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Also known as STAR-0215 (SC)
STAR-0215 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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 |
|---|---|---|
| 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: * Open to participants from STAR-0215-201 (NCT05695248) who have met one of the following conditions: * Completed STAR-0215-201 (follow up through 6 months after their last dose); * Eligible for STAR-0215-201 and entered the Run-In period but did not qualify for the Treatme...
| 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 |
STAR-0215 is an investigational small molecule being developed for the treatment of hereditary angioedema, a rare genetic condition characterized by recurrent episodes of severe swelling. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
STAR-0215 targets plasma kallikrein, a protein involved in the inflammatory pathway that leads to swelling in hereditary angioedema. By inhibiting this target, the drug aims to reduce the frequency and severity of angioedema attacks.
STAR-0215 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.
STAR-0215 is currently in Phase 2 clinical development. It has completed a Phase 1 trial in healthy volunteers and is now being studied in a long-term Phase 2 trial in patients with hereditary angioedema. The drug remains investigational and is not yet approved.
STAR-0215 has been studied in two clinical trials. NCT05477160 was a completed Phase 1 study in 41 healthy adult participants in the United States. NCT06007677 is an active Phase 2 long-term study in 56 participants with hereditary angioedema across multiple countries, including the United States, Bulgaria, Canada, Czechia, Germany, Poland, and the United Kingdom.