LTR Pharma Reports 93% SPONTAN Response in Real-World ED Cohort

LTR Pharma (ASX: LTP) has reported a 93% response among treatment-experienced men seeking greater convenience and spontaneity in the largest real-world cohort assessed to date for its rapid-onset intranasal erectile dysfunction (ED) treatment SPONTAN.

The retrospective Australian cohort covered 147 men previously treated with oral ED therapies, with 68% overall reporting improved erectile hardness and/or achieving penetration after using SPONTAN.

Results were also encouraging in a harder-to-treat post-prostatectomy group, where 64% of 87 men reported the same composite response, while 57% of 102 men who had previously reported inadequate efficacy with oral therapy responded.

The findings are derived from patient-reported outcomes in a retrospective single-centre cohort, with a manuscript undergoing peer review and LTR planning further investigation alongside its continuing commercialisation work in both Australia and the US.

Post-Surgery Group Focus

LTR highlighted the 64% response among post-prostatectomy patients because ED can remain difficult to treat following prostate cancer surgery and some patients receive limited benefit from oral medicines.

The company is evaluating a prospective study in this population and will continue collecting Australian real-world evidence as the current manuscript progresses through peer review.

SPONTAN is not registered on the Australian Register of Therapeutic Goods and is available in Australia through the Therapeutic Goods Administration’s Special Access Scheme and Authorised Prescriber pathways.

LTR is advancing SPONTAN through the 505(b)(2) regulatory pathway in the US while preparing rapid-acting intranasal ED treatment ROXUS for US availability through patient-specific prescriptions.

The company has executed agreements with Shed Holdings and Strive Specialties, and considers the latest real-world evidence potentially useful for engagement with urologists, men’s health prescribers and commercial partners.

Real-World Cohort Response

The 147 participants had a mean age of 65.6 years, all had previously used oral treatments and 62% had a history of prostate cancer, while 59% had undergone prostatectomy.

Men were grouped by whether they were seeking greater convenience and spontaneity or improved efficacy after an inadequate response to oral treatment, with respective response rates of 93% and 57%.

“The 93% response among men seeking greater convenience reinforces our belief that the opportunity for SPONTAN and ROXUS extends beyond patients who simply fail oral tablets—it includes men seeking greater spontaneity and control over their treatment,” executive chair Lee Rodne said.

“With our commercial partnerships now in place, these findings provide an important clinical narrative as we engage urologists, men’s health prescribers, and commercial partners ahead of ROXUS US availability.”