Theravance Biopharma and Mylan Report Additional Phase 3 Data for Revefenacin (TD-4208) in Several Presentations at 2017 ATS
Phase 3 Pivotal Study Presentations
Researchers presented new data from the completed three-month Phase 3 studies, which included more than 1,250 patients with moderate to very severe COPD, in two separate presentations at the 2017 ATS meeting. The first presentation, which focused on efficacy outcomes, demonstrated statistically significant and clinically meaningful improvements over placebo in trough forced expiratory volume in one second (FEV1) and in overall treatment effect on trough FEV1 (OTE FEV1) after 12 weeks of dosing in each study and for each of the revefenacin doses studied (88 mcg once daily and 175 mcg once daily). The improvements in trough FEV1, the primary efficacy endpoint, versus placebo for the intent-to-treat populations across both studies were 118 mL and 145 mL for 88 mcg and 175 mcg, respectively (p ≤ 0.001). Additionally, the improvements in OTE FEV1, a key secondary endpoint, versus placebo for the intent-to-treat population across both studies were 112 mL and 139 mL for 88 mcg and 175 mcg, respectively (p ≤ 0.001).
The second presentation featured safety and tolerability data from the two completed three-month Phase 3 studies. Both doses of revefenacin had comparable rates of adverse events to placebo, low rates of serious adverse events, and no clinically meaningful differences in blood parameters or electrocardiogram (ECG) data, across all treatment groups (active and placebo). As previously reported, the most commonly reported adverse events, across both trials and across all treatment groups, were exacerbations, cough, dyspnea and headache. There were no reports of blurred vision, narrow-angle glaucoma or worsening of urinary retention. Reports of dry mouth were < 0.5% in the revefenacin treatment arms.
"These presentations build upon the topline results that we announced last October and further confirm that revefenacin may offer meaningful benefits to patients with moderate to very severe COPD," said
Revefenacin is being developed as a once-daily, nebulized bronchodilator for the treatment of patients with COPD and will be compatible with a range of jet nebulizers. The three-month Phase 3 pivotal studies were replicate, randomized, double-blind, placebo-controlled, parallel-group trials designed to provide pivotal efficacy and safety data for once-daily revefenacin over a dosing period of 12 weeks. The replicate studies enrolled a combined total of over 1,250 patients in the
The revefenacin Phase 3 program also includes an ongoing 12-month, open-label, active comparator safety study in more than 1,050 patients, which is expected to be completed in mid-2017. Together, the three studies enrolled approximately 2,300 patients. Should outcomes from the safety study be supportive,
Additional Data Presentations
In a separate presentation at 2017 ATS, researchers reported baseline data on the prevalence of COPD patients with low peak inspiratory flow rate (PIFR) who are enrolled in the ongoing 12-month, open-label, active comparator safety study of revefenacin. Of the total population of 1,080 patients who were enrolled in the study, 448 patients had their PIFR measured using a commercially available, easy-to-use instrument (InCheck®) at the time of study randomization. Researchers categorized PIFRs of less than 40 L/min against the resistance of the Handihaler® as "low" for the means of this analysis based upon published research and reference data. Presented results showed that 24% of subjects had a low PIFR rate at the time of randomization. Analysis of patient characteristics showed that patients with a low PIFR tended to be female and exhibited evidence of more severe COPD, although a proportion of patients with less severe COPD were also found to have low PIFR.
"Patients with low PIFR may not be able to breathe in with enough force to benefit from the use of handheld COPD devices. There is growing evidence that these patients may have better short-term and long-term benefits from nebulized therapy. This is supported by a recent scientific study that reported that patients with low PIFR, regardless of disease severity, showed statistically significant lower COPD hospital readmission rates within both 30 and 90 days when using nebulized therapy as compared to a handheld product following COPD exacerbation1," said
Researchers also presented results from a study highlighting the pharmacological properties of revefenacin in isolated tissue airways, from both rats and humans, to enable preclinical to clinical translation of the in vivo findings in rats. Study data demonstrated that revefenacin produced potent and persistent anti-muscarinic activity in the airway tissues of both rats and humans. These translational findings are consistent with clinical data from the replicate three-month Phase 3 studies of revefenacin demonstrating 24-hour bronchodilatory effects in COPD patients.
COPD is a growing and devastating disease that is the third leading cause of death in the
Revefenacin (TD-4208) is a novel investigational once-daily nebulized LAMA in Phase 3 development for the treatment of moderate to very severe COPD. Market research by
Our pipeline of internally discovered product candidates includes potential best-in-class medicines to address the unmet needs of patients being treated for serious conditions primarily in the acute care setting. VIBATIV® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the
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This press release includes statements that constitute "forward-looking statements," including with regard to revefenacin having the potential to offer meaningful benefits to patients with moderate to very severe COPD; revefenacin being positioned favorably as a potentially key therapeutic option for COPD patients if approved, particularly as revefenacin would represent the first once-daily nebulized bronchodilator for COPD; anticipated completion of the ongoing Phase 3 safety trial of revefenacin in mid-2017 with the goal of filing an NDA by the end of 2017; revefenacin having the potential to help address an unmet medical need for patients; revefenacin representing a key contributor in Mylan's pipeline of promising respiratory products, and supporting the growth of Mylan's respiratory franchise; Mylan's belief that it is well-positioned to support the commercial success of the
product; the ongoing 12-month, open-label, active comparator safety study in more than 1,050 patients, which is expected to be completed in mid-2017;
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1 Loh CH, Lovings T, Ohar J. Long acting nebulized agents decrease readmissions in patients with suboptimal peak inspiratory flow. Chest 2016;150:925A-925A.
4 TBPH market research (N = 160 physicians); Refers to US COPD patients
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