Candidate: Ensifentrine

Type: Inhaled dual phosphodiesterase 3 (PDE3) / phosphodiesterase 4 (PDE4) inhibitor shown to act as both a bronchodilator and an anti-inflammatory agent

2021 Status: Verona said January 14 that it completed enrollment in its 45-patient Phase II pilot clinical study (NCT04527471), designed to evaluate the efficacy and safety of ensifentrine delivered via pressurized metered-dose inhaler (pMDI) formulation in U.S. patients hospitalized with COVID-19. The randomized, double-blind, parallel group pilot trial—a single center study at University of Alabama at Birmingham (UAB)—will assess pMDI ensifentrine added on to standard of care treatment in patients with COVID-19 compared to standard of care plus placebo. The primary endpoint is the proportion of patients recovered from COVID-19 and no longer hospitalized at Day 29.

Verona is on track to report topline results in the second quarter of 2021, President and CEO David Zaccardelli, PharmD, stated.

2020 Status: On August 14, Verona received FDA approval for its IND application to study its lead candidate ensifentrine in patients with COVID-19. The company said it planned to launch a randomized, double-blind, placebo-controlled pilot clinical study to evaluate ensifentrine delivered via pMDI as a treatment for patients hospitalized with COVID-19 at UAB. Verona cited clinical data from prior studies of ensifentrine in other respiratory diseases, which it said showed that the drug improved lung function and reduced cellular markers of inflammation in the lungs. The company envisions ensifentrine as a treatment for other respiratory diseases including COPD, cystic fibrosis, and asthma.

COVID-19: 300 Candidates and Counting

To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types:


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