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Details:
The proceeds will support Verona’s planned commercial launch of RPL554 (ensifentrine), Verona Pharma’s first-in-class product candidate, which is under review by the US FDA for the maintenance treatment of chronic obstructive pulmonary disease.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Oxford Finance
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing January 02, 2024
Details:
RPL554 (ensifentrine) is a selective, dual inhibitor of the enzymes phosphodiesterase 3 and 4 combining bronchodilator and NSAID activities in one compound. This activity has the potential to provide anti-inflammatory benefits for those with COPD.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2023
Details:
RPL554 (ensifentrine) is a selective, dual inhibitor of the enzymes phosphodiesterase 3 and 4 combining bronchodilator and NSAID activities in one compound. This activity has the potential to provide anti-inflammatory benefits for those with COPD.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 27, 2023
Details:
RPL554 (ensifentrine) is a selective, dual inhibitor of the enzymes phosphodiesterase 3 and 4 combining bronchodilator and NSAID activities in one compound. This activity has the potential to provide anti-inflammatory benefits for those with COPD.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 10, 2023
Details:
Ensifentrine is a selective, dual inhibitor of the enzymes phosphodiesterase 3 and 4 combining bronchodilator and NSAID activities in one compound. This activity has the potential to provide anti-inflammatory benefits for those with COPD.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2023
Details:
Ensifentrine (RPL554) is an investigational, first-in-class, selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 that combines bronchodilator and anti-inflammatory activities in one compound.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2022
Details:
RPL554 (ensifentrine), met the primary endpoint in ENHANCE-2 demonstrating a statistically significant and clinically meaningful improvement in lung function. In addition, ensifentrine significantly reduced the rate of COPD exacerbations in the ENHANCE-2 trial.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2022
Details:
The non-dilutive capital provides further financial flexibility and support for commercialization activities for ensifentrine (RPL554), the first-in-class product candidate, which reported positive Phase 3 data in the ENHANCE-2 trial in chronic obstructive pulmonary disease.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Oxford Finance LLC
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing October 17, 2022
Details:
RPL554 (ensifentrine) met primary endpoint in ENHANCE-2 demonstrating a statistically significant and clinically meaningful improvement in lung function,significantly reduced the rate of COPD exacerbations in the ENHANCE-2 trial.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Nuance Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 19, 2022
Details:
Ensifentrine (RPL554) is an investigational, first-in-class, dual inhibitor of the enzymes phosphodiesterase 3 and 4 ("PDE3" and "PDE4") that combines bronchodilator and anti-inflammatory activities in one compound.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Verona Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 18, 2022
Details:
Subjects receiving RPL554 (ensifentrine) demonstrated a 42% reduction in the rate of moderate to severe COPD exacerbations over 24 weeks compared to those receiving placebo (p=0.0109).
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 09, 2022
Details:
RPL554 (ensifentrine) combines bronchodilator and anti-inflammatory properties in one compound and has the potential to be an effective treatment for COPD and other respiratory diseases, including asthma and cystic fibrosis.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: IQVIA
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 08, 2022
Details:
In prior clinical studies in COPD, RPL554 (ensifentrine) has shown significant and clinically meaningful improvements in lung function, symptoms and quality of life as a monotherapy or added onto a maintenance bronchodilator.
Lead Product(s): Ensifentrine
Therapeutic Area: Infections and Infectious Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2022
Details:
Study results, demonstrated no clinically relevant effects in measures of cardiac conduction including QTcF, PR and QRS intervals were observed with either 3 mg or 9 mg inhaled RPL554 (ensifentrine) dose at any time point over 24 hours.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 09, 2022
Details:
RPL554 (ensifentrine), a first-in-class product that combines bronchodilator and anti-inflammatory activities, has shown significant and clinically meaningful improvements in lung function, symptoms, and quality of life for the treatment of COPD.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 24, 2022
Details:
ENHANCE-2 screening complete with full enrollment expected in january 2022 for RPL554 (Ensifentrine)which has shown significant and clinically meaningful improvements in lung function, symptoms, and quality of life as a monotherapy or added onto a maintenance bronchodilator.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 05, 2022
Details:
RPL554 (Ensifentrine) met all safety objectives in a thorough study designed to evaluate effects on cardiac conduction in healthy individuals for the treatment of chronic obstructive pulmonary disease.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 16, 2021
Details:
The data are consistent with results for dry powder inhaler (“DPI”) and nebulizer formulations of ensifentrine. Ensifentrine is an investigational, first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (“PDE3” and “PDE4”).
