SPONTAN® Phase II study: Positive interim data read-out

LTR Pharma is pleased to share that the interim data analysis from the Phase II study of SPONTAN®, indicating a pharmacokinetic profile distinct from oral PDE5 inhibitors, consistent with rapid-onset, on-demand use across both adult and geriatric populations. 

Key highlights: 

• Median Tmax of 10 minutes for SPONTAN® (5 mg) versus 60 minutes for oral vardenafil (20mg), consistent with Phase I study. 

• Interim data provide the key pharmacokinetic dataset requested by the FDA, including rapid absorption, repeat-dose profile, with no drug accumulation observed, and consistent pharmacokinetics across adult and geriatric populations. 

• Pharmacokinetic profile in subjects ≥65 years comparable to adults in the dataset, addressing a key FDA Pre-IND requirement. 

• Consistent safety profile observed, with no serious adverse events, no Grade 3 or 4 treatment-emergent adverse events, and no treatment-related discontinuations.  

• No drug accumulation observed following five days of repeat intranasal dosing (5 mg).  

Together, these findings support SPONTAN®’s differentiated rapid-onset profile, including consistent pharmacokinetics on repeat dosing, and support its potential relevance across a broad patient population, subject to final analysis. 

These interim data are expected to inform the Company’s FDA 505(b)(2) regulatory strategy, with final results, including full statistical analysis, due in Q3 CY2026. 

 LTR Pharma’s Executive Chairman, Lee Rodne, commented:  

 "The interim Phase II data are consistent with our Phase I findings and reinforce SPONTAN's differentiated rapid-onset profile, including in men aged 65 and over, a group that often requires dose adjustment with oral PDE5 therapies. Importantly, no serious adverse events, no severe treatment-emergent events, and no treatment-related discontinuations were observed. This Study was specifically designed in accordance with FDA Pre-IND guidance, and we are now focused on completing the statistical analysis and progressing our 505(b)(2) regulatory strategy in the United States." 

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