Third Pole Therapeutics has dosed the first patient in an early feasibility trial investigating its portable inhaled nitric oxide delivery system.
The early feasibility study is evaluating the safety and tolerability of Third Pole’s device, dubbed eNOfit, in patients with pulmonary hypertension accompanying interstitial lung disease (PH-ILD).
The device’s use was under an investigational device exemption granted by the US Food and Drug Administration (FDA).
Data from the multi-centre study (NCT05867914) is expected in Q1 2024, according to US-based Third Pole.
eNOfit is a miniaturised portable nitric oxide generator and delivery system for ambulatory treatment of patients living with the disease, which is characterised by higher blood pressure in the lungs. Patients with PH-ILD have shortness of breath, fatigue, fainting episodes, and reduced exercise capacity according to Third Pole.
Third Pole’s wearable device makes nitric oxide by combining electricity and air. Inhaled nitric oxide is a recommended therapy for various hypertension conditions. The gas is a vasodilator, meaning it can help alleviate high pressure in blood vessels.
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Third Pole has another product, called eNOcare, for use as an in-hospital device. According to the company, the inhaled nitric oxide global market is worth $600m.
Third Pole’s trial is estimated to enrol five participants. All subjects will receive inhaled nitric oxide at doses of 2mg/h and 6mg/h for just over two hours at each device setting, totalling four and a half hours of treatment time.
The validation of the device’s safety and practical use will go towards the planning of a larger, randomised placebo-controlled safety and efficacy study, according to Third Pole’s CEO Bill Athenson. This is planned to begin in 2024.
In December 2022, Third Pole secured $32m in Series B financing. This added to the $25m raised through venture financing in January 2022.
Athenson added: “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.”
This year has been a tricky year for nitric oxide devices, after high-profile class I FDA recalls. NOxBOX recalled 767 of its devices in July due to a valve misalignment while Mallinckrodt Manufacturing recalled 1,799 boxes of its valves used in its INOmax delivery system in September.