OROFLOW Clinical Study Receives Ethics Approval
Released
Released
Announcement PDF
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LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
OROFLOW®
Clinical Study Receives Ethics Approval, Expanding
LTR Pharma’s Intranasal Platform into Gastrointestinal Disease
24 June 2026
Highlights
• OROFLOW®
becomes the first gastrointestinal application of LTR Pharma's proprietary intranasal platform
to enter formal clinical evaluation.
• Human Research Ethics Committee (HREC) approval received for investigator-initiated clinical study
following encouraging early clinical observations.
• Study builds on preliminary clinical experience suggesting potential improvements in swallowing function
and eating-related chest pain in patients with Oesophageal Motility Disorders (OMD), a global market
projected to reach approximately US$8.1 billion by 2034¹.
• Study to be independently led by Dr Peter Wu, Director of St George Motility Services.
• OROFLOW®
is designed as a non-invasive alternative to current invasive OMD procedures, including
surgery, pneumatic dilation and botulinum toxin injection.
LTR Pharma Limited (ASX:LTP) (“LTR Pharma” or “the Company”) is pleased to announce that the South Eastern
Sydney Local Health District Human Research Ethics Committee (HREC) has approved an investigator-initiated
clinical study evaluating OROFLOW®
in patients with Oesophageal Motility Disorders (OMD). The study will be
independently led by Dr Peter Wu, Director of St George Motility Services at St George Hospital. The study follows
preliminary clinical observations by Dr Wu suggesting that intranasal PDE5 inhibitor therapy may improve
swallowing function and reduce eating-related chest pain in patients with oesophageal motility disorders.
PDE5 inhibitors have been investigated in oesophageal motility disorders for their ability to relax smooth muscle
and reduce lower oesophageal sphincter pressure. This may render the oesophagus more distensible, allowing
swallowed food to pass and empty more effectively. The anticipated clinical benefit is improved oesophageal
emptying and a reduction in dysphagia (difficulty swallowing) and chest pain during eating, potentially helping
patients return to more normal eating patterns and daily activities.
As a non-invasive intranasal spray, OROFLOW may be particularly suited to patients with swallowing difficulties,
removing the need to take an oral tablet while offering a rapid route of administration.
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LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
Study Design
The PILOT study will be conducted in two stages. It will first assess the time course of OROFLOW's effect in healthy
volunteers before progressing to patients with OMD. Investigators will evaluate effects on oesophageal
contractility, bolus flow timing and bolus distension pressure.
The study population includes individuals diagnosed with achalasia, oesophageal outflow obstruction, diffuse
oesophageal spasm and oesophageal hypercontractility who are scheduled to undergo Peroral Endoscopic
Myotomy (POEM).
The Company expects study initiation in the coming quarter and will provide updates on recruiting progress and
data availability as milestones are achieved.
Dr Peter Wu said:
"Patients with achalasia and related motility disorders often face a difficult choice between living with debilitating
symptoms and undergoing invasive procedures such as surgery or repeated dilation. In my practice, I have treated
several achalasia patients with this intranasal approach and observed meaningful improvements in their ability
to swallow, along with a reduction in chest pain during eating. These early observations are encouraging, but they
need to be tested rigorously, which is the purpose of the PILOT study. If we can confirm a measurable effect on
oesophageal function, a fast-acting and non-invasive treatment could change how these patients are managed,
potentially reducing or delaying the need for surgery."
Strategic Significance
The study represents the first formal clinical evaluation of LTR Pharma’s proprietary intranasal platform outside
erectile dysfunction and is expected to provide important proof-of-concept data regarding the broad applicability
of the platform. Success could support the development of additional intranasal therapies beyond erectile
dysfunction and further expand the commercial potential of the platform. OMD remains an area of significant
unmet need, with many patients ultimately requiring invasive interventions including surgery, pneumatic dilation
or botulinum toxin injection. The global OMD treatment market was estimated at approximately US$4.5 billion in
2024 and is projected to reach US$8.1 billion by 2034.¹ Further updates, including study timelines, will be provided
as the program progresses.
The study is funded by a research grant from LTR Pharma, administered through the South Eastern Sydney Local
Health District. As an investigator-initiated study, it is designed, led and conducted independently by Dr Wu and
his team, with no payments made to the investigators beyond their usual salaries.
LTR Pharma Executive Chairman, Lee Rodne, said:
"OROFLOW represents an exciting opportunity to apply the same rapid-acting intranasal delivery technology
underpinning SPONTAN and ROXUS to a completely new therapeutic area. The decision by a leading motility
specialist to independently evaluate this approach reflects growing clinical interest in the broader potential of our
1800 519 711 | ltrpharma.com | investors@ltrpharma.com
LTR Pharma Limited (ABN 64 644 924 569 / ACN 644 924 569)
platform. We are pleased to support research that could ultimately provide patients with a fast-acting, non-
invasive alternative to existing treatment approaches.”
About Oesophageal Motility Disorders
Oesophageal motility disorders are conditions characterised by abnormal movement and coordination of the
oesophagus, leading to impaired swallowing and painful oesophageal contractions. Subtypes include achalasia,
oesophageal outflow obstruction, diffuse oesophageal spasm and hypercontractile oesophagus.
- ENDS -
This announcement has been approved by the Board of Directors.
¹ Fact.MR. "Ineffective Oesophageal Motility Treatment Market Analysis | 2034." Fact.MR, 2024.
About LTR Pharma
LTR Pharma is a commercial-stage pharmaceutical company delivering innovative therapies to address significant
unmet medical needs through its proprietary intranasal drug-delivery platform. The Company has successfully
commercialised its rapid-acting treatment technology in Australia and is expanding access whilst advancing
regulatory pathways in the US and other key markets.
LTR’s lead products, SPONTAN®
and ROXUS®
, are fast-acting intranasal sprays for the treatment of erectile
dysfunction, enabling onset of action in 10 minutes or less. Building on this proven technology, the Company is
now advancing OROFLOW®
, a novel intranasal spray under development for the treatment of Oesophageal
Motility Disorders (OMD) – a debilitating group of conditions affecting swallowing function.
Through strategic partnerships, LTR Pharma is expanding its pipeline and global footprint to deliver differentiated,
patient-centric treatments that enhance quality of life.
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