LTR Pharma (ASX:LTP) has completed recruitment for its Phase 2 pharmacokinetic clinical study of SPONTAN, a novel intranasal spray designed to provide rapid-acting treatment for erectile dysfunction.
The study marks a critical step in the company’s regulatory journey, with all 27 participants now successfully enrolled across three distinct cohorts.
The final cohort of eight participants is currently undergoing a 15-day residential dosing period at a clinical research facility, where they are receiving both SPONTAN and a control vardenafil tablet.
A feature of the study is the inclusion of a dedicated 65+ age cohort, comprising approximately half of the total participants.
The demographic is traditionally underserved by oral therapies, which often require lower initiation doses due to increased systemic exposure.
By generating specific pharmacokinetic data for this age group, LTR Pharma aims to optimise dosing and strengthen future US labelling discussions under the FDA’s 505(b)(2) development pathway.
This follows a successful Phase 1 study that demonstrated absorption speeds five times faster than traditional oral tablets.
LTR Pharma Executive Chairman, Lee Rodne, said, "This study was identified as a key requirement during our FDA pre-IND engagement, and with dosing now underway for our final cohort, we are systematically advancing through the steps needed for our 505(b)(2) submission."