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Also known as STAR-0215
navenibart · 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 |
| ADARx Pharmaceuticals, Inc. | ADRX | 3 | PHASE3 | ADX-324 |
| Pharvaris N.V. | PHVS | 1 | PHASE2 | Deucrictibant |
| BioMarin Pharmaceutical Inc. | BMRN | 1 | PHASE1 | BMN 331 |
| Astria Therapeutics, Inc. | ATXS | 1 | PHASE2 | STAR-0215 |
Navenibart is an investigational therapy being developed for hereditary angioedema (HAE), a condition characterized by recurrent swelling attacks. It is in Phase 3 clinical development and is being studied in both adult and adolescent participants aged 12 years and older. Astria Therapeutics, Inc. (ATXS) is the developer.
Navenibart is being studied for the treatment of hereditary angioedema (HAE), a disorder involving recurrent episodes of swelling. Clinical trials are enrolling participants with HAE who are 12 years of age and older. It has not been approved for any indication and remains investigational.
Navenibart is being developed by Astria Therapeutics, Inc., which trades on the Nasdaq under the ticker ATXS. The company is running a Phase 3 program for the drug in hereditary angioedema, including a long-term extension study and a placebo-controlled trial.
Navenibart is in Phase 3 clinical development for hereditary angioedema. Two Phase 3 trials are ongoing, one actively enrolling by invitation and one active but not recruiting, following a completed Phase 1 study. It is investigational and has not received FDA approval.
Navenibart has been studied in three clinical trials. The Phase 3 trials are NCT07204938, a long-term study enrolling 145 participants, and NCT06842823, a placebo-controlled study with 157 participants. The completed Phase 1 trial is NCT05695248, which enrolled 29 participants.
Yes, navenibart is also known as STAR-0215. The completed Phase 1 trial is listed under the name STAR-0215, while the Phase 3 trials use the name navenibart. Both names refer to the same investigational compound being developed by Astria Therapeutics for hereditary angioedema.