LTR Pharma has initiated dosing in its Phase II clinical trial for SPONTAN, a rapid-acting intranasal spray targeting erectile dysfunction, marking a key step toward FDA approval and commercial expansion.
- First patients dosed in SPONTAN Phase II pharmacokinetic study
- Study includes approximately 27 healthy males, half aged 65 or older
- Initial data expected in Q2 2026 to support FDA regulatory submission
- Focus on pharmacokinetics to inform dosing for older patients
- SPONTAN aims to offer rapid onset treatment for erectile dysfunction
Clinical Milestone Achieved
LTR Pharma Limited (ASX – LTP) has reached a significant milestone with the dosing of the first patients in its Phase II pharmacokinetic study of SPONTAN, a novel intranasal spray designed to treat erectile dysfunction (ED). This development signals the transition from recruitment to active data generation, a crucial step in the company’s clinical and regulatory journey.
Study Design and Objectives
The study involves approximately 27 healthy male participants divided into three cohorts, with about half aged 65 years or older. This age stratification aligns with FDA guidance on geriatric-use assessments, addressing a key demographic often requiring tailored dosing strategies due to physiological differences and comorbidities. The trial will evaluate both single- and multiple-dose pharmacokinetics, providing insights into how SPONTAN is absorbed, distributed, metabolised, and eliminated in the body.
Regulatory and Commercial Implications
Data from this Phase II study is expected by the second quarter of 2026 and will form a critical component of LTR Pharma’s submission to the US Food and Drug Administration (FDA). The pharmacokinetic profile, especially in older men, is anticipated to inform prescribing information and dosing recommendations, potentially differentiating SPONTAN from existing oral ED therapies that often require dose adjustments in this population.
Executive Chairman Lee Rodne emphasised the importance of this milestone, noting that the study’s outcomes will support both regulatory approval and the company’s broader commercial strategy in the US market. With SPONTAN’s rapid onset of action; promising effects within 10 minutes or less; the product aims to fill a niche for patients seeking fast and effective ED treatment.
Broader Pipeline and Strategic Outlook
Beyond SPONTAN, LTR Pharma is advancing other intranasal therapies, including ROXUS, another ED treatment, and OROFLOW, targeting oesophageal motility disorders. The company’s proprietary intranasal delivery platform underpins these innovations, offering a patient-centric approach that could reshape treatment paradigms in multiple therapeutic areas.
As LTR Pharma continues to generate clinical data and navigate regulatory pathways, investors and industry watchers will be keen to monitor upcoming results and the company’s progress toward commercial launch in the US.
Bottom Line?
SPONTAN’s Phase II progress sets the stage for a pivotal FDA submission and potential market disruption in ED treatment.
Questions in the middle?
- How will SPONTAN’s pharmacokinetic data compare to existing oral ED therapies in older patients?
- What are the timelines and expectations for FDA approval following Phase II data release?
- How might LTR Pharma’s intranasal platform influence competitive dynamics in the ED market?