- Ethics approval received for an investigator-initiated clinical study evaluating SPONTAN in PAH
- PAH represents a significant global therapeutics market, estimated at US$8 billion in 2024
- The study will evaluate whether SPONTAN can produce a measurable haemodynamic effect within 15 minutes
- Study represents a further clinical evaluation of LTR’s intranasal platform beyond erectile dysfunction
LTR Pharma (ASX: LTP) has received approval from the Bellberry Human Research Ethics Committee (HREC) of an investigator-initiated clinical study evaluating SPONTAN in patients with newly diagnosed and untreated Pulmonary Arterial Hypertension (PAH).
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The study will be independently designed, led and conducted by Professor David Celermajer, head of the Department of Cardiology at Royal Prince Alfred Hospital, Scandrett professor of Cardiology at the University of Sydney and clinical director of the Heart Research Institute.
PAH is a serious, progressive and currently incurable disease in which narrowing of the pulmonary arteries increases resistance to blood flow and places increasing strain on the right side of the heart, potentially leading to right-heart failure. Despite advances in treatment, there remains a need for differentiated therapeutic approaches.
PDE5 inhibitors, including sildenafil and tadalafil, are established PAH therapies. However, oral administration requires gastrointestinal absorption before reaching systemic circulation, with peak blood concentrations typically occurring approximately 30 minutes to two hours after dosing.
SPONTAN is LTR Pharma’s intranasal formulation of vardenafil, another PDE5 inhibitor.
Previous pharmacokinetic studies have demonstrated rapid absorption following SPONTAN’s administration. The PAH study will explore whether SPONTAN’s rapid systemic exposure can translate into a measurable haemodynamic effect within 15 minutes, providing early clinical data on its potential as a differentiated treatment approach in PAH.
“Oral PDE5 inhibitors are an established part of PAH treatment. This study will directly measure whether intranasal SPONTAN can rapidly reduce pulmonary vascular resistance in newly diagnosed, untreated patients. The controlled haemodynamic assessment will provide important early clinical data on the potential of SPONTAN in PAH,” Professor Celermajer said.
The PAH study represents a further evaluation of LTR Pharma’s rapid-acting intranasal platform beyond erectile dysfunction and follows the OROFLOW study in oesophageal motility disorders announced in June 2026. Together, these studies demonstrate the expanding clinical potential of LTR’s intranasal platform across multiple therapeutic areas where rapid systemic exposure may offer meaningful clinical differentiation.
The study is expected to generate early clinical data on SPONTAN’s potential in PAH. Positive results could provide a foundation for LTR Pharma to evaluate further clinical development and commercial opportunities in this significant therapeutic market.
LTP was down 1.03% to 48.0¢. Mkt cap $88.16M.
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