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navenibart · 3 trials · 2 indications
An adverse event was any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product that did not necessarily have a causal relationship with the treatment. A treatment-emergent adverse event was defined as any adverse event with an onset at the time of or following the start of treatment with study drug, or medical conditions present before the start of treatment that increased in severity or relationship at the time of or following the start of treatment. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' section.
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| navenibart | DRUG | Navenibart will be administered as a subcutaneous injection. |
| Placebo | DRUG | Placebo will be administered as a subcutaneous 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 |
Navenibart is being developed for the treatment of hereditary angioedema (HAE), a condition characterized by recurrent swelling attacks. It is an investigational therapy and has not been approved by regulatory authorities. Clinical trials are evaluating its use in participants with HAE.
Navenibart is being developed by Astria Therapeutics, Inc., which trades on the Nasdaq under the ticker symbol ATXS. The company is responsible for the clinical development program of navenibart.
Navenibart is in Phase 3 clinical development. Two Phase 3 trials are ongoing: one is active but not recruiting, and the other is enrolling by invitation. A Phase 1 trial has been completed.
Navenibart is being studied in two Phase 3 trials: NCT06842823, which is active but not recruiting, and NCT07204938, which is enrolling by invitation. A completed Phase 1 trial is registered as NCT05695248. All trials are in participants with hereditary angioedema.
Yes, navenibart is also known as STAR-0215. The Phase 1 trial for navenibart is listed under the title 'A Study of Navenibart (STAR-0215) in Participants With Hereditary Angioedema,' confirming that the two names refer to the same investigational drug.