By Digifin Pty Ltd · About this coverage
Key Points
- Final Phase II CSR completes FDA pharmacokinetic dataset for planned 505(b)(2)
- SPONTAN 5 mg median Tmax 10 minutes versus 60 minutes for 20 mg oral tablet (p<0.0001)
- No drug accumulation over five days; comparable PK in 14 of 27 men aged 65+
- No serious adverse events, Grade 3+ events or discontinuations across doses
- Submission-enabling work 2H CY2026; pivotal Phase III targeted 1H CY2027
About LTR Pharma (ASX:LTP)
LTR Pharma Limited is an ASX-listed pharmaceutical company headquartered in Australia. It develops and commercialises intranasal therapies, including SPONTAN and ROXUS sprays for erectile dysfunction, and is advancing OROFLOW for oesophageal motility disorders.
LTR Pharma (ASX:LTP) confirmed that the final Clinical Study Report for the SPONTAN Phase II pharmacokinetic study supports the interim results announced on 1 May 2026 and completes the FDA-agreed pharmacokinetic dataset for its planned U.S. 505(b)(2) submission.
The report, prepared by Southern Star Research, showed SPONTAN reached median Tmax in 10 minutes at the 5 mg dose and 11 minutes at 2.5 mg, versus 60 minutes for the 20 mg oral vardenafil tablet, with the SPONTAN 5 mg versus oral difference statistically significant (p<0.0001). Exposure was approximately dose-proportional, metabolite exposure was substantially lower than the oral tablet, five days of once-daily dosing showed no drug accumulation, and pharmacokinetics were comparable in the 14 of 27 participants aged 65 and over. The safety analysis reported no serious adverse events, no Grade 3 or higher events and no discontinuations across doses. The randomised open-label three-way crossover study in 27 healthy adult males was conducted at Scientia Clinical Research in Sydney. Submission-enabling activities are scheduled for 2H CY2026, with the pivotal Phase III study targeted to commence in 1H CY2027.
Next steps still include CMC package finalisation, human factors validation, leachables and non-clinical toxicology, and outcomes of licensing and regulatory engagement.
Source: LTR Pharma Limited (ASX:LTP), 1 October 2026. Summary content supplied by Digifin Pty Ltd.
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