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2021
Details:
Ensifentrine (RPL554) is an investigational, first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (“PDE3” and “PDE4”). Verona Pharma has granted Nuance Pharma the exclusive rights to develop and commercialize ensifentrine in Greater China.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Nuance Pharma
Deal Size: $219.0 million Upfront Cash: $40.0 million
Deal Type: Collaboration June 10, 2021
Details:
The abstracts include a new subgroup analysis evaluating the effect of ensifentrine by COPD severity from the 4-week Phase 2b study, first reported by Verona Pharma on January 13, 2020, with nebulized ensifentrine as a maintenance treatment for COPD.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 04, 2021
Details:
The trial was not designed or sized to demonstrate clinical efficacy and no clinical efficacy benefit with ensifentrine treatment added on to standard of care was observed in the trial. One patient death was reported in the ensifentrine treatment group.
Lead Product(s): Ensifentrine
Therapeutic Area: Infections and Infectious Diseases Product Name: RPL554
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 23, 2021
Details:
Ensifentrine delivered by pMDI met all of the primary and secondary lung function endpoints in the 7 day, Phase 2 clinical trial.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: IQVIA
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 02, 2021
Details:
Clinical data from studies of ensifentrine in the treatment of other respiratory diseases have shown ensifentrine improved lung function, reduced inflammation in the lungs* and reduced symptoms of cough and sputum production.
Lead Product(s): Ensifentrine
Therapeutic Area: Infections and Infectious Diseases Product Name: RPL554
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 14, 2021
Details:
The non-dilutive capital provides further financial flexibility to support pre-commercialization activities for ensifentrine, the Company’s first-in-class product candidate, Ensifentrine, which is currently in Phase 3 trials.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Silicon Valley Bank
Deal Size: $30.0 million Upfront Cash: Undisclosed
Deal Type: Financing November 23, 2020
Details:
If successful, the data will support the submission of a New Drug Application in the U.S. for nebulized ensifentrine for the maintenance treatment of COPD.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 23, 2020
Details:
Ensifentrine meaningfully improved COPD symptoms in only 4 weeks, with the largest effect on breathlessness, across two different assessment tools, the E-RS™: COPD breathlessness subscale and the Transitional Dyspnea Index (TDI)*.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2020
Details:
The study will evaluate the effect of ensifentrine on key outcomes in hospitalized COVID-19 patients including facilitation of recovery from the viral infection, clinical status improvement and reduction in supplemental oxygen use and progression to mechanical ventilation.
Lead Product(s): Ensifentrine
Therapeutic Area: Infections and Infectious Diseases Product Name: RPL554
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2020
Details:
Subgroup analysis of Phase 2b data will be provided by Verona Pharma showing that nebulized ensifentrin as monotherapy or applied to tiotropium enhances lung function in moderate to serious COPD patients regardless of smoking status or chronic bronchitis history over 4 weeks.
Lead Product(s): Ensifentrine,Tiotropium Bromide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2020
Details:
Company has initiated second, multiple dose, part of a Phase 2 trial to evaluate the pressurized metered-dose inhaler formulation of ensifentrine in patients with moderate to severe chronic obstructive pulmonary disease.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RPL554
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 19, 2020
Details:
Verona Pharma intends to use the net proceeds from the Financing primarily to fund its Phase 3 clinical program ENHANCE in chronic obstructive pulmonary disease and for general corporate purposes. The Phase 3 clinical trials are planned to start later in 2020.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: RA Capital Management
Deal Size: $183.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement July 17, 2020
Details:
The FDA’s comments follow its review of the End-of-Phase 2 briefing package that included data from 16 clinical trials involving over 1,300 subjects as well as supportive nonclinical and product development data.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 14, 2020
Details:
Analysis supports ensifentrine’s efficacy in COPD as monotherapy and on top of standard of care treatment in patients who remain symptomatic.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 01, 2020
Details:
Results from the single dose part of the study demonstrated a statistically significant and clinically meaningful increase in lung function as measured by forced expiratory volume in one second.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2020
Details:
Paper demonstrates ensifentrine’s potential in improving lung function and quality of life symptoms
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2020
Details:
Primary endpoint met at all doses: ensifentrine produced clinically and statistically significant dose-dependent improvements in lung function.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 13, 2020
Details:
Phase 2b dose-ranging study is evaluating nebulized ensifentrine as an add-on to treatment with a long acting bronchodilator in patients with moderate-to-severe COPD.
Lead Product(s): Ensifentrine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 10, 2020
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