Third Pole Therapeutics announced today the successful completion of an early feasibility study (EFS) performed under an Investigational Device Exemption granted by the FDA.
WALTHAM, Mass., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Third Pole Therapeutics, a privately held company developing critical life-sustaining therapies for people living with cardiopulmonary and infectious diseases, announced today the successful completion of an early feasibility study (EFS) performed under an Investigational Device Exemption granted by the FDA. This study evaluated 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).
“The successful completion of our EFS which validated the safe and practical use of our eNOfit™ system, enables us to confidently move into larger randomized placebo-controlled safety and efficacy studies. 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. Importantly, this value creating milestone will trigger the final funding of Third Pole’s Series B investment round.” said Bill Athenson, CEO of Third Pole.
“In addition to Third Pole’s eNOcare™ device, in development to increase access and affordability of nitric oxide for in hospital use, the eNOfit™ device is a two-pound, portable NO generation and delivery device for outpatient use. 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 acquiring the clinical data to support the use of eNOfit™ in at-home and ambulatory settings from Third Pole’s upcoming trials. 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”, 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.
The Group 3 Pulmonary Hypertension cohort includes ILD and COPD patients with PH 1,2. In healthy people, deoxygenated blood returning to the heart from all organs and tissues is pumped by 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, where it is pumped back to organs and tissues. Normally, the blood flows 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. Inhaled nitric oxide relaxes smooth muscle within the pulmonary vasculature, increasing the diameter of pulmonary arteries and decreasing their resistance to blood flow. Inhaled nitric oxide has been shown in the clinic to reduce the load on the right heart but this benefit has yet to be demonstrated in patients outside the hospital.
- https://www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-hypertension
- https://pulmonaryhypertensionrn.com/functional-classification-of-pulmonary-arterial-hypertension-pah/
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 persistent pulmonary hypertension 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 iNO 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.
Last year, Third Pole announced an agreement for a $32M strategic equity investment to accelerate the development of its tankless iNO platform from one of the largest healthcare companies in the world to enhance their product offering in the cardiopulmonary device market. Third Pole was chosen as “best in class” technology that will solve 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 innovative 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.
Contact:
Third Pole Therapeutics
Elizabeth Holmberg, Chief Financial Officer
908-310-0596
eholmberg@pole3.com
