Ethics Approval Clears Path for SPONTAN Study Amid Geriatric Dosing Challenges
LTR Pharma has secured ethics approval for its Phase II SPONTAN clinical trial, focusing on pharmacokinetics and dosing in men aged 65 and older. Recruitment begins early 2026 with initial results expected mid-year.
- Ethics approval granted for SPONTAN Phase II clinical study
- Study includes approximately 50% participants aged 65+, addressing FDA geriatric guidelines
- Randomised cross-over design comparing SPONTAN with oral vardenafil
- Recruitment to start in Q1 2026, initial data expected Q2 2026
- Supports FDA 505(b)(2) regulatory pathway and future prescribing guidance
Ethics Approval Unlocks Next Phase
LTR Pharma Limited (ASX, LTP) has reached a pivotal milestone with ethics approval from Bellberry, an independent committee certified by Australia's National Health and Medical Research Council, for its Phase II clinical trial of SPONTAN. This approval clears the way for patient recruitment to begin in early 2026, marking a significant step forward in the company’s clinical development program.
Targeting an Underserved Population
The study is designed with a keen focus on men aged 65 and older, a demographic often underrepresented in clinical trials yet frequently prescribed lower doses of oral PDE5 inhibitors like Viagra due to tolerability and pharmacokinetic concerns. Approximately half of the 27 healthy male participants will be from this geriatric cohort, aligning with FDA guidance to better understand drug behavior in older patients.
Study Design and Objectives
This randomised cross-over trial will be conducted at Scientia Clinical Research in Sydney, where participants will undergo a 15-day residential period receiving both single and multiple doses of SPONTAN alongside a control vardenafil tablet. Southern Star Research has been appointed as the Clinical Research Organisation, with Resolian Bioanalytics handling pharmacokinetic blood sample analysis. The study aims to characterize how SPONTAN is absorbed and processed in the body over multiple doses, providing critical data to inform prescribing practices.
Regulatory Significance
The Phase II trial is a cornerstone in LTR Pharma’s FDA 505(b)(2) regulatory pathway, building on promising Phase I results that showed SPONTAN’s absorption was 470% faster than oral tablets. The inclusion of a robust geriatric cohort is expected to strengthen future submissions to both the FDA and Australia’s Therapeutic Goods Administration, potentially influencing dosing recommendations for older men with erectile dysfunction.
Looking Ahead
Initial data from the study is anticipated in the second quarter of 2026, with full results expected by mid-year. This timeline dovetails with LTR Pharma’s broader commercial strategy, which includes the upcoming US market entry of ROXUS, another intranasal therapy, in the first half of 2026. Together, these developments underscore LTR Pharma’s commitment to expanding access to rapid-acting, patient-centric treatments.
Bottom Line?
With ethics approval secured, LTR Pharma is poised to deliver critical clinical insights that could reshape erectile dysfunction treatment for older men.
Questions in the middle?
- How will SPONTAN’s pharmacokinetic profile in older men compare to existing oral PDE5 inhibitors?
- What impact will Phase II results have on FDA and TGA prescribing guidelines for geriatric patients?
- How might these clinical outcomes influence LTR Pharma’s competitive positioning ahead of ROXUS’s US launch?