Third Pole’s portable inhaled nitric oxide device clears early study

Placebo-controlled safety, efficacy clinical trial expected to launch this year

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by Steve Bryson, PhD |

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Third Pole Therapeutics said it has successfully completed an early feasibility study of its portable inhaled nitric oxide (iNO) delivery device, eNOfit, allowing the company to move to larger trials for pulmonary hypertension (PH) associated with interstitial lung disease.

eNOfit is designed to provide patients with mobile treatment at home or when traveling, without the need to maintain and refill compressed gas cylinders.

The study “validated the safe and practical use of our eNOfit system” and “enables us to confidently move into larger randomized placebo-controlled safety and efficacy studies,” Bill Athenson, CEO of Third Pole, said in a company press release.

“This is a significant milestone for Third Pole and a major step forward in validating the delivery of iNO for home and travel use, to improve the quality of life of the millions of patients suffering from PH due to chronic lung diseases,” Athenson said.

The study was performed under the U.S. Food and Drug Administration’s Investigational Device Exemption, which allowed eNOfit to be used in clinical studies.

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Inhaled nitric oxide relaxes blood vessels, lowering blood pressure

PH is defined as high blood pressure in the pulmonary arteries, which carry blood pumped by the right side of the heart into the lungs to be oxygenated. People with PH experience symptoms such as shortness of breath, fatigue, dizziness, or fainting. Over time, the heart’s right side can fail due to the strain caused by hypertension.

A shortage of oxygen in the body, or hypoxia, is among many potential causes of PH. Chronic hypoxia can stimulate the blood vessels in the lungs to constrict, as well as trigger damaging inflammation that can lead to scarring. All this further increases blood pressure.

Various lung diseases can cause chronic hypoxia associated with PH. These include chronic obstructive pulmonary disease (PH-COPD), a chronic inflammatory disease of the lungs, and interstitial lung disease (PH-ILD), which is marked by scarring in the lungs.

Inhaled nitric oxide, or iNO, is routinely used for PH to help relax and widen blood vessels, thereby lowering blood pressure. The treatment has been shown to reduce the lower resistance of pulmonary blood vessels.

“There is a significant need for new ways to treat patients living with PH-ILD and PH-COPD outside the hospital,” said Rajan Saggar, MD, professor of medicine and director of the pulmonary hypertension program at the David Geffen School of Medicine at the University of California, Los Angeles.

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Lightweight, wearable device can be used along with oxygen

eNOfit works by electrically generating an unlimited supply of iNO directly from the air. The lightweight, wearable device offers pulse dosing and can be used alongside oxygen delivery systems, according to Third Pole’s website. It weighs two pounds, Saggar said.

The company has now successfully tested the device in a clinical setting.

“We look forward to acquiring the clinical data to support the use of eNOfit in at-home and ambulatory settings from Third Pole’s upcoming trials,” Saggar said. “The trials are expected to confirm that the same clinical benefits of nitric oxide in PH observed over the last 30 years in hospitalized patients can be achieved in out-of-hospital patients as well.”

Third Pole in 2017 received a Johnson & Johnson Innovation award for the device, winning the Johnson Innovation JLABS @ M2D2 QuickFire Challenge award. Representatives of companies that win the challenge receive a one-year residency at the University of Massachusetts Medical Device Development Center, along with mentoring and coaching from Johnson & Johnson Innovation specialists.

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