LTR Pharma (ASX:LTP) has secured ethics approval for the next stage of clinical development of its fast-acting erectile dysfunction therapy, paving the way for recruitment to begin early next year and marking another step in the company’s expansion into global markets.
The approval, granted by Bellberry Human Research Ethics Committee, clears the SPONTAN Phase 2 pharmacokinetic and multiple-dose study to proceed. The trial will be conducted at Scientia Clinical Research in Sydney and is designed in line with FDA Pre-IND guidance to examine both single- and multiple-dose use of the intranasal therapy.
The study will recruit around 27 healthy male participants across three cohorts, with approximately half aged 65 or older. This focus on older men reflects FDA geriatric-use requirements and aims to generate prescribing information for the group that is routinely prescribed lower doses of oral PDE5 inhibitors such as Viagra.
Participants will take part in a 15-day residential program receiving SPONTAN in both single and multiple doses, alongside a comparator vardenafil tablet. Pharmacokinetic analyses will be performed by Resolian Bioanalytics, with Southern Star Research serving as CRO. Initial results are expected in the second quarter of 2026, with full findings due mid-year.
A Clinical Trial Notification will now be filed with the Therapeutic Goods Administration, marking a key progression in LTR Pharma’s FDA 505(b)(2) regulatory pathway. The company’s earlier Phase I study showed SPONTAN achieved 470 per cent faster absorption than oral tablets.
LTR Pharma Executive Chairman Lee Rodne said the ethics approval represented a significant step in the company’s clinical and commercial roadmap.
“Securing ethics approval allows us to commence a targeted Phase II study expressly designed to meet FDA expectations for multiple-dose pharmacokinetics and geriatric representation. Importantly, this study will generate valuable data to help physicians make informed prescribing decisions for men aged 65 and older, who often receive reduced-dose oral PDE5 therapies. With ROXUS on track for US market entry in the first half of 2026 and SPONTAN progressing through clinical development, we continue to execute our multi-market commercial strategy.”
The company says SPONTAN is part of a broader intranasal drug-delivery platform designed to provide rapid-acting treatments for significant unmet needs. Its commercialised technology already underpins ROXUS, which is preparing for US entry, while the pipeline also includes OROFLOW, a new intranasal therapy for oesophageal motility disorders.