Key Data From Newly-Tested PAH Drug To Be Presented at European Conference

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AMBITION PAH clinical trial

AMBITION PAH clinical trialThe first results of AMBITION, a large pulmonary arterial hypertension clinical trial, will be presented this month at the European Respiratory Society (ERS) International Congress 2014, as part of the highlights of the meeting.

AMBITION is a randomized, double blind, multi center Phase 4 clinical trial testing the efficacy of Ambrisentan (marketed as Letairis), an endothelin-receptor agonist (Gilead and GlaxoSmithKline) and Tadalafil, a phosphodiesterase-5 inhibitor (marketed as Adcirca by Lung Biotechnology), both in combination and as mono therapy, in the treatment of pulmonary hypertension. Individually, each of these drugs have already been shown to improve 6-minute walking distance, and now researchers hope that this effect will be amplified upon combination therapy.

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The ERS meeting will also include a discussion about new therapeutic approaches towards pulmonary arterial hypertension (PAH), including updates and results from studies of pirfenidone and nintedanib, two drugs in late-stage clinical development for the treatment of idiopathic pulmonary fibrosis, a condition often associated with PAH.

In addition to the key data for the AMBITION trial for PAH, guidelines for the treatment and diagnosis of severe asthma will also be released both by the ERS and by the American Thoracic Society, further discussing the emerging risk factors for asthma and chronic obstructive pulmonary disease (COPD), such as air pollution, smoking, obesity and poverty.

“There’s a big problem in terms of socioeconomic factors; patients are consuming a substantial portion of the budget for asthma in different parts of the world. Most of the studies of risk factors have been conducted in Europe and the United States, which is home to just 1 billion of the world’s 7 billion or so occupants. We don’t know what the risk factors are in less developed countries. Living in extreme environmental conditions is not playing a major role in these affluent groups in the suburbs of American cities or in Europe,” Carlos Baena-Cagnani, MD, president of the Interasma Global Asthma Association and director of the Centre for Research in Respiratory Medicine at Catholic University of Cordoba, Argentina, said in a Medscape interview.

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Several presentations in the ERS meeting will show different asthma and COPD treatments currently in late-stage clinical development. Even though there have been several clinical efforts, respiratory health is still an enormous public health challenge, with COPD ranked as the third leading cause of death and with no noninfectious lung disease able to be cured yet.

Both PH and COPD represent lung-related diseases with substantial unmet needs for viable treatments. As a result, the data that is set to be released at this year’s European Respiratory Society International Congress could play a pivotal role in future therapies for both of these indications.