VentiRx, With Venti-Sized Ambition to Treat (and Maybe Prevent) Allergies, Passes First Big Test

10/7/10Follow @xconomy

Every corner drugstore carries cheap meds for allergies, and about 30 million people in the U.S. still suffer from the symptoms. But now VentiRx Pharmaceuticals, a small biotech with operations in Seattle and San Diego, has generated some intriguing data that suggests it might have found a completely new way to treat—and possibly prevent—allergies.

VentiRx is announcing today that its lead drug candidate for nasal allergies was able to help relieve the stuffy nose, runny nose, sneezing, and itchy eyes commonly found in allergy sufferers, in a clinical trial of 80 patients, during allergy season, who were exposed to allergens in a scientifically controlled environment. The VentiRx drug, designed to be the first once-weekly nasal spray for allergies, showed a statistically significant improvement at both a low and high dose, when compared to patients who got a placebo. Detailed results will be presented at an upcoming medical meeting, the company says.

There’s some intriguing science underpinning this finding that makes today’s finding especially interesting. While there are lots of different options for treating allergies—antihistamine pills, corticosteroids as nasal sprays—VentiRx is trying to pull off a novel biological trick by stimulating something called the TLR8 receptor of the innate immune system. This idea seeks to exploit the growing scientific literature on the “hygiene hypothesis,” which essentially says that people in super-sanitized places like the U.S. and Europe have higher rates of allergies because our immune systems aren’t exposed to many pathogens when we are young, and so our immune systems overreact as adults when we are confronted with everyday allergens. Through careful stimulation of TLR8, a first-line defense mechanism of the immune system, VentiRx is seeking to create a diversion of sorts, that basically distracts the immune system so it doesn’t go wild when encountering everyday pollens, grass, or dust.

“We have shown clear clinical activity for this drug,” says Rob Hershberg, VentiRx’s co-founder and executive vice president of R&D.

Rob Hershberg

Rob Hershberg

By stimulating the TLR8 receptor of the immune system in a generalized sense, VentiRx is hopeful that this drug could be helpful for people with a wide variety of different kinds of allergies to ragweed, pollens, or various other allergens, Hershberg says. It’s the first potential drug that can be made into a once-weekly nasal spray, compared with other sprays on the market today that are taken once or twice a day. And further in the future, VentiRx is planning to see if the product can be turned into a preventive medicine for people who want to brace themselves in advance for seasonal allergies or even year-round symptoms.

All of that is still on the drawing board for now. VentiRx raised $25 million in venture capital back in January from MedImmune Ventures, Arch Venture Partners, Frazier Healthcare Ventures, and Domain Associates, but that’s really just a small down payment for the development plan to come. The company is also developing a cancer drug, but that’s another  story for another day.

For now, VentiRx is thinking  about much bigger clinical trials it will need to run  for treating allergies. So VentiRx is now having some advanced talks with potential partners with the money and manpower to run a global clinical trial plan, with the big numbers of patients required to win approval from the FDA and other regulatory agencies around the world.

“The product profile that’s emerging is a unique one. Our attitude is that this is a compound that should be developed across the globe, against a variety of allergens,” says Mike Kamdar, the company’s other co-founder, and executive vice president of business development.

Allergies of the nose, called allergic rhinitis in medical terms, represent a $5 billion potential market alone, Kamdar says. Some of the widely used allergy meds on the market today have either already lost patent protection or soon will face competition from cheaper generics, which Kamdar says should create an opening for a novel once-weekly nasal spray that should work against a lot of different kinds of allergies.

The path to FDA approval has been traveled many times by other pharma companies, and VentiRx used the same standard clinical trial goal (Total Nasal Symptom Scores) that the FDA has used to assess allergy drugs of the past. And the VentiRx drug is a conventional small-molecule chemical, not a protein drug, meaning it should be cheap and easy to manufacture as a mass-marketed product for millions of people.

“We can see a clear path to [FDA] registration as a therapeutic, and see a good size opportunity,” Kamdar says.

Of course, this being VentiRx, Hershberg had to slip in a little joke at the end of the interview about the company name. Hershberg, a Seattleite to the core, loves to remind people that the company name was inspired by the biggest coffee drink sold by Starbucks, the 20-ounce venti. The company called itself VentiRx, he once said, because “it’s going to be big.”

This time, he acknowledged that while VentiRx has generated some potentially big data, it has some Venti-sized work ahead. “We’ll have a few ventis around here and move this forward,” he said.

I asked him to clarify whether he meant venti-sized coffee, or maybe a venti-sized beer to celebrate passing the Phase I trial? He didn’t hesitate in answering that one.

“We’re going to have to have a few more venti coffees,” Hershberg says. “The venti ales will have to wait until after FDA approval.”

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