New asthma drug promising in trials

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Human clinical trials show exciting promise for a new drug treatment for moderate and severe asthma, with further potential in treating severe eczema.

Dupilumab, developed by Sanofi and Regeneron Pharmaceuticals Inc., reduced asthma attacks by 87 percent in people with a specific type of asthma, when compared with those given a placebo.

Sally E. Wenzel -- a professor in the University of Pittsburgh School of Medicine's division of pulmonary, allergy and critical care medicine -- led and co-authored the study published in the New England Journal of Medicine. As a consultant to Sanofi, she designed the clinical trials to test the drug's effect on asthma and served as principal investigator.

"Our findings suggest that dupilumab holds promise for the treatment of moderate to severe asthma," she said. "It prevents some of the inflammatory pathways [of asthma] from being activated."

The drug must undergo further clinical trials before Sanofi seeks U.S. Food and Drug Administration approval. While the drug could benefit 50 percent of people with asthma, Dr. Wenzel said, its high cost would limit its use to the most severe cases. It likely would benefit about half of those with the most severe forms of asthma.

Dupilumab also has been tested successfully as a treatment for severe eczema, with Sanofi officials noting interest in eventually testing the drug's effectiveness against other severe allergies and atopic skin disorders -- or those involving skin hypersensitivity to allergens -- including eosinophilic esophagitis, food allergies and sinus problems.

"We are eager to continue with human clinical trails, and we are very encouraged with preliminary results," said Gianluca Pirozzi, Sanofi project leader. "The future holds potential in many diseases which we would be interested in expanding into."

The asthma study involved researchers from Pitt, the drug companies, Colorado Allergy and Asthma Centers, California Allergy & Asthma Medical Group Inc., and Peninsula Research Associates. The next phase of human clinical trials will focus on which cases of asthma would benefit most from dupilumab, determine dosage levels and test whether the drug would be safe and effective in the long term.

About 25 million Americans have asthma, with up to 20 percent not having optimal control of the symptoms despite the availability of modern medications, Dr. Wenzel said, saying that group would be top candidates for the new drug.

Asthma is a chronic inflammatory disease of the airways characterized by sensitivity to environmental and biologic factors such as dust, chemicals, smoke, allergens and viral infections, leading to an acute and chronic narrowing of the airway and increased mucus production, a news release states. The impacts include wheezing, shortness of breath, coughing and chest tightness. The worldwide estimates are between 235 million to 300 million people with asthma, with 180,000 deaths annually.

Different underlying causes of asthma are suspected, requiring different treatment approaches, Dr. Wenzel said. Most challenging are persistent cases of asthma of moderate or severe intensity. That explains why the study is stirring interest among those with asthma.

"It's pretty exciting news," said Stephen Gaudet of Crockett, Calif., who does the popular news blog for those with severe asthma, breathinstephen.com. "I'm 58, and I've had asthma since birth. I'm a respiratory therapist by profession, so I know a lot about the disease from both ends. Other than steroids and new inhalers, there hasn't been anything available, especially for people like me with severe disease. If what they are saying about this is true, it's truly ground-breaking stuff."

The drug works to block two different pathways of inflammation that can cause asthma and eczema, among other problems.

In the clinical trial, 52 patients received injections of dupilumab with 52 others receiving a placebo. All were using inhaled steroids and airway-opening drugs known as long-acting beta agonists to control their asthma. All patients in the study also had asthma that features high counts of a white blood cell known as eosinophils that is usually associated with allergies.

For 12 weeks, participants received weekly injections of a placebo or dupilumab. After four weeks, both groups stopped using their long-acting beta agonist. Between the sixth and ninth weeks, they gradually stopped taking the inhaled steroid.

Three patients in the dupilumab group, or nearly 6 percent, had asthma attacks. That compares with 23 people or 44 percent of those receiving the placebo who had asthma attacks.

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David Templeton: dtempleton@post-gazette.com or 412-263-1578


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