LTR Pharma has started patient recruitment for its erectile dysfunction nasal spray SPONTAN®
The study will be completed in partnership with Southern Star Research and Scientia Clinical Research
SPONTAN® designed to be a world-first, fast-acting, on-demand nasal spray treatment
Special Report: LTR Pharma has begun patient recruitment for its clinical study into SPONTAN®, designed to be a world-first, fast acting, on-demand Nasal Spray treatment for erectile dysfunction (ED).
Clinical stage biotech LTR Pharma (ASX:LTP) has kicked off patient recruitment for its pivotal bioequivalence clinical study for its innovative nasal spray treatment SPONTAN® to treat ED.
In partnership with its appointed clinical research facility, Scientia Clinical Research, the company says it is now welcoming healthy adult males to be part of the study, based out of Sydney.
The study will be overseen by Scientia Clinical Research to assess the relative bioavailability of ED drug Vardenafil following administration of SPONTAN nasal spray, when compared to oral delivery of Vardenafil tablets, a widely used PDE5 inhibitor.
LTP says current oral PDE5 tablets are gold-standard treatments for ED but have a high discontinuation rate among men with ED and can be slow acting, taking the spontaneity out of sex.
Patent-protected SPONTAN is designed to overcome the issues with oral PDE5 tablets and to be fast-acting (up to six times quicker than current treatments for ED), potentially transforming men’s lives and their relationships worldwide.
Study data to form basis for regulatory approval
The study design is a single-dose, randomised, open-label, 2-treatment, 2-period crossover study of SPONTAN nasal spray (5mg Vardenafil consisting of a single 2.5mg spray in each nostril) compared to 10mg Vardenafil tablets in healthy adult men under fasting conditions.
Each