Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Efavaleukin Alfa · 2 trials · 2 indications
Blood samples were collected to determine PK parameters.
Blood samples were collected to determine PK parameters.
Blood samples were collected to determine PK parameters.
Blood samples were collected to determine PK parameters.
A TEAE was defined as any adverse event (AE) starting on or after the first dose of investigational product through to the safety follow-up visit. Any clinically significant changes in physical examinations, vital signs, and clinical laboratory test results were recorded as AEs.
| Arm | Type | Description |
|---|---|---|
| Group 1: Chinese participants - efavaleukin alfa dose level 1 | EXPERIMENTAL | Chinese participants will receive a single dose of efavaleukin alfa at dose level 1. |
| Group 2: Chinese participants - efavaleukin alfa dose level 2 | EXPERIMENTAL | Chinese participants will receive a single dose of efavaleukin alfa at dose level 2. |
| Group 3: Japanese participants - efavaleukin alfa dose level 2 | EXPERIMENTAL | Japanese participants will receive a single dose of efavaleukin alfa at dose level 2. |
| Group 4: Caucasian participants - efavaleukin alfa dose level 2 | EXPERIMENTAL | Caucasian participants will receive a single dose of efavaleukin alfa at dose level 2. |
| Efavaleukin Alfa | EXPERIMENTAL | Approximately 29 participants will be randomized in a 5:2 ratio (cohorts 1, 2, and 3) or in a 3:1 ratio (cohorts 4 and 5) to Efavaleukin Alfa or placebo in addition to standard of care therapy. Efavaleukin Alfa or placebo will be administered either weekly (QW) or biweekly (Q2W). |
| Placebo | PLACEBO_COMPARATOR | Approximately 29 participants will be randomized in a 5:2 ratio (cohorts 1, 2, and 3) or in a 3:1 ratio (cohorts 4 and 5) to Efavaleukin Alfa or placebo in addition to standard of care therapy. Efavaleukin Alfa or placebo will be administered either weekly (QW) or biweekly (Q2W). |
| Name | Type | Description |
|---|---|---|
| Efavaleukin alfa | DRUG | Administered as a single dose SC injection. |
| Placebo | DRUG | The placebo will be administered by subcutaneous (SC) injection in the abdomen, thigh or upper arm. |
Inclusion Criteria: * Healthy male or female participants, between 18 and 55 years of age (inclusive) at the time of Screening. * Chinese, Japanese, or Caucasian participant: * Chinese participants must be of Chinese ancestry (4 grandparents and biological parents). * Japanese participants mus...
Top 20 of 32 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Biogen Inc. | BIIB | 5 | PHASE3 | Litifilimab |
| Bristol-Myers Squibb Company | BMY | 7 | PHASE3 | Deucravacitinib |
| Viatris, Inc. | VTRS | 5 | PHASE3 | Cenerimod |
| Novartis AG Sponsored ADR | NVS | 7 | PHASE3 | Ianalumab |
| AstraZeneca PLC | AZN | 21 | PHASE3 | Medi-546 |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Nipocalimab |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Upadacitinib |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Belimumab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE2 | SAR441344 |
| Zenas BioPharma, Inc. | ZBIO | 1 | PHASE2 | Obexelimab |
| Alumis Inc. | ALMS | 1 | PHASE2 | Envudeucitinib |
| Immunovant Inc | IMVT | 1 | PHASE2 | IMVT-1402 |
| Amgen Inc. | AMGN | 1 | PHASE2 | Inebilizumab, Blinatumomab |
| Fate Therapeutics, Inc. | FATE | 2 | PHASE2 | FT819 |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY4298445 |
| Cartesian Therapeutics, Inc. | RNAC | 2 | PHASE2 | Descartes-08 |
| Merck & Co., Inc. | MRK | 1 | PHASE1 | MK-1045 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE1 | KITE-363, Fludarabine, Cyclophosphamide |
| Artiva Biotherapeutics, Inc. | ARTV | 2 | PHASE1 | AB-101, Cyclophosphamide, Fludarabine, Rituximab, Obinutuzumab |
| Cullinan Therapeutics, Inc. | CGEM | 1 | PHASE1 | CLN-978 |
Efavaleukin Alfa is an investigational drug being studied for inflammatory diseases and systemic lupus erythematosus. It is in Phase 1 clinical development and is not approved by the FDA. The drug is being developed by Amgen Inc. (AMGN) as a potential treatment for these conditions.
Efavaleukin Alfa is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is currently in Phase 1 clinical trials for inflammatory diseases and systemic lupus erythematosus.
Efavaleukin Alfa is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials have been completed for systemic lupus erythematosus and for healthy participants with inflammatory diseases.
Efavaleukin Alfa has completed two Phase 1 trials. NCT03451422 studied the drug in 35 participants with systemic lupus erythematosus in the US, France, Germany, and Poland. NCT04987333 studied it in 32 healthy Chinese, Japanese, and Caucasian participants in the UK for inflammatory diseases.
Efavaleukin Alfa is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for inflammatory diseases and systemic lupus erythematosus. The drug has completed early-stage trials but remains under investigation.