LTR Pharma Secures TGA Nod to Launch SPONTAN Phase II Trial for Older Men
LTR Pharma has received regulatory clearance from the Therapeutic Goods Administration to commence its Phase II clinical trial of SPONTAN, focusing on men aged 65 and over. Patient recruitment is set to begin early next year, aiming to address a key gap in erectile dysfunction treatment.
- TGA grants regulatory clearance for SPONTAN Phase II clinical trial
- Study includes a significant cohort of men aged 65+ to assess dosing
- Patient recruitment expected to start in Q1 2026
- Trial to evaluate pharmacokinetics of single and multiple doses
- Focus on improving prescribing insights for older men using PDE5 inhibitors
Regulatory Milestone Achieved
LTR Pharma Limited (ASX, LTP) has reached a pivotal moment in its clinical development journey with the Therapeutic Goods Administration (TGA) granting regulatory clearance for the SPONTAN Phase II clinical study. This clearance follows the recent approval from the Bellberry Human Research Ethics Committee, completing all necessary regulatory steps to initiate the trial in Australia.
Targeting an Underserved Demographic
The Phase II study is designed to evaluate the pharmacokinetics of SPONTAN, an intranasal erectile dysfunction treatment, in approximately 27 healthy male participants. Notably, about half of these participants will be aged 65 years or older, aligning with FDA guidance on geriatric assessments. This focus addresses a significant gap in clinical data for older men, a group often prescribed lower doses of oral PDE5 inhibitors like Viagra and Cialis due to tolerability concerns.
Advancing Patient Recruitment and Clinical Insights
With regulatory clearance secured, LTR Pharma is moving swiftly to activate clinical sites and expects to commence patient recruitment in the first quarter of 2026. The study’s outcomes are anticipated to provide valuable prescribing insights that could influence treatment strategies for older men suffering from erectile dysfunction, potentially improving dosing accuracy and patient outcomes.
Broader Pipeline and Market Potential
SPONTAN is part of LTR Pharma’s broader portfolio of fast-acting intranasal therapies, which includes ROXUS and the investigational OROFLOW for oesophageal motility disorders. The company’s proprietary intranasal delivery platform aims to offer rapid onset treatments that enhance patient convenience and quality of life. Success in this Phase II trial could strengthen LTR Pharma’s position in the competitive erectile dysfunction market, particularly among older patients who have been historically underserved.
Looking Ahead
Executive Chairman Lee Rodne highlighted the significance of this milestone, emphasizing the study’s role in generating clinical data tailored to older men. As LTR Pharma progresses through this trial phase, investors and clinicians alike will be watching closely for data that could reshape prescribing practices and expand treatment options in this demographic.
Bottom Line?
With regulatory hurdles cleared, LTR Pharma is poised to deliver critical clinical insights that could redefine erectile dysfunction treatment for older men.
Questions in the middle?
- How will SPONTAN’s pharmacokinetic profile in older men compare to existing PDE5 inhibitors?
- What are the anticipated timelines for Phase II trial completion and data release?
- Could positive trial outcomes accelerate regulatory approvals in markets beyond Australia?
