First Patients Dosed in SPONTAN® Phase II Clinical Study

LTR Pharma has announced that the first patients have been dosed in its Phase II pharmacokinetic clinical study of SPONTAN®, its rapid-acting intranasal spray for the treatment of erectile dysfunction. 

This marks the transition of the study into active pharmacokinetic data generation, representing a significant execution milestone for the Company.  The study is expected to recruit 27 healthy male participants across three cohorts, including a significant proportion aged 65 years and older, consistent with FDA expectations for geriatric-use assessments. 

The resulting data is expected to play an important role in advancing SPONTAN’s U.S. regulatory pathway and supporting the Company’s broader commercial strategy.  

LTR Pharma Executive Chairman, Lee Rodne, said: 

“With first patients now dosed, our Phase II program is now actively generating data. This study will complete an important component of our FDA regulatory package, including pharmacokinetic insights for older patients that often require dose adjustments with oral ED therapies.” 

Click to read the ASX release.