NEW YORK, Sept. 17, 2012 /PRNewswire/ -- Citeline®, an Informa business, reviewed clinical trial data presented at the European Respiratory Society (ERS) conference, held September 1-5, 2012 in Vienna, Austria, noting that classical fixed-dose combination (FDC) treatments remain a focus of industry sponsors, but that novel targeted asthma drugs may also be on the horizon for persistent asthma patients.
Respiratory drug leader GSK presented largely positive results from five pivotal Relvar (formerly Relovair) asthma trials. The results, submitted in July as part of the company's regulatory filing for asthma in the EU, demonstrated improved efficacy and safety. Citeline's Trialtrove® database monitors the development of these novel, once-daily drugs for asthma, and notes that Novartis/Merck's QMF149 program is the closest competitor behind Relvar. However, since the QMF149 program is still in phase II trials and is shifting development to the Breezhaler device, a long road remains before regulatory submission, promising Relvar a spot as the only marketed once-daily inhaled corticosteroid/long-acting beta agonist (ICS/LABA) following its approval.
"In addition to these novel therapies, Trialtrove also monitors generic FDC development, and found the majority of ongoing phase III asthma trials are for generic FDCs administered using new delivery devices, such as Chiesi's NEXThaler, Orion Pharma's Easyhaler and Vectura's Gyrohaler. The classical FDC treatment paradigm remains highly effective for many asthma patients, and more affordable generic versions of these drugs will present strong competition for blockbusters Advair and Symbicort," states Dr. Laura Runkel, Citeline's Associate Director of Autoimmune/Inflammation.
Trialtrove data tracks biologics in development for asthma, and many are now targeting subsets of patients uncontrolled by FDCs. The most numerous candidates in ongoing trials are IL-13 antagonists, including Novartis's QBX258, AstraZeneca's tralokinumab, Sanofi/Regeneron's dupilumab, and Roche's lebrikizumab. In results presented at ERS, Roche demonstrated that lebrikizumab treatment reduced serum periostin in periostin-high subjects. The drug is currently in two large phase III studies for persistent asthma. "Compared with other asthma drugs in the pipeline, lebrikizumab has progressed rapidly through clinical trials," notes Dr. Runkel. "Further setting lebrikizumab apart from its competitors is the fact that Roche is the only sponsor currently employing a companion diagnostic in its asthma trials." The use of a validated companion diagnostic could provide the key advantage in selecting the subset of patients most likely to benefit from IL-13 antagonism. Although companion diagnostics are rarely used in asthma trials, Citeline's Pipeline® product confirms that their use overall is on the rise and is currently tracking 82 companion diagnostics intended for approval with specific drugs.
Citeline provides the world's most comprehensive real-time R&D intelligence to the pharmaceutical industry, covering global clinical trial, investigator and drug intelligence. Our data is drawn from over 20,000 unique sources and analyzed by the industry's largest team – over 250 full-time expert analysts and editors. Our services combine both data and on-demand access to our analysts, to give you up-to-the-minute information and intelligence on which to base critical business decisions. For more information about Citeline visit www.Citeline.com.
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