Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Verekitug (UPB-101), UPB-101
Verekitug · 5 trials · 4 indications
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
An asthma exacerbation is defined as a worsening of asthma that required treatment with systemic (oral or intravenous) corticosteroids for at least three consecutive days or a single depo-injectable dose of corticosteroids or an emergency room (ER) or urgent care visit that required systemic corticosteroids or an admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for greater than or equal to 24 hours.
NPS is a physician-reported scoring system to estimate the extent or severity of nasal polyps (NPs) based on assessments by nasal endoscopy. Each nostril is scored on a categorical scale of 0 to 4 with a lower score indicating smaller-sized nasal polyps. The total score is the sum of the right and left scores (0-8). A higher score means more severe disease.
Overall Summary of Treatment-emergent Adverse Events (TEAEs) and Adverse Events (AEs) up to Week 24 (Safety Population)
| Arm | Type | Description |
|---|---|---|
| Verekitug (UPB-101) 100 mg and Placebo | EXPERIMENTAL | Participants will receive 0.5 milliliter (mL) of the formulated solution (containing 100 milligrams \[mg\] of verekitug \[UPB-101\]) and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 96. |
| Verekitug (UPB-101) 400 mg and Placebo | EXPERIMENTAL | Participants will receive 2.0 mL of the formulated solution (containing 400 mg of verekitug \[UPB-101\]) and 0.5 mL of matching placebo subcutaneously in two separate injections every 24 weeks up to Week 96. Participants will also receive 2.0 mL and 0.5 mL of matching placebo subcutaneously in two separate injections at Weeks 12, 36, 60 and 84 visits. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive 0.5 mL of matching placebo and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 96. |
| Verekitug 100 mg Q12W and Placebo | EXPERIMENTAL | Participants will receive 0.5 mL of verekitug (100 mg) and 2.0 mL of matching placebo, subcutaneous (SC) injections, every 12 weeks (Q12W) for up to 48 weeks. |
| Verekitug 400 mg Q24W and Placebo | EXPERIMENTAL | Participants will receive 2.0 mL of verekitug (400 mg) and 0.5 mL of matching placebo, SC injections, at Weeks 24 and 48 visits. Participants will also receive 2.0 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits. |
| Verekitug (UPB-101): 100 mg Q12W / Placebo | EXPERIMENTAL | Participants will receive 0.5 milliliter (mL) of verekitug (UPB-101) formulated solution (containing 100 milligrams \[mg\] of verekitug \[UPB-101\]) and 2.0 mL of placebo subcutaneously in two separate injections every 12 weeks up to Week 48. |
| Verekitug (UPB-101): 400 mg Q24W / Placebo | EXPERIMENTAL | Participants will receive 2.0 mL of verekitug (UPB-101) formulated solution (containing 400 mg of verekitug \[UPB-101\]) and 0.5 mL of placebo subcutaneously in two separate injections every 24 weeks up to Week 48. Participants will also receive 2 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits. |
| Verekitug (UPB-101): 100 mg Q24W / Placebo | EXPERIMENTAL | Participants will receive 0.5 mL of verekitug (UPB-101) formulated solution (containing 100 mg of verekitug \[UPB-101\]) and 2.0 mL of placebo subcutaneously in two separate injections every 24 weeks up to Week 48. Participants will also receive 2 mL and 0.5 mL of placebo subcutaneously in two separate injections at Weeks 12 and 36 visits. |
| Verekitug (UPB-101) | EXPERIMENTAL | Participants will be administered 0.5 milliliter (mL) of verekitug (UPB-101) formulated solution (containing 100 milligrams \[mg\] of verekitug \[UPB-101\]) subcutaneously, every 12 weeks for 24 weeks. |
| Matching placebo | PLACEBO_COMPARATOR | Participants will be administered verekitug (UPB-101) matching placebo solution, subcutaneously, every 12 weeks for 24 weeks. |
| Active substance 1 | EXPERIMENTAL | UPB-101 Cohort 1 |
| Active substance 2 | EXPERIMENTAL | UPB-101 Cohort 2 |
| Active substance 3 | EXPERIMENTAL | UPB-101 Cohort 3 |
| Active Substance 4 | EXPERIMENTAL | UPB-101 Cohort 4 |
| Name | Type | Description |
|---|---|---|
| Verekitug | DRUG | Verekitug (UPB-101) formulated solution |
| Placebo | OTHER | Matching Placebo to Verekitug (UPB-101) |
| Verekitug (UPB-101) | DRUG | Verekitug (UPB-101) formulated solution |
| UPB-101 | DRUG | Subcutaneous injection |
Inclusion Criteria: * Physician diagnosis of COPD for \>12 months. * Current or former smokers with a smoking history of 10 pack-years or more. * Post-bronchodilator FEV1/ Forced Vital Capacity (FVC) ratio \<0.70 and predicted post-bronchodilator FEV1 \>30% and ≤80%. * Modified Medical Research Cou...
Verekitug is an investigational drug being developed for respiratory conditions, including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, and severe asthma. It is currently in Phase 2 clinical development and has not been approved by any regulatory agency.
Verekitug targets TSLPR, the receptor for thymic stromal lymphopoietin (TSLP). By binding to TSLPR, it is designed to block TSLP signaling, which is involved in airway inflammation. This mechanism is being investigated for its potential to treat inflammatory respiratory diseases such as asthma and COPD.
Verekitug is being developed by Upstream Bio, Inc., a biotechnology company. The company's ticker symbol is UPB. Upstream Bio is focused on developing therapies for inflammatory diseases.
Verekitug is in Phase 2 clinical development. It is an investigational drug and has not been approved for any indication. The Phase 2 program includes trials in COPD, severe asthma, and chronic rhinosinusitis with nasal polyps.
Verekitug is being studied in several Phase 2 trials. Active trials include NCT06981078 in COPD and NCT06966479 (VALOUR) in severe asthma. Completed trials include NCT06196879 (VALIANT) in severe asthma and NCT06164704 in chronic rhinosinusitis with nasal polyps. These trials are randomized, double-blind, and placebo-controlled.
Yes, Verekitug is also known as UPB-101. UPB-101 is the former designation or alternative name for the same investigational drug. Both names refer to the TSLPR-targeting compound developed by Upstream Bio for respiratory indications.