Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
UV-4B · 1 trial · 1 indication
TEAEs are those AEs occurring only after administration of investigational product
Subjects with AEs considered serious by the investigator
Number of subjects in a treatment group, who had a vital sign value of toxicity Grade 1 or higher: supine and standing systolic blood pressure (BP), supine and standing diastolic BP, supine and standing pulse rate, respiratory rate, and temperature
Number of subjects in a treatment group with outlier ECG findings: QTcF (Fridericia's), PR, and QRS intervals
Number of subjects with Grade 1 toxicity or higher for hematology, coagulation, chemistry and urinalysis analytes. ULN=upper limit of normal; WBC=white blood cell count.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 - 3 mg UV-4B | EXPERIMENTAL | Subjects receiving UV-4B 3 mg oral solution or placebo |
| Cohort 2 - 10 mg UV-4B | EXPERIMENTAL | Subjects receiving UV-4B 10 mg oral solution or placebo |
| Cohort 3- 30 mg UV-4B | EXPERIMENTAL | Subjects receiving UV-4B 30 mg oral solution or placebo |
| Cohort 4 - 90 mg UV-4B | EXPERIMENTAL | Subjects receiving UV-4B 90 mg oral solution or placebo |
| Cohort 5 - 180 mg UV-4B | EXPERIMENTAL | Subjects receiving UV-4B 180 mg oral solution or placebo |
| Cohort 6 - 360 mg UV-4B | EXPERIMENTAL | Subjects receiving UV-4B 360 mg oral solution or placebo |
| Cohort 7 - 720 mg UV-4B | EXPERIMENTAL | Subjects receiving UV-4B 720 mg oral solution or placebo |
| Cohort 8 - 1000 mg UV-4B | EXPERIMENTAL | Subjects receiving UV-4B 1000 mg oral solution or placebo |
| Name | Type | Description |
|---|---|---|
| UV-4B 3 mg | DRUG | Oral solution, single dose |
| UV-4B 10 mg | DRUG | Oral solution, single dose |
| UV-4B 30 mg | DRUG | Oral solution, single dose |
| UV-4B 90 mg | DRUG | Oral solution, single dose |
| UV-4B 180 mg | DRUG | Oral solution, single dose |
| UV-4B 360 mg | DRUG | Oral solution, single dose |
| UV-4B 720 mg | DRUG | Oral solution, single dose |
| UV-4B 1000 mg | DRUG | Oral solution, single dose |
| Placebo | DRUG | Oral solution, single dose |
Inclusion Criteria: * Healthy subjects * Women: non-pregnant, non-lactating; if of childbearing potential, on specified contraception measures during the study period * Men: using barrier contraception measures during the study period Exclusion Criteria: * Health conditions * Taking prescription ...
Top 8 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 7 | PHASE3 | Arexvy, Shingrix |
| Valneva SE Sponsored ADR | VALN | 5 | PHASE3 | VLA1553 |
| Sinovac Biotech Ltd. | SVA | 3 | PHASE3 | low dose Bivalent Enterovirus Vaccine, Inactivated, Enterovirus Type 71 Vaccine, Inactivated, hexavalent reassortant rotavirus attenuated live vaccine |
| Verrica Pharmaceuticals Inc. | VRCA | 2 | PHASE3 | Cantharidin |
| Moderna, Inc. | MRNA | 4 | PHASE1 | mRNA-1195.1, mRNA-1195.2, mRNA-1189, mRNA-1195, mRNA-1345 |
| Cocrystal Pharma Inc | COCP | 1 | PHASE1 | CDI-988 |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | Inmazeb |
| Dynavax Technologies Corporation | DVAX | 1 | PHASE1 | Z-1018 |
UV-4B is an investigational small molecule antiviral being developed by Emergent BioSolutions Inc. (ticker: EBS) for viral infection. It is in Phase 1 clinical development and has been studied in a single completed trial. UV-4B is also known as UV-4B 3 mg.
UV-4B is being developed for the treatment of viral infection. It is an investigational therapy and has not been approved for any indication. Its only clinical trial enrolled healthy adult volunteers to assess safety, tolerability, and pharmacokinetics rather than to test efficacy in patients.
UV-4B is being developed by Emergent BioSolutions Inc., which trades under the ticker EBS. The company is the sponsor of the Phase 1 trial of UV-4B.
UV-4B is in Phase 1 clinical development. It has completed one Phase 1 trial and has no active trials. UV-4B is investigational and has not been approved by the FDA for any indication.
UV-4B has been studied in one completed Phase 1 trial, NCT02061358, titled "Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects." The trial enrolled 64 healthy volunteers in the United States and was randomized, double-blind, and controlled.