Third Pole Therapeutics Announces First Patient Dosed in Feasibility Study with eNOfit™ Portable Inhaled Nitric Oxide Delivery System
Data from Study Anticipated in Q1 2024
WALTHAM, Mass., Dec. 11, 2023 (GLOBE NEWSWIRE) -- Third Pole Therapeutics, Inc., a privately held company developing critical life-sustaining therapies for people living with cardiopulmonary and infectious diseases, today announced that the first patient has been dosed in an early feasibility study (EFS) performed under an Investigational Device Exemption granted by the FDA. This study is evaluating eNOfit™, a miniaturized, portable inhaled nitric oxide (iNO) generator and delivery system for the ambulatory treatment of patients suffering from pulmonary hypertension (PH) associated with Interstitial Lung Disease (ILD).
“We are excited to bring our eNOfit™ device to the clinic for the first time with the initiation of this study. 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. 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,” said Bill Athenson, CEO of Third Pole.
“There is a significant need for new ways to treat patients living with PH-ILD and PH-COPD outside the hospital. 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", said Dr. Rajan Saggar, Professor of Medicine, Director Pulmonary Hypertension Program, Co-Director Pulmonary Vascular Disease Program, Lung & Heart-Lung Transplant and Pulmonary Hypertension Programs, David Geffen School of Medicine, UCLA.
About Group 3 Pulmonary Hypertension (includes ILD and COPD patients with PH)1,2
In healthy people, deoxygenated venous blood returning to the heart from all body organs and tissues travels from the right heart through the pulmonary arteries into the lungs. Within the lungs, the pulmonary arteries divide into smaller vessels to take in oxygen and remove carbon dioxide in the air sacs (alveoli). The oxygen-rich blood then returns to the left side of the heart from where it is pumped back to body organs and tissues.
Normally, the blood flows relatively easily through the pulmonary arteries, but in PH, the arteries become stiff, damaged, and narrow. This makes blood flow much more difficult and causes the blood pressure in the lungs to rise (PH) and the right heart to work harder. Over time, the right heart can fail, leading to a poor prognosis and death.
Patients with Group 3 PH-ILD suffer from shortness of breath, fatigue, and fainting episodes. They have a difficult time doing normal chores and must take breaks while doing activities of daily living. As their disease advances, they are often dependent on supplemental oxygen to maintain adequate oxygenation levels at rest and on exertion.
1. https://www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-hypertension
About Third Pole Therapeutics
Third Pole Therapeutics develops and delivers critical life-sustaining cardiopulmonary therapies. Warren Zapol, M.D., Third Pole's founder, invented the first use for iNO for the treatment of hypoxic respiratory failure in new-born infants (blue babies). Since then, in addition to blue babies, hundreds of thousands of pediatric and adult patients experiencing elevated pulmonary pressure, inflammation, and poor oxygenation during and after heart surgery have been treated with inhaled nitric oxide, creating a $600 million inhaled NO industry, concentrated in large hospitals and developed markets.
Two decades later, Third Pole has successfully created a scalable technology that generates and delivers NO for inhalation, instantly, on-demand, and in unlimited quantities. Third Pole's technology solves the cost and logistical hurdles which have prevented widespread iNO use in various markets in the U.S. and abroad that lacked the training and infrastructure required to transport, maintain, return, and refill large cylinders of compressed gas safely. Third Pole's two novel platforms include eNOfit™, a miniaturized wearable device for home and travel and eNOcare™, a lightweight portable in-hospital device. Both make NO by combining electricity and ambient air, creating a "make it and take it" therapy, free from the hazards of compressed gas storage. These broadly patented, versatile platforms and derivative products have the potential to rapidly capture the entire existing tank-based market and expand beyond current indications to treat interstitial lung disease (ILD), chronic obstructive pulmonary disease (COPD), cystic fibrosis, heart failure, stroke, and life threatening, refractory viral and bacterial infections. For more information, please visit www.pole3.com.
Third Pole’s product development has been generously supported by awards from the National Heart, Lung, and Blood Institute of the National Institutes of Health and the National Center for Advancing Translational Sciences of the National Institutes of Health.
Third Pole Therapeutics
Elizabeth Holmberg, Chief Financial Officer
908-310-0596
eholmberg@pole3.com
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