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Also known as STAR-0215 (SC), navenibart
STAR-0215 · 5 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Adult Dosing Regimen 1 | EXPERIMENTAL | Participants will receive 600 mg of navenibart every 3 months. |
| Adult Dosing Regimen 2 | EXPERIMENTAL | Participants will receive 300 mg of navenibart every 3 months. |
| Adult Dosing Regimen 3 | EXPERIMENTAL | Participants will receive 600 mg of navenibart every 6 months. |
| Adolescent Dosing Regimen 1 | EXPERIMENTAL | Participants will receive 300 mg of navenibart every 3 months. |
| Adult Navenibart Dosing Regimen 1 | EXPERIMENTAL | Participants will receive 600 mg of navenibart every 3 months. |
| Adult Navenibart Dosing Regimen 2 | EXPERIMENTAL | Participants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3. |
| Adult Navenibart Dosing Regimen 3 | EXPERIMENTAL | Participants will receive 600 mg of navenibart every 6 months. |
| Placebo (adult) | PLACEBO_COMPARATOR | Participants will receive placebo every 3 months. |
| Adolescent Navenibart Dosing Regimen 1 | EXPERIMENTAL | Participants will receive 600 mg of navenibart on Day 1 and 300 mg every 3 months starting at month 3. |
| Dose Regimen 1 (Arm A): STAR-0215 | EXPERIMENTAL | Participants will receive STAR-0215 every 3 months. |
| Dose Regimen 2 (Arm B): STAR-0215 | EXPERIMENTAL | Participants will receive STAR-0215 every 6 months. |
| Dose Regimen 1 (Arm C): STAR-0215 | EXPERIMENTAL | STAR-0215 will be administered as a subcutaneous injection. |
| Dose Regimen 3 (Arm D): STAR-0215 | EXPERIMENTAL | STAR-0215 will be administered as a subcutaneous injection. |
| Cohort 1 - Single Dose | EXPERIMENTAL | Participants received 1 dose (450 milligrams \[mg\]) of navenibart. |
| Cohort 2 - Multiple Dose | EXPERIMENTAL | Participants received 2 doses (600 mg, 300 mg) of navenibart administered 3 months apart. |
| Cohort 3 - Multiple Dose | EXPERIMENTAL | Participants received 2 doses (600 mg) of navenibart administered 1 month apart. |
| STAR-0215 Dose 1 | EXPERIMENTAL | Participants will be randomized to receive STAR-0215 or placebo. |
| STAR-0215 Dose 2 | EXPERIMENTAL | Participants will be randomized to receive STAR-0215 or placebo. |
| STAR-0215 Dose 3 | EXPERIMENTAL | Participants will be randomized to receive STAR-0215 or placebo. |
| STAR-0215 Dose 4 | EXPERIMENTAL | Participants will be randomized to receive STAR-0215 or placebo. |
| STAR-0215 Dose 5 | EXPERIMENTAL | Participants will be randomized to receive STAR-0215 or placebo. |
| Name | Type | Description |
|---|---|---|
| navenibart | DRUG | Navenibart will be administered as a subcutaneous injection. |
| Placebo | DRUG | Placebo will be administered as a subcutaneous injection. |
| STAR-0215 | DRUG | STAR-0215 will be administered as a subcutaneous injection. |
| STAR-0215 (SC) | DRUG | STAR-0215 will be administered as an SC bolus injection. |
| Placebo (SC) | DRUG | Placebo will be administered as an SC bolus injection. |
| STAR-0215 (IV) | DRUG | STAR-0215 will be administered as an IV bolus injection. |
| Placebo (IV) | DRUG | Placebo will be administered as an IV bolus injection. |
Inclusion Criteria: 1\. Participants from STAR-0215-301 who met one of the following conditions: 1. Completed STAR-0215-301 through the Day 181 visit 2. Withdrew from STAR-0215-301 but met the following criteria: i. Received 2 doses of IP ii. completed ≥ 2 months of trial follow-up after the seco...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Intellia Therapeutics, Inc. | NTLA | 3 | PHASE3 | NTLA-2002 |
| BioCryst Pharmaceuticals, Inc. | BCRX | 2 | PHASE3 | Berotralstat |
| Ionis Pharmaceuticals, Inc. | IONS | 1 | PHASE3 | Donidalorsen |
| Pharvaris N.V. | PHVS | 1 | PHASE2 | Deucrictibant |
| BioMarin Pharmaceutical Inc. | BMRN | 1 | PHASE1 | BMN 331 |
| Astria Therapeutics, Inc. | ATXS | 1 | PHASE2 | STAR-0215 |
STAR-0215 is being developed for the treatment of hereditary angioedema, a rare condition characterized by recurrent swelling attacks. It is an investigational therapy and has not been approved for any indication. Clinical development is currently in Phase 2.
STAR-0215 targets plasma kallikrein, a protein involved in the kallikrein-kinin pathway that drives swelling attacks in hereditary angioedema. By binding to plasma kallikrein, the drug aims to reduce the generation of bradykinin, which is thought to contribute to the edema attacks seen in this condition.
STAR-0215 is being developed by Astria Therapeutics, Inc., which trades on the Nasdaq under the ticker ATXS. The company is responsible for the clinical program evaluating the drug in hereditary angioedema.
STAR-0215 is in Phase 2 clinical development. One Phase 2 trial is active and not recruiting, and one Phase 1 trial has been completed. The drug remains investigational and has not received regulatory approval.
STAR-0215 has been studied in two clinical trials. The Phase 2 long-term study, NCT06007677, is active but not recruiting and has enrolled 56 participants with hereditary angioedema across the United States, Bulgaria, Canada, Czechia, Germany, Poland, and the United Kingdom. The completed Phase 1 trial, NCT05477160, enrolled 41 healthy adult participants in the United States.
Yes, STAR-0215 (SC) is another name for STAR-0215. The SC designation refers to the subcutaneous route of administration. Both names refer to the same investigational drug being developed by Astria Therapeutics for hereditary angioedema.