Respiratory - September 2020

Respiratory - September 2020

Verona Pharma published and presented Part A Phase 2b symptom data and initiated multiple dose part of Phase 2 trial of Ensifentrine in COPD

Ensifentrine (RPL554, PDE 3 and 4 inhibitor) – Verona Pharma

24 Aug 2020

  • Published detailed analysis of a previously reported Phase 2b clinical trial with nebulized ensifentrine as a maintenance treatment for Chronic obstructive pulmonary disease (COPD) in International Journal of Chronic Obstructive Pulmonary Disease
  • Results from the 4-week 405-patient study, first reported in Mar’18, demonstrated that ensifentrine met the primary endpoint producing clinically and statistically significant improvements in lung function at all doses. In addition, clinically relevant secondary endpoints were met including significant progressive improvements in COPD symptoms 
  • Same Phase 2b data was presented as oral and poster presentation at ERS International Congress 2020 on Sep 8, 2020
  • Oral – Ensifentrine, a dual PDE3/PDE4 inhibitor, improves FEV11regardless of smoking status or history of Chronic bronchitis
    Presenter: Tara Rheault, Vice President, R&D and Global Project Management, Verona Pharma
    • Both Phase 2b studies demonstrated that ensifentrine improved lung function (FEV1) in patients with moderate to severe COPD on either no background or tiotropium background therapy
    • Subgroup analysis demonstrated that ensifentrine broadly provided a similar improvement in peak FEV1 vs placebo regardless of smoking or CB status
  • Poster – Ensifentrine added on to tiotropium significantly improves lung function, symptoms and QoL in symptomatic COPD patients regardless of baseline reversibility
    Presenter: Kathleen Rickard, M.D., Chief Medical Officer, Verona Pharma
    • Demonstrated that nebulized ensifentrine added on to tiotropium over 4 weeks improved lung function, symptoms and quality of life in moderate to severe COPD patients who were either reversible (≥12% and 200 ml) to albuterol and non-reversible (<12% or 200 ml) at screening compared to placebo added on to tiotropium. Importantly, in non-reversible patients, a large, clinically meaningful and statistically significant improvement in QoL as measured by SGRQ‑C Total Score was observed

For full story click here

19 Aug 2020

  • Verona Pharma initiated multiple dose part (Part B, multiple dose crossover trial) of Phase 2 trial evaluating Ensifentrine pMDI formulation in COPD
  • Study design:
    • Patient Population: 30 moderate to severe COPD patients who participated in Part A to continue to Part B at two sites in UK
    • Dose/duration: 300 µg, 1000 µg, 3000 µg of pMDI ensifentrine or placebo BID over one week
    • Primary Endpoint: Improvement in lung function as measured by peak FEV1 with ensifentrine compared to placebo after 7 days of treatment
    • Secondary Endpoints: Safety and tolerability, other lung function measures such as trough FEV1, average FEV1 over 4 and 12 hours, and steady state pharmacokinetic profile of ensifentrine pMDI
  • Results expected in H1’21

For full story click here

Verona looking at strong results in DPI and pMDI

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CI Scientists Remarks: 

  • Ensifentrine is an inhaled, first-in-class, dual inhibitor of the enzymes phosphodiesterase 3 and 4 that combines bronchodilator and anti-inflammatory activities in one compound
  • Affected by COVID-19 pandemic, Verona has postponed the Part B enrollment after data from prior studies demonstrated significant and clinically meaningful improvements in both lung function and COPD symptoms; They have move Phase 3 development to 2023
  • Ensifentrine is being evaluated in Phase 2 with two additional formulations dry powder inhaler (DPI) and pressurized metered-dose inhaler as part of their LCM strategy

– Dr. Kowndinya, CI Scientists

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