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Also known as Brelovitug (BJT-778)
Brelovitug · 4 trials · 2 indications
The composite endpoint is defined as virologic response (HDV RNA ≥2 log10 IU/mL decrease from Baseline or undetectable HDV RNA (\< the lower limit of quantification \[LLOQ\], target not detected \[TND\]) and ALT normalization (decrease in ALT from baseline to ≤ upper limit of normal \[ULN\])
The composite endpoint is defined as virologic response (undetectable HDV RNA, \< the lower limit of quantification \[LLOQ\], target not detected \[TND\]) and ALT normalization (decrease in ALT from baseline to ≤ upper limit of normal \[ULN\])
The proportion of participants with undetectable HDV RNA (\<LLOQ, TND) at Week 24
Achieving composite endpoint defined as virologic response (undetectable HDV RNA or decline in HDV RNA ≥2 log10 IU/mL) and ALT normalization
| Arm | Type | Description |
|---|---|---|
| Brelovitug 300 mg | EXPERIMENTAL | Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks |
| Brelovitug 900 mg | EXPERIMENTAL | Participants will receive treatment with brelovitug 900 mg once every 4 weeks with a loading dose at Week 2 for 96 weeks |
| Delayed treatment with brelovitug 300 mg | ACTIVE_COMPARATOR | Participants will have 12 weeks of delayed treatment followed by brelovitug 300 mg once weekly for 96 weeks |
| Brelovitug | EXPERIMENTAL | Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks |
| Bulevirtide for 48 weeks followed by brelovitug for 48 weeks | ACTIVE_COMPARATOR | Participants will receive bulevirtide 2 mg subcutaneously once daily for 48 weeks, followed by brelovitug 300 mg subcutaneously once weekly for the next 48 weeks. |
| Immediate Switch to Brelovitug | EXPERIMENTAL | Participants will switch to brelovitug 300 mg once weekly for 96 weeks. |
| Delayed Switch from Bulevirtide to Brelovitug | EXPERIMENTAL | Participants will continue bulevirtide once daily and then switch to brelovitug 300 mg once weekly for 72 weeks. |
| Brelovitug 300mg | EXPERIMENTAL | Dose - brelovitug 300 mg Frequency- once weekly |
| Brelovitug 900mg | EXPERIMENTAL | Dose - brelovitug 900 mg Frequency- once every 4 weeks |
| Delayed Treatment with brelovitug 300mg | ACTIVE_COMPARATOR | Dose - brelovitug 300 mg Frequency- 24 weeks of delayed treatment, then once weekly |
| Name | Type | Description |
|---|---|---|
| Brelovitug 300 mg | DRUG | Route of administration- Subcutaneous Injection |
| Brelovitug 900 mg | DRUG | Route of administration- Subcutaneous Injection |
| Delayed Treatment with Brelovitug 300mg | DRUG | Route of administration- Subcutaneous Injection |
| Bulevirtide 2 mg and Brelovitug - 300 mg | DRUG | Route of Administration- Subcutaneous Injection |
| Brelovitug (BJT-778) | DRUG | Brelovitug (BJT-778), 300 mg administered subcutaneously once weekly for 96 weeks. |
| Bulevirtide | DRUG | Bulevirtide - once daily. Brelovitug (BJT-778) - 300 mg once weekly for 72 weeks following bulevirtide. |
Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Chronic HDV infection 3. HDV RNA \>500 IU/mL at Screening 4. ALT \>ULN at Screening 5. Willing to take or already taking HBV nucleos(t)ide therapy. Exclusion Criteria: 1. Pregnant or nursing females 2. Unwilling to com...
Brelovitug is an investigational therapy being developed for the treatment of chronic hepatitis D, also called chronic hepatitis delta infection. It is being studied in adults 18 years and older. The clinical program includes trials evaluating brelovitug both as a switch option for patients receiving bulevirtide and versus delayed treatment.
Brelovitug targets hepatitis B surface antigen, or HBsAg. It is a small molecule designed to act on HBsAg, the surface antigen of the hepatitis B virus that hepatitis D virus depends on to assemble and release infectious particles. Targeting HBsAg is the mechanism under investigation in chronic hepatitis D.
Brelovitug is being developed by Mirum Pharmaceuticals, Inc., which trades under the ticker MIRM. Mirum is running the clinical program for the drug in chronic hepatitis D, including the AZURE-2 and AZURE-4 trials and a Phase 2 study evaluating switching from bulevirtide to brelovitug.
Brelovitug is in clinical development and has not been approved. The program includes Phase 2 and Phase 3 studies in chronic hepatitis D. Two Phase 3 trials, AZURE-2 and AZURE-4, are evaluating brelovitug, and Phase 2 studies are also ongoing or active but not recruiting.
Brelovitug is being studied in three active trials. NCT07200908 (AZURE-2) is a recruiting Phase 3 trial comparing brelovitug with bulevirtide. NCT07298330 (AZURE-4) is an active Phase 3 trial versus delayed treatment. NCT07454837 is a recruiting Phase 2 trial of switching to brelovitug in patients receiving bulevirtide.
Yes, BJT-778 is another name for brelovitug. The compound also appears in study listings as brelovitug 300 mg and as delayed treatment with brelovitug 300 mg, which refers to the delayed treatment arm of the clinical trials. All of these names refer to the same investigational small molecule developed by Mirum Pharmaceuticals.