Early study of inhaled nitric oxide delivery system doses 1st patient
Third Pole is testing eNOfit for feasibility in PH patients with lung disease
An early feasibility study evaluating Third Pole Therapeutics‘ eNOfit — a miniaturized, portable inhaled nitric oxide (iNO) delivery system to treat pulmonary hypertension (PH) associated with interstitial lung disease — has dosed its first patient, the company announced.
The goal for the investigational device is to provide patients mobile therapy at home or when traveling, without the need to maintain, return, and refill large cylinders of compressed gas safely.
Data from the study — given the go-ahead by the U.S. Food and Drug Administration under the Investigational Device Exemption, which allowed the device to be used in patients — is expected by March 2024. Favorable safety and efficacy data from the feasibility study aims to support a placebo-controlled trial planned for next year.
“We are excited to bring our eNOfit device to the clinic for the first time with the initiation of this study,” Bill Athenson, CEO of Third Pole, said in a company press release.
“We have designed this study to validate the safe and practical use of our eNOfit system prior to moving into a larger randomized placebo-controlled safety and efficacy study in 2024,” Athenson said.
eNOfit device would provide mobile therapy at home or when traveling
In people with pulmonary hypertension, high blood pressure in the vessels, called the pulmonary arteries, that carry blood through the lungs leads to various PH symptoms, such as shortness of breath, dizziness or fainting, and fatigue. Some cases of PH are caused by interstitial lung disease, or PH-ILD, which is characterized by scarring and inflammation that damage the lungs.
Inhaled nitric oxide, known as iNO, is a vasodilator gas that is used as a routine treatment for PH. It works by relaxing and widening blood vessels and lowering blood pressure.
The eNOfit is a lightweight, wearable device that electrically generates an unlimited supply of iNO directly from air. The device provides pulse dosing and is compatible with oxygen delivery systems, according to Third Pole’s website.
Third Pole has been developing eNOfit to provide new options for PH patients — especially for use at or away from home.
There is a significant need for new ways to treat patients living with PH-ILD and PH-COPD outside the hospital.
eNOfit also is expected to be used in people with PH associated with chronic obstructive pulmonary disease (PH-COPD), a chronic inflammatory disease of the lungs.
“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.
“We look forward to seeing the emerging clinical data supporting eNOfit in at-home and ambulatory settings from these trials, which should confirm the clinical benefits of nitric oxide on PH observed over the last 30 years in hospitalized patients,” Saggar said.
In 2017, Third Pole won a Johnson & Johnson Innovation award for the iNO-generating device. That award provided a year’s residency at the University of Massachusetts Medical Device Development Center. It also provided the company with mentors and coaching from Johnson & Johnson Innovation specialists.
Now, the company is testing its device for the first time in a clinical setting.
“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 like ILD and COPD,” Athenson said.