Ethics approval clears SPONTAN for pulmonary arterial hypertension study
LTR Pharma (ASX: LTP) has received ethics approval from the Bellberry Human Research Ethics Committee (HREC) for an investigator-initiated clinical study evaluating SPONTAN® in patients with newly diagnosed and untreated pulmonary arterial hypertension (PAH).
The study will be independently designed, led and conducted by Professor David Celermajer, Head of the Department of Cardiology at Royal Prince Alfred Hospital. It is expected to commence in the quarter ending 31 December 2026.
The study is a further clinical evaluation of LTR’s intranasal platform beyond erectile dysfunction. Key points from the announcement include:
- Ethics approval received from the Bellberry HREC
- Study independently led by Professor Celermajer
- Haemodynamic effects to be assessed 15 minutes after administration
- Funded through an LTR Pharma research grant administered by the Sydney Local Health District
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What the study will test
Study design
The study will evaluate whether a single intranasal dose of SPONTAN can rapidly reduce pulmonary vascular resistance (PVR) in newly diagnosed, untreated PAH patients. PVR is a measure of how much resistance blood meets as it flows through the lungs.
Haemodynamic effects, meaning the effects on blood flow, will be assessed 15 minutes after administration, together with safety and tolerability.
Funding and independence
The study is funded through an LTR Pharma research grant administered by the Sydney Local Health District. As an investigator-initiated study, it is designed, led and conducted independently by Professor Celermajer and his team.
Professor David Celermajer
“…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.”
PDE5 inhibition and why speed matters
PAH is a rare, progressive and currently incurable disease. 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.
Symptoms can include:
- Shortness of breath
- Fatigue
- Chest pain
- Dizziness
- Fainting
PDE5 inhibitors, including sildenafil and tadalafil, are established PAH therapies. 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 administration.
The final Phase II Clinical Study Report found SPONTAN 5 mg reached peak blood concentration in a median of 10 minutes, against 60 minutes for the 20 mg oral vardenafil tablet, which is the pharmacokinetic basis for testing a 15-minute haemodynamic effect in PAH.
The study will explore whether that rapid systemic exposure can translate into a measurable haemodynamic effect within 15 minutes. This is a hypothesis under test, and the announcement describes the outcome as early clinical data on SPONTAN’s potential as a differentiated treatment approach.
Market opportunity and platform strategy
A large therapeutics market
The announcement cites two third-party estimates of the PAH therapeutics market. They use different bases and scopes, so they are shown separately below.
| Source | Base figure | Forecast | Period/scope |
|---|---|---|---|
| Grand View Research | US$8.0 billion (2024) | US$13.3 billion by 2033 | Global market, 5.9% annual growth |
| GlobalData | US$10.1 billion (2024) | US$17.9 billion by 2034 | Sales across 68 markets |
These are third-party estimates and are not forecasts of LTR Pharma revenue.
Building on OROFLOW
The PAH study follows the OROFLOW® study in oesophageal motility disorders announced in June 2026. According to the company, the two studies demonstrate the expanding clinical potential of its intranasal platform across multiple therapeutic areas.
Lee Rodne, Executive Chairman
“…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…”
The company states that positive results could provide a foundation for LTR Pharma to evaluate further clinical development and commercial opportunities. The announcement does not state any timeline or revenue outcome.
What to watch next
The study is expected to commence in the quarter ending 31 December 2026, and LTR Pharma has said it will provide further updates as material milestones are achieved.
The announcement does not disclose results, enrolment numbers or completion dates. LTR Pharma describes itself as a commercial-stage company that has commercialised its rapid-acting treatment technology in Australia and is advancing regulatory pathways in the US and other key markets. SPONTAN and ROXUS® are intranasal sprays for erectile dysfunction with onset of action in 10 minutes or less.
Real-world use is already building in the core indication, with more than 2,000 bottles dispensed in Australia under the TGA Special Access Scheme, though the company has disclosed no revenue figures from that activity.
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