Aires Pharmaceuticals Emerges from Stealth Mode With Drug for Pulmonary Arterial Hypertension

11/5/08Follow @xconomy

Aires Pharmaceuticals may have a way to help patients with a rare, deadly lung disease get a little more oxygen, and maybe even live a little longer. The San Diego startup is developing an inhalable form of nitrite that could improve the lives of patients with high blood pressure in the vessels leading to the lungs, known as pulmonary arterial hypertension.

I got the rundown on Aires’ game plan from CEO Wendy Johnson. She found this company’s core technology through her other role as a venture partner with ProQuest Investments. She’s also a 20-year veteran of the San Diego biotech scene, most recently at Salmedix.

Aires has been around a couple years, but has been laying low until it got its cornerstone intellectual property nailed down last month with a license from the National Institutes of Health. The concept is to develop what it calls “Aironite,” a technology which delivers an inhaled nitrite that converts into nitric oxide in a low-acidity or low-oxygen environment in the body. That’s important because the compound can open up tightened blood vessels while also having an anti-inflammatory effect, Johnson says. This sort of treatment could be taken in addition to some other drugs such as Actelion Pharmaceuticals’ bosentan (Tracleer), Pfizer’s sildenafil (Revatio), and Gilead Sciences’ ambrisentan (Letairis). These drugs can extend lives of patients five to seven years, and Aires thinks its medicine can add a couple more years.

“The drugs work, but everyone fails eventually,” Johnson says. “It’s only a matter of time.”

Pulmonary arterial hypertension is a rare disease that affects about two people out of a million in the U.S., says the Pulmonary Hypertension Association. About 16,000 in the U.S. get treatment, according to Aires. Even so, it has grown into a big market since Actelion’s bosentan was the first oral drug approved by the FDA for this disease in 2001. The market is now worth more than $1 billion, Johnson says.

Aires got started a couple years ago with seed capital from Proquest to pursue this idea, and has put about $6 million into the company to date, Johnson says. She’s currently trying to raise another $25 million to bankroll clinical trials. The company has about 10 employees, including Gary Elliott, a former colleague of Johnson’s at Salmedix who is in charge of product development, and Lewis Rubin, acting chief medical officer. Rubin is a leading investigator in pulmonary arterial hypertension who’s taking a leave from a research post at the University of California, San Diego. “He’s seen all of these drugs in trials before,” Johnson says.

Aires feels comfortable talking publicly about its technology now because it has just wrapped up its first clinical trial of its inhaled nitrite, Johnson says. The basic conclusion, from the first 33 patients, is that the drug can be delivered safely, and in high enough concentrations that it should have an effect, Johnson says. The next trial is going to involve 80 volunteers who simulate a low-oxygen environment that patients with this condition experience—sort of like breathing thin air high on a mountainside. The researchers will want to see whether the Aires drug can reverse this state, at different doses, and measure the effect over several hours to see how long it lasts.

These are still very early days for this treatment. The main goal that the FDA has required other drugmakers to achieve is improvement in the distance patients can walk in six minutes. Aires is still trying to figure out whether it needs to give its drug three times a day (not very practical for patients) or whether it can be given once a day, Johnson says. The drug is given through a nebulizer that can fit in a purse or small bag. It takes one or two minutes to administer, she says.

No one else is competing directly with an inhalable drug like this for pulmonary arterial hypertension, although Clinton, NJ-based Ikaria has an inhalable nitric oxide that’s FDA approved for premature infants with “Blue Baby” syndrome. Other companies, like United Therapeutics, Novartis, and Bayer are testing different kinds of medicines, which are further along in development. Johnson isn’t forecasting when her company’s drug might be able to run the gamut of trials needed to reach the marketplace, but when it does, she says it should be able to capture sales that run into the range of “several hundred millions” of dollars.

Johnson has said very little publicly about the company until now, partly because she wanted to make sure she had secured the technology license from the NIH lab of Mark Gladwin, who is now at the University of Pittsburgh Medical Center. “I’m not one of those people who believes you should hype up your company,” Johnson says. “We had to line up some data first in human beings,” she says.

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