RNS :) :) :)7 Sep 2017 08:22
Verona Pharma plc Verona Pharma Announces Positive Top-Line Data From Phase 2a Clinical Trial In Copd With Rpl554 Dosed In Ad...07/09/2017 7:00amUK Regulatory (RNS & others)
TIDMVRP Achieved significant and clinically meaningful additional improvement in peak lung function and faster onset-of-action when added to tiotropium Demonstrated statistical significance across all primary and secondary efficacy outcome measures, at 6 mg dose; a clear dose response compared to 1.5 mg dose Management to hold conference call and webcast today at 8 am EDT time / 1 pm BST LONDON, Sept. 07, 2017 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM:VRP) (NASDAQ:VRNA) ("Verona Pharma"), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory diseases, announces today positive top-line results from its Phase 2a clinical trial, in which RPL554 was dosed in addition to tiotropium (Spiriva(R) ), one of the most commonly used drugs to treat chronic obstructive pulmonary disease (COPD). In summary, despite the limited number of patients, 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 (FEV(1) ) on the third day of dosing and the average FEV(1) 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. Highlights -- Primary outcome measures 1 : -- RPL554, compared to placebo, produced a statistically significant (1.5 mg, p=0.002; 6 mg, p<0.001) and a clinically meaningful (>100 ml) peak FEV1 on the third day of dosing (additional bronchodilation) when administered on top of the standard bronchodilator tiotropium (Spiriva(R)). -- Average FEV1 on the third day of dosing (0 - 12 hours) of RPL554 when added on top of tiotropium was larger than that of tiotropium alone (1.5mg, p=0.099; 6 mg, p<0.001). -- Secondary outcome measures: -- Both doses of RPL554 produced a statistically significant faster onset of action2 (1.5 mg, 4.2 min; 6 mg, 4.6 min) when added to tiotropium compared to tiotropium alone (37.6 min; p<0.001) -- The administration of RPL554 as an add-on treatment to tiotropium caused a marked reduction in Functional Residual Capacity (1.5 mg, p<0.01