RPL554 is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 designed to have anti-inflammatory as well as bronchodilator properties, and is currently in development for the maintenance treatment of COPD and for the treatment of cystic fibrosis.
The poster, titled, “RPL554, A First-In-Class Dual PDE3/4 Inhibitor, Causes Rapid Additional Bronchodilation When Dosed with Tiotropium in COPD Patients,” provided a review of the positive data from Verona Pharma’s Phase 2a clinical trial, in which RPL554 was dosed in addition to tiotropium (Spiriva®), one of the most commonly used drugs to treat COPD. In summary, the data from this Phase 2a trial demonstrated significantly improved peak lung function when RPL554 was added to tiotropium in patients with moderate-to-severe COPD.
This was a double blind, placebo-controlled, three way cross-over trial in 30 subjects with COPD and included two different doses of RPL554, 1.5 mg and 6 mg, or placebo, dosed twice-daily for three days, in addition to tiotropium, a long-acting anti-muscarinic (LAMA) bronchodilator, dosed once-daily (ClinicalTrials.gov Identifier: NCT03028142). The primary outcome measures for the trial were peak forced expired volume in one second (FEV1) on the third day of dosing and the average FEV1 on the third day of dosing, representing measures of lung function and duration of effect. A number of secondary outcome measures were also recorded. Of note, the 6 mg dose of RPL554 achieved statistical significance, compared to placebo, on all primary and secondary outcome measures. The data confirmed dose dependency between the two RPL554 doses.
1 In the study, a p-value<0.05 is regarded as statistically significant
2 Defined as FEV1 improvement by ≥10%
This complete block two-way crossover trial evaluated a single dose of RPL554 in 12 healthy volunteers to determine the process of bodily absorption, distribution, metabolism and excretion of this novel therapy, including the swallowed portion of the nebulized dose. The trial was conducted under an Investigational New Drug application accepted by the
With any inhaled or nebulized medication, a portion of the substance is deposited in the mouth and then swallowed by the patient. These results showed that in the study subjects, only 10.4 percent of the inhaled dose entered the bloodstream via the gastrointestinal tract. The low oral bioavailability of nebulized RPL554, as demonstrated in the study, is consistent with optimal inhaled delivery of medications for the treatment of COPD and asthma. Therefore, the results from this study confirmed that inhaled RPL554 is an appropriate form of administration for patients.
“These positive data are further evidence of RPL554’s promising therapeutic potential for the treatment of COPD patients, further supporting Verona’s ongoing clinical development program,” said
3 Dyspnea (shortness of breath) in COPD patients is often associated with hyperinflation of the lungs resulting from a higher residual volume of air
Chronic obstructive pulmonary disease (COPD) is a progressive and life-threatening respiratory disease for which there is no cure.1 The condition damages the airways and the lungs, leading to persistent breathlessness, impacting a person’s daily life and their ability to perform simple activities such as walking a short flight of stairs or carrying a suitcase.1 Although COPD is thought to be underdiagnosed, globally, around 384 million people suffer from the disease.2 This number, according to the
This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the value of the results from the Phase 2a and pharmacokinetic clinical trials, RPL554 as a new complementary treatment for patients with COPD, projected annual medical costs related to COPD, the results of the Phase 2a and pharmacokinetic trials supporting later stage development of RPL554, the future clinical development and positioning of RPL554, and the treatment potential for RPL554.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from our expectations expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history; our need for additional funding to complete development and commercialization of RPL554, which may not be available and which may force us to delay, reduce or eliminate our development or commercialization efforts; the reliance of our business on the success of RPL554, our only product candidate under development; economic, political, regulatory and other risks involved with international operations; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; serious adverse, undesirable or unacceptable side effects associated with RPL554, which could adversely affect our ability to develop or commercialize RPL554; potential delays in enrolling patients, which could adversely affect our research and development efforts; we may not be successful in developing RPL554 for multiple indications; our ability to obtain approval for and commercialize RPL554 in multiple major pharmaceutical markets; misconduct or other improper activities by our employees, consultants, principal investigators, and third-party service providers; material differences between our “top-line” data and final data; our reliance on third parties, including clinical investigators, manufacturers and suppliers, and the risks related to these parties’ ability to successfully develop and commercialize RPL554; and lawsuits related to patents covering RPL554 and the potential for our patents to be found invalid or unenforceable. These and other important factors under the caption “Risk Factors” in our Annual Report on Form 20-F filed with the
2 Adeloye D, Chua S, et al. Global and regional estimates of COPD prevalence: Systematic review and meta–analysis.
4 COPD Foundations. Characteristics of COPD Patients Using United States Emergency Care or Hospitalization. https://journal.copdfoundation.org/jcopdf/id/1103/Characteristics-of-COPD-Patients-Using-United-States-Emergency-Care-or-Hospitalization. Accessed
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