ENTIA NON SUNT MULTIPLICANDA PRAETER NECESSITATEM
William of Ockham 1285-1349 - Ockhams Razor
RESULTS OF A PHASE IIB STUDY
OF INHALED HEPARIN IN MODERATE TO SEVERE COPD PATIENTS
Swanwick, UK, February 11th 2016
Ockham Biotech Limited, a UK based developer of products for the treatment of chronic obstructive pulmonary disease (COPD) and for cystic fibrosis (CF) today announces the results of a study of their patent protected inhaled heparin.
Conducted in Rome, at the IRCCS San Raffaele Pisana hospital, the Phase IIB study investigated the influence of inhaled heparin over 21 days on pulmonary function and exercise capacity amongst 24 moderate to severe COPD patients. Safety parameters were also studied.
The results of this study showed significant increases in lung function as measured by forced expiratory volume in one second (FEV1) and forced vital capacity (FVC), and significantly reduced air trapping as measured by inspiratory capacity (IC), total lung capacity (TLC) and residual volume (RV) against placebo. These results were maintained for at least 7 days after treatment was stopped. Importantly, exercise parameters showed a clinically significant improvement in the distance covered during a 6 minute walking test and a significant reduction in post-exercise dyspnoea.
Inhaled heparin did not induce any serious adverse events, nor were there any negative influences on cardiovascular, coagulation or respiratory parameters during, or after, the study.
Commenting on the results of the study, Professor Mario Cazzola, Chief, Unit of Respiratory Clinical Pharmacology, University of Rome Tor Vergata, stated:
“These results show that inhaled, nebulised unfractionated heparin improves the pulmonary function, air trapping, exercise capacity and dyspnoea in patients with severe COPD, with no significant changes in blood coagulation parameters and a good safety profile. We believe that this development could be a major step forward in helping treat these patients by reducing the risk of exacerbations and hence reducing hospital admissions.”
Professor Janis Shute, scientific director of Ockham, commented:-
“We are really excited by the significant findings from the study which builds on the extensive preclinical work we have undertaken with unfractionated heparin. There is the distinct potential for modification of the COPD disease process and getting closer to the goal of alleviating symptoms in these difficult to treat patients”.
For more details, please contact
Andy Short, CEO and Chairman
as@ockhambiotech.com
EUROPEAN PATENT
The first European patent on the use of inhaled heparin as a mono-therapy (No: 03/068187) was granted to Ockham in 2008. The patent was subsequently opposed by Vectura PLC and was revoked at first instance by the Opposition Division of the European Patent Office in 2011.
In March 2013, the Technical Board of Appeal set aside the first instance decision of the Opposition Division and maintained a European patent with claims directed to administration of heparin via inhalation, intranasally or instillation.