Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ADX-914, bempikibart (ADX-914)
Bempikibart · 3 trials · 3 indications
Part A: Mean relative percent change in SALT score at 24 weeks compared with baseline
Part B: Mean percent change from baseline in SALT score at Week 36
Severity score is based on evaluation of severity of atopic dermatitis in 4 body regions (head and neck, trunk, upper limbs, and lower limbs). The minimum score is 0 (less severe) and maximum score is 72 (most severe).
Listing and summary of AE incidence
Listing of clinically significant changes in PE findings
Listing and change from baseline to end of study
Listing and change from baseline to end of study
Listing and change from baseline to end of study
Change in 12-lead ECG parameters from baseline to end of study
| Arm | Type | Description |
|---|---|---|
| Experimental: bempikibart (ADX-914) | EXPERIMENTAL | 200mg dose of bempikibart (ADX-914) administered via injection under the skin |
| ADX-914 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Experimental: Cohort 1:1 - 1:6 ADX-914 | EXPERIMENTAL | ADX-914 single SC dose |
| Placebo Comparator: Cohort 1:1 - 1:6 placebo | PLACEBO_COMPARATOR | Placebo single SC dose |
| Experimental: Cohort 2:1- 2:3 | EXPERIMENTAL | ADX-914 multiple SC dose once every 2 weeks for 6 weeks |
| Placebo Comparator: Cohort 2:1- 2:3 | PLACEBO_COMPARATOR | Placebo multiple SC dose once every 2 weeks for 6 weeks |
| Name | Type | Description |
|---|---|---|
| bempikibart (ADX-914) | DRUG | Subcutaneous administration of bempikibart (ADX-914) |
| ADX-914 | DRUG | Subcutaneous administration of ADX-914 |
| Placebo | DRUG | Subcutaneous administration of Placebo |
Key Inclusion Criteria: 1. Adult men and women, aged 18 to 75 years, inclusive, at the time of informed consent. 2. Clinical diagnosis of severe to very severe alopecia areata, defined as the presence of ≥50% total scalp hair loss at screening and baseline as measured by the SALT score. Key Exclus...
Bempikibart is an investigational small molecule developed by Q32 Bio Inc. (ticker QTTB) for dermatology indications, specifically alopecia areata and atopic dermatitis. It is in Phase 2 clinical development and has received FDA Fast Track designation. It is also known as ADX-914.
Bempikibart is being evaluated for the treatment of severe alopecia areata in the Phase 2a SIGNAL-AA proof-of-concept trial (NCT06018428), which enrolled 75 adults in the United States and Canada. It is also being studied in moderate to severe atopic dermatitis. Bempikibart is investigational and not approved for any use.
Bempikibart targets IL-7Rα, the alpha subunit of the interleukin-7 receptor, a protein involved in immune cell signaling. By binding this target, the small molecule is designed to modulate immune pathways relevant to inflammatory skin conditions such as alopecia areata and atopic dermatitis.
Bempikibart is developed by Q32 Bio Inc., which trades on the Nasdaq under the ticker QTTB. Q32 Bio is the sponsor of the clinical program evaluating bempikibart, also known as ADX-914, in dermatology indications including alopecia areata and atopic dermatitis.
Bempikibart is in Phase 2 clinical development. Two Phase 2 trials have been conducted: SIGNAL-AA in severe alopecia areata and SIGNAL-AD in moderate to severe atopic dermatitis. A Phase 1 single and multiple ascending dose study in healthy adult volunteers has been completed. Bempikibart is investigational and has not been approved by the FDA.
Bempikibart has been studied in three trials. NCT06018428 is a Phase 2a proof-of-concept trial in severe alopecia areata (SIGNAL-AA), and NCT05509023 is a Phase 2 trial in moderate to severe atopic dermatitis (SIGNAL-AD). NCT04485481 was a completed Phase 1 single and multiple ascending dose study in healthy volunteers.
Yes, bempikibart and ADX-914 are the same investigational drug. ADX-914 is the earlier code name used by Q32 Bio Inc. (ticker QTTB) in its clinical program, and bempikibart is the current name. Trial records for both names refer to the same IL-7Rα targeting small molecule.