13 September 2016, Cardiff – Verona Pharma plc (AIM: VRP.L), the drug development company focused on first-in-class medicines to treat respiratory diseases, today announces its interim results for the six months ended 30 June 2016.
· Reported positive results from “add-on” Phase 2 study with RPL554 in COPD patients. Data continues to suggest drug could be a meaningful new addition, alone or in combination, for the treatment of COPD
o Primary objective of study met; RPL554 produced a highly significant (P≤0.001) and a clinically meaningful additional (>50%) bronchodilation on top of the administered standard of care bronchodilators, salbutamol or ipratropium bromide
o The bronchodilator effects seen with the combinations were significantly (P≤0.001) larger than those of either salbutamol or ipratropium bromide alone, which were in turn all significantly greater than placebo
o Secondary objectives also met; the combination of RPL554 with salbutamol or ipratropium bromide caused a significant reduction (p=0.0002 and p=0.004 respectively) in trapped air in the lung (residual volume) as compared to salbutamol or ipratropium bromide alone, suggesting that RPL554 treatment may reduce dyspnea, a major debilitating symptom of COPD1
o Consistent with previous studies, RPL554 was well tolerated both alone and in combination
§ No effect on vital signs or ECG parameters
§ No gastro-intestinal adverse events recorded
o Primary objective of study met; nebulized RPL554 demonstrated a dose-dependent bronchodilator response in asthma patients; the response was highly statistically significant (p<0.0001) at all doses tested
o The maximum bronchodilator effect of RPL554 in this study was comparable to the effect observed with the supramaximal dose (7.5mg) of nebulized salbutamol used in the study
o Large dose range (0.4 to 24mg) examined; suggests RPL554 potentially has a large safety margin
o RPL554 did not elicit any serious adverse events or adverse events of concern at any dose
§ Fewer adverse events recorded with RPL554 than with nebulized salbutamol
§ No gastro-intestinal adverse events or cardiovascular events of concern
o Studies continue to demonstrate the excellent bronchodilator properties of RPL554
o Formulation is much better tolerated than the earlier solution formulation prototype, with no maximum tolerated dose observed even at 16 times the active bronchodilator dose
o New formulation is suitable for twice daily dosing
o Formulation provides for a longer pulmonary residence time, lower peak plasma exposure and longer half-life in blood than the earlier formulation suggesting a more pronounced effect locally in the lung and comparatively less effects in other organs in the body
POST PERIOD AND OTHER EVENTS
o The net proceeds of the Placing of £41.9 million will predominantly be used to progress RPL554 through a Phase 2b clinical trial in COPD patients, and to fund additional clinical Phase 2 studies in COPD and cystic fibrosis as well as further supportive pre-clinical work
o The cornerstone investors in the Placing are specialist healthcare focused funds Vivo Capital, OrbiMed and Edmond de Rothschild Investment Partners
o Other new investors include New Enterprise Associates, Novo A/S, Abingworth and Aisling Capital with participation of existing investors including Arix Bioscience, Hargreave Hale and Polar Capital
· On 29 July 2016, three additional Non-Executive Directors joined the Verona Pharma Board as representatives of certain of the investors in the Placing: Mahendra Shah (Vivo Capital), Rishi Gupta (Orbimed) and Andrew Sinclair (Abingworth)
· On 12 September 2016, Vikas Sinha joined the Verona Pharma Board as an independent Non-Executive Director
· Clinical data from Phase 2a “add on” study with RPL554 presented at the European Respiratory Society (ERS) 2016 International Conference in London
Dr. Jan-Anders Karlsson, CEO of Verona Pharma commented: “We have continued to make excellent progress with the clinical development of RPL554. The headline data reported from the two clinical trials during the period continues to support our belief that this first-in-class drug could be a meaningful new treatment for COPD patients.
“The recent fund raise is a significant milestone in the Company’s history which allows us to continue development in later stage Phase 2 trials. The fundraising has also brought a number of specialist healthcare investors as new shareholders. Several of them have now joined our Board and we look forward to benefiting from their multi-faceted experience in the sector.”
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Last updated on: 13/09/2016
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