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Trial to Explore Microbiome Therapy for Hypertension

Blood pressure measurement


16 December 2016. A clinical trial is set to begin that tests live bacteria as a treatment for hypertension, or high blood pressure, a condition affecting 1 in 3 adults in the U.S. Biotechnology enterprise AOBiome LLC in Cambridge, Massachusetts is conducting the trial after unexpected results in a separate clinical study showed a possible link between the company’s ammonia oxidizing bacteria and blood pressure.

According to Centers for Disease Control and Prevention, some 75 million people in the U.S., about one-third of all adults, have high blood pressure, of which only about half (54%) have their conditions under control. High blood pressure rarely has symptoms, but increases the risk of stroke and heart disease, two of the leading causes of death in the U.S.

AOBiome develops skin care cosmetics and treatments seeking to reintroduce bacteria that oxidize ammonia eliminated from the skin microbiome through modern hygienic practices. Ammonia-oxidizing bacteria, says the company, convert ammonia and urea from perspiration to nitrite and nitric oxide. Nitrite helps control the growth of other microbes, including pathogens, while nitric oxide is a signaling molecule that helps regulate inflammation.

The company’s lead therapeutic candidate, code-named B244, is a topical spray that applies ammonia-oxidizing bacteria to the skin thus restoring the natural microbial balance controlling skin inflammations such as acne. In an early clinical trial testing B244 in people with acne, one of the study’s safety indicators was blood pressure changes in participants.

The study team found a high correlation between the dose of B244 received in the facial spray and blood pressure of participants with normal blood pressure. The effect, says the company, was strong enough to reach statistically reliable levels at the highest dose. AOBiome adds that since it discovered this effect, the company engaged experts on blood pressure to verify a possible mechanism linking ammonia oxidizing bacteria on the vascular system.

“We have long postulated that delivering nitric oxide in host mediated environment would regulate blood pressure,” says Joel Neutel, a hypertension specialist in an AOBiome statement, “but until the discovery of this bacteria, this has proven to be extremely difficult to achieve.” Neutel adds that the link between nitric oxide and blood pressure, “potentially provides us with a new modality of treatment for patients with pre-hypertension and the ability to improve blood pressure control in hypertensive patients without adversely impacting patient lives.”

AOBiome is partnering with contract research company Veristat for an intermediate-stage clinical study testing B244 as a treatment for hypertension against a placebo. The trial expects to enroll 116 participants with hypertension in a 28-day study.

As reported in Science & Enterprise, AOBiome is a 3 year-old company, whose founders include David Whitlock, an MIT-trained chemical engineer, who told the Boston Globe last year he hasn’t showed since the year 2000. Whitlock instead prefers to maintain microbial balance on his skin with the company’s consumer skin care products, marketed under the brand name Mother Dirt.

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