AstraZeneca's Debut Biologic Respiratory Therapy Achieves Positive Results In Phase III trials

AstraZeneca plc (ADR) (NYSE:AZN) saw  its first respiratory biomedicine receive primary and key secondary endpoints in the third phase of clinical trials. The therapy, Benralizumab, when combined with standard medicine was seen to significantly reduce severity of asthma symptoms and enhanced lung function with individuals which harbour an eosinophilic phenotype.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: “Severe asthma affects the lives of millions of patients around the world and can be life threatening. The SIROCCO and CALIMA Phase III trials have shown that Benralizumab can offer a meaningful treatment option for patients as evidenced by reductions in exacerbations, improvement in lung function and symptoms, with the promise of fewer doses a year. Benralizumab has a unique way of working in patients with severe asthma with an eosinophilic phenotype and reflects AstraZeneca’s progress in bringing the next generation of respiratory medicines to patients.

The new biomedicine is an anti-eosinophil monoclonal antibody which targets and incurs almost entire reduction of eosinophils, the initiation of affect is within 24 hours. The eosinophils cells cause inflammation and airway hyper-responsiveness in around half of individuals impacted by asthma. Its forecasted that by 2020 the lifestyles of around 400 million individuals will be affected by Asthma.  

Sirocco and Calima trials examined the impact of two separate dosing methods using Benralizumab in 4 week and 8 week regimes as an add on therapy. The outcomes illustrated that there were up to 51% reductions in the yearly rate of asthma aggravations, improvement in asthma symptoms (for example, chest tightness, shortness of breath). Also, advancements were seen in lung function at 4 weeks after the initial measure of the treatment which was then sustained.

There was a similar probability rate between the occurrence of adverse events found with Benralizumab patients and placebo patients for both Sirocco and Calima. The most frequent effects seen were nasopharyngitis, headache, sinusitis and upper respiratory tract infection.

The EU and US regulatory applications for Benralizumab scheduled to occur later this year will comprise data from the SIROCCO and CALIMA trials. 

Traditionally the pharma industry has lent towards the view of a one-size fits all approach to the application of therapeutics. Now, eyes are set firmly on the notion of personalised medicine. The progression of next generation sequencing and genome technology is allowing for the first tangible personalised therapies to emerge.

However, there are still major strides to be made within molecular diagnostics and the sequencing of genomes. The high price tags attached to some precision medicines have been labelled as a blockade to their application.

Regina Au of BioMarketing Insight stated that the realisation of precision medicines can’t be attributed to a finite level of individuals because it exists as an industry wide culture shift. On this subject, she stated: "The whole industry is striving towards personalized medicine, but getting there is not easy. If you define personalized medicine as "treating the right patient with the right medication," there have been a lot of companies … working on this with the existing medications, for example in the area of breast cancer."

She adds that in striving to understand a disease, "..The industry has realized that in order to accelerate this process for any disease, one has to use biomarkers. However, to find these biomarkers, it wasn't until we had the research tools like Next Generation Sequencing (NGS) for genome sequencing at an affordable price scientist[s] [were then] able to use this technology to move the science forward in trying to understand diseases and develop diagnostic tools."

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