Approval Probability
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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 small molecule being developed for the treatment of chronic hepatitis D, also known as chronic hepatitis D infection. It is currently in clinical development and has not been approved by regulatory authorities.
Brelovitug is being developed by Mirum Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol MIRM. The drug is also known as BJT-778 and is being studied in multiple clinical trials for chronic hepatitis D.
Brelovitug is in Phase 2 and Phase 3 clinical trials for chronic hepatitis D infection. It is an investigational drug, meaning it has not yet received regulatory approval and is still being evaluated for safety and efficacy in clinical studies.
Brelovitug is being studied in several trials, including NCT06907290 (Phase 2, comparing BJT-778 to delayed treatment), NCT07200908 (Phase 3, AZURE-2, comparing Brelovitug to bulevirtide), NCT07298330 (Phase 3, AZURE-4, comparing Brelovitug to delayed treatment), and NCT07454837 (Phase 2, evaluating switching to Brelovitug in patients receiving bulevirtide).
Yes, Brelovitug is also known as BJT-778. Clinical trial records refer to the drug as both Brelovitug and BJT-778, and it is being evaluated for the treatment of chronic hepatitis D infection.
AZURE-2 is a Phase 3 clinical trial (NCT07200908) comparing Brelovitug (BJT-778) to bulevirtide for the treatment of chronic hepatitis D infection. The trial is recruiting participants in multiple European countries and Uzbekistan.