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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, Normal Saline Administration |
| 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 | Dose 1 of BMN 331 |
| Astria Therapeutics, Inc. | ATXS | 1 | PHASE2 | STAR-0215 |
Navenibart is an investigational small molecule being developed for the treatment of Hereditary Angioedema (HAE), a rare genetic condition characterized by recurrent episodes of severe swelling. It is currently in clinical development and has not been approved by regulatory authorities.
Navenibart is being developed by Astria Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol ATXS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Hereditary Angioedema.
Navenibart is in Phase 3 clinical development for Hereditary Angioedema. One Phase 1 study has been completed, and two Phase 3 trials are currently active, including a long-term extension study. The drug remains investigational and is not yet approved.
Navenibart has been studied in three clinical trials. NCT05695248 was a completed Phase 1 study in 29 adults with Hereditary Angioedema. NCT06842823 is an active Phase 3 trial enrolling 157 participants aged 12 and older, and NCT07204938 is a long-term Phase 3 study enrolling 145 participants.
Yes, Navenibart is also known as STAR-0215. The Phase 1 clinical trial NCT05695248 was titled 'A Study of Navenibart (STAR-0215) in Participants With Hereditary Angioedema,' confirming that both names refer to the same investigational drug.