Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABI-6250 · 3 trials · 4 indications
Number of participants with at least one clinically significant laboratory parameters abnormality. The following parameters will be measured: Serum Chemistry: ALT, ALB, Alk phos, AST, BUN, Ca, Co2, Cl, Creatinine kinase, eGFR, GGT, Total Cholesterol, Trig, Glucose, LDH, Potassium, Sodium, T. Bili, D. Bili and I. Bili, Total protein. Hematology: HCT, HGB, MPV, Platelet count, RBC count, RBC indices (MCH, MCHC, MCV, RDW), WBC count, WBC differential (BASO, EOS, LYMPH, MONO, NEUT). Urinalysis: UCLA, UBILQL, UCOL, UGLUQ, UKET, UWEST, UNIT, UOCULT, pH, protein, Specific gravity. Coagulation: aPTT, PT, FIB, INR.
Number of participants with at least one clinically significant vitals abnormality. The following clinical signs will be measured: systolic blood pressure (mmHg), diastolic blood pressure (mmHg), heart rate (beats/min), respiratory rate (breaths/min), and body temperature (C°).
Number of participants with at least one clinically significant electrocardiogram abnormality. The following standard 12-lead ECG will be recorded: PR interval (msec), QRS duration (msec), QT interval (msec), QTCF interval (msec), heart rate (beats/min), RR (msec), and interpretation.
Number of participants with at least one clinically significant physical abnormality. A complete physical examination, including at a minimum, assessments of the general appearance, respiratory, cardiovascular, gastrointestinal, musculoskeletal, and dermatological systems, in addition to examinations of the head, eyes, ears, nose, throat, neck, and lymph nodes, as well as height and weight measurement to calculate BMI.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm 1 | EXPERIMENTAL | - |
| Treatment Arm 2 | EXPERIMENTAL | - |
| Treatment Arm 3 | EXPERIMENTAL | - |
| Treatment Arm 4 | EXPERIMENTAL | - |
| Cohort 1 & 2, ABI-6250 | EXPERIMENTAL | - |
| Part A: SAD Cohorts 1-5, ABI-6250 | EXPERIMENTAL | - |
| Part A: SAD Cohorts 1-5, Placebo | PLACEBO_COMPARATOR | - |
| Part A: SAD Food Effect Cohort 6 or 7: ABI-6250 | EXPERIMENTAL | - |
| Part A: SAD Food Effect Cohort 6 (if applicable): Placebo | PLACEBO_COMPARATOR | - |
| Part B: MAD Cohorts 1-4, ABI-6250 | EXPERIMENTAL | - |
| Part B: MAD Cohorts 1-4, Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ABI-6250 | DRUG | Once daily tablet dosing for 48 weeks starting at Day 1 visit |
| Placebo | DRUG | Single dose (SAD) or once or twice daily dosing over 10 days (MAD) |
Inclusion Criteria: * Participant has a body mass index ≥18.0 and \<35.0 kg/m2 at Screening * Other than HBV and HDV infection, the participant is in good health (as determined by the Investigator) based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and cli...
ABI-6250 is an investigational small molecule being developed for chronic hepatitis D virus infection, also known as hepatitis delta. Assembly Biosciences is also studying it in people with mild hepatic impairment. It has not been approved for any use and remains in clinical development.
ABI-6250 targets NTCP, the sodium taurocholate cotransporting polypeptide. NTCP is the liver cell entry receptor that hepatitis delta virus uses to infect hepatocytes, so blocking it is intended to interfere with viral entry into liver cells.
ABI-6250 is being developed by Assembly Biosciences, Inc., which trades on the Nasdaq under the ticker ASMB. The company is running the hepatitis delta clinical program as well as separate studies in healthy participants and in people with mild hepatic impairment.
ABI-6250 is in Phase 2 development for chronic hepatitis D virus infection. Supporting Phase 1 studies have evaluated safety, tolerability and pharmacokinetics in healthy participants and in participants with mild hepatic impairment. The drug is investigational and has not been approved by the FDA.
ABI-6250 has three registered studies. NCT07762027 is a Phase 2 trial in chronic hepatitis D infection across Europe, New Zealand and Pakistan. NCT07850999 is a Phase 1 study in mild hepatic impairment in New Zealand, and NCT06740474 is a completed Phase 1 study in healthy participants.
No. ABI-6250 is an investigational small molecule and has not been approved by the FDA. It is currently in Phase 2 clinical development for chronic hepatitis D virus infection, with Phase 1 studies also conducted in healthy participants and in participants with mild hepatic impairment.