VERONA PHARMA PLC ENHANCE-1 Phase 3 data
December 2022
Nasdaq: VRNA | www.veronapharma.com
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Pivotal Phase 3 program
Two efficacy and safety studies: ENHANCE-1 and ENHANCE-2
Ensifentrine as a Novel inHAled Nebulized COPD thErapy in moderate to severe COPD
Ensifentrine | Long-term safety | |
ENHANCE-1 | 3mg BID N=500 | N=300 |
N=800 | Reporting today | |
Placebo BID N=300 | Long-term safety | |
N=100 | ||
Ensifentrine |
ENHANCE-2 | 3mg BID N=500 | Reported in | |
August 2022 | |||
N=800 | |||
Placebo BID N=300 | |||
24 Weeks | 48 Weeks |
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Patient population:
- LAMA or LABA background allowed (approx. 50% of trial population) and ICS (approx. 20% of population)
- 30-70%predicted FEV1
- Symptomatic (mMRC ≥ 2)
Additional information:
- Long-termsafety in ENHANCE-1
- Sites in North America, Europe and Asia
ENHANCE-1 baseline characteristics
Demographics and baseline characteristics well balanced between groups
Parameter | Ensifentrine | Placebo | Total | ||
n=479 | n=284 | n=763 | |||
Age, mean (SD) | 65.1 (7.1) | 64.9 (7.7) | 65.0 (7.4) | ||
Gender, % Male, n (%) | 275 (57.4) | 167 (58.8) | 442 | (57.9) | |
Moderate / Severe COPD, n (%) | 295 (61.6) / 180 (37.6) | 164 (57.7) / 119 (41.9) | 459 (60.2) / 299 (39.2) | ||
Mild / Very Severe COPD, n (%) | 1 (0.2) / 3 (0.6) | 0 / 0 | 1 (0.1) / 3 (0.4) | ||
% Predicted FEV1 mean, (SD) | 52.9 (10.3) | 51.7 (10.6) | 52.5 (10.4) | ||
% with Chronic Bronchitis, n (%) | 387 (80.8) | 216 (76.1) | 603 | (79.0) | |
% Current Smokers, n (%) | 269 (56.2) | 164 (57.7) | 433 | (56.7) | |
Background Meds: Yes, n (%) | 318 (66.4) | 185 (65.1) | 503 | (65.9) | |
LAMA | 138 (28.8) | 71 | (25.0) | 209 | (27.4) |
LAMA/ICS | 4 (0.8) | 3 | (1.1) | 7 (0.9) | |
LABA | 89 (18.6) | 45 | (15.8) | 134 | (17.6) |
LABA/ICS | 87 (18.2) | 66 | (23.2) | 153 | (20.1) |
E-RS Baseline, mean (SD) | 14.1 (6.8) | 13.3 (6.1) | -- | ||
SGRQ Baseline, mean (SD) | 48.1 (18.3) | 46.9 (17.1) | -- | ||
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Phase 3 ENHANCE-1 data on file
Primary endpoint met in Phase 3 ENHANCE-1
Significant and clinically meaningful improvements in lung function at Week 12
N=760 | +147 mL (p<0.0001) peak FEV1 |
vs placebo |
FEV mean change from baseline, mL 1
130
80
30
-20
-70
+87 mL (p<0.0001) average FEV1 AUC over 12 hours
vs placebo
+35 mL (p=0.0421) morning trough FEV1 Ensifentrine 3 mg vs placebo
placebo
0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | |||||||||||||||||
Time post dose, h | |||||||||||||||||||||||||||||
Ensifentrine 3 mg | placebo | ||||||||||||||||||||||||||||
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Phase 3 ENHANCE-1 data on file
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Verona Pharma plc published this content on 20 December 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 December 2022 14:48:04 UTC.
