Glaxo Studies Three-In-One Emphysema Medicine to Keep Lead

GlaxoSmithKline Plc, maker of Advair, the world’s best-selling drug for smoker’s cough and asthma, is considering a three-in-one treatment delivered in a single device to stay ahead of competitors such as Novartis AG.

Glaxo is exploring the next steps for its experimental GSK961081 drug, which combines two different types of treatments that help open up the airways in a single molecule for patients who have emphysema or chronic bronchitis from smoking, said Darrell Baker, head of the company’s respiratory drug development. The double-duty molecule may allow Glaxo to develop a triple-therapy for hard-to-treat patients delivered through a single device, which has not yet been done.

The new formulation would differentiate Glaxo from competitors, particularly Novartis, with which it is currently racing to commercialize a once-daily treatment for smoker’s cough, said Daniel Mahony, a health-care fund manager at Polar Capital LLP in London.

“Novartis is trying to stamp into the field,” he said. “This is Glaxo’s way of flexing their muscles.”

Glaxo is developing new treatments to replace its aging best-seller, Advair, which had global sales of $8 billion last year. Patients taking 400 micrograms of GSK961081, also known as MABA, once a day were able to expel 215 milliliters (7.3 ounces) more air from their lungs in one second than those receiving a placebo after 29 days of treatment, according to a mid-stage study presented today at the European Respiratory Society’s annual meeting in Vienna.

Quickest Route?

Triple-therapy would mix an inhaled corticosteroid, or ICS, which reduces inflammation, with MABA, whose two compounds help open up the airways. Currently 25 percent to 30 percent of patients with smoker’s cough receiving treatment are already combining the three agents using two inhalers, Baker said.

“MABA may be the quickest route to triple-therapy,” Glaxo’s Baker said in an interview in Vienna yesterday. “If you can have a product like the MABA, which is one molecule with two modes of action, then you reduce the level of complexity down to the level of complexity of a dual formulation like Advair.”

MABA may enter late-stage trials soon and reach the market in 2016, Gbola Amusa, an analyst at UBS AG, wrote in a note to investors today. AstraZeneca Plc has just begun mid-stage testing on a rival product, he added.

“MABA could be a defining asset,” Amusa said.

Glaxo is now in talks with partner Theravance Inc. about further clinical studies on MABA, Baker said, declining to outline a timeline for the trials.

“That’s the strategic discussion we’re having right now: what is the right ICS and how do we go forward with the MABA,” Baker said.

Inhaler Device

The triple therapy is also possible because Glaxo has already developed a new Ellipta inhaler device, which has two strips for delivering two compounds, unlike the single strip in the Advair Diskus.

“So you only mix the medicines at the point of inhalation,” Baker said. “That greatly simplifies the development.”

While Novartis is also looking at triple-therapy, there are “a lot of technical formulation issues” that make it challenging, said David Morris, Novartis’s head of development for primary care, which includes respiratory disease.

For new asthma treatments, Glaxo is interested in the possibility of targeting protein molecules such as Toll receptors that can change the innate immune reaction that people have to allergens and other triggers, Baker said.

“If you can modulate that, you may actually be able to turn off the asthmatic tendency,” he said. “But this is very early discovery work.”

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