LTR Pharma has received ethics approval for a clinical study of SPONTAN® in pulmonary arterial hypertension (PAH). PAH represents a significant global therapeutics market, estimated at US$8.0 billion in 2024 and forecast by third-party sources to reach up to US$17.9 billion by 2034.
What is pulmonary arterial hypertension (PAH)?
PAH is a serious, progressive and currently incurable disease. The arteries from the heart to the lungs narrow, increasing resistance to blood flow and strain on the right side of the heart. Symptoms can include shortness of breath, fatigue, reduced exercise capacity, chest pain, palpitations, dizziness and fainting, with advanced disease potentially leading to right-heart failure.
PDE5 inhibitors like sildenafil are established treatments for PAH. Taken orally, sildenafil typically takes around 30 minutes to two hours to peak in the blood. SPONTAN is our intranasal formulation of vardenafil, another PDE5 inhibitor, and has shown rapid absorption in healthy volunteers (peak blood levels around 10 minutes). This study will test whether a single intranasal dose of SPONTAN can reduce pulmonary vascular resistance (the resistance to blood flow through the lungs) within 15 minutes in newly diagnosed, untreated patients. The study is expected to commence in the quarter ending 31 December 2026.
Professor David Celermajer, Head of Cardiology at Royal Prince Alfred Hospital, Scandrett Professor of Cardiology at the University of Sydney and Clinical Director of the Heart Research Institute, will independently lead the study.
LTR Pharma Executive Chairman, Lee Rodne: “This study represents another important opportunity to evaluate LTR Pharma’s intranasal platform in a serious disease with significant unmet need and a large global market. PDE5 inhibition is already an established treatment approach in PAH. The opportunity we are exploring is whether SPONTAN can produce a rapid, measurable haemodynamic effect within minutes of administration.
Importantly, this investigator-initiated study is being independently led by Professor Celermajer and provides an efficient pathway to generate early clinical data in another potentially valuable therapeutic application. Together with OROFLOW, it further demonstrates the broader potential of our intranasal platform beyond erectile dysfunction.”