Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ensifentrine Dose 1 · 1 trial · 3 indications
Recovery = first day on which subject satisfies one of the following categories: not hospitalized, no limitations of activities; or not hospitalized, limitation of activities, home oxygen requirement, or both.
| Arm | Type | Description |
|---|---|---|
| Ensifentrine + Standard of Care | ACTIVE_COMPARATOR | 30 subjects randomized to receive blinded, inhaled ensifentrine in addition to standard of care treatment for COVID-19 infection |
| Placebo + Standard of Care | PLACEBO_COMPARATOR | 15 subjects randomized to receive blinded, inhaled placebo in addition to standard of care treatment for COVID-19 infection |
| Name | Type | Description |
|---|---|---|
| Ensifentrine Dose 1 | DRUG | Study drug delivered twice daily via pMDI |
| Placebo pMDI | DRUG | Placebo delivered twice daily via pMDI |
Inclusion Criteria: * Capable of giving informed consent indicating that they understand the purpose of the study and study procedures and agree to comply with the requirements and restrictions listed in the informed consent form and in this protocol. * Patient must be at least 18 years of age and ...
Ensifentrine Dose 1 refers to a dose of ensifentrine, a small molecule drug developed by Verona Pharma plc (ticker VRNA). It was studied in a Phase 2 trial in hospitalized patients with COVID-19. Ensifentrine is an investigational agent and is not approved for this use.
Ensifentrine Dose 1 was studied for the treatment of Coronavirus Infection, specifically COVID-19 and SARS-CoV-2, in hospitalized patients. The research was conducted in a Phase 2 clinical trial. It is an investigational use and has not been approved.
Ensifentrine Dose 1 targets the phosphodiesterase enzymes PDE3A, PDE3B, PDE4A, PDE4B, PDE4C, and PDE4D. It acts as an inhibitor of these targets. This mechanism was being evaluated in the context of Coronavirus Infection.
Ensifentrine Dose 1 is developed by Verona Pharma plc, which trades under the ticker VRNA as a sponsored ADR. The company sponsored the Phase 2 trial of this drug in hospitalized COVID-19 patients.
Ensifentrine Dose 1 is in Phase 2 development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 2 trial has been completed.
Ensifentrine Dose 1 was evaluated in a single completed Phase 2 trial, NCT04527471, titled a pilot study of ensifentrine or placebo delivered via pMDI in hospitalized patients with COVID-19. The trial enrolled 45 participants in the United States and was randomized, double-blind, and placebo-controlled.