AMG 317 300 mg | EXPERIMENTAL | 75 subjects |
| AMG 317 150 mg | EXPERIMENTAL | 75 subjects |
| Name | Type | Description |
|---|---|---|
| AMG 317 75 mg | BIOLOGICAL | 75 mg SC weekly injection |
| AMG 317 150 mg | BIOLOGICAL | 150 mg SC once weekly injection |
| AMG 317 300 mg | BIOLOGICAL | 300 mg weekly SC injection |
| Placebo | BIOLOGICAL | Placebo SC once weekly injection |
Inclusion Criteria: * Males or females 18 to 65 years of age at the time of screening * Baseline percent of predicted FEV1 ≥ 50% to ≤ 80% at screening * At least 12% reversibility over baseline FEV1 with beta agonist inhalation, which can be demonstrated in the office or documented by medical recor...
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 |
AMG 317 is an investigational monoclonal antibody that was studied for the treatment of asthma. It was evaluated in adults 18 years and older with asthma in a Phase 2 clinical trial. It is not an approved therapy and is no longer in active clinical development.
AMG 317 was developed by Amgen Inc., which trades on the Nasdaq under the ticker AMGN. Amgen sponsored the Phase 2 asthma study of the antibody. No other developer or partner is associated with the program based on the available record.
AMG 317 reached Phase 2 clinical development for asthma. The single Phase 2 trial has been completed, and no trials are currently active. The drug remains investigational and has not been approved by the FDA for any indication.
AMG 317 was studied in one completed Phase 2 trial, NCT00436670, titled a Phase II Study to Evaluate the Efficacy of AMG 317. The trial enrolled 294 adults with asthma, was randomized, double-blind, and placebo-controlled. No active trials of AMG 317 are ongoing.
The Phase 2 trial NCT00436670 was a randomized, double-blind, placebo-controlled study of AMG 317 in asthma. It enrolled 294 participants aged 18 years and older of all sexes, and it did not enroll healthy volunteers. The study has been completed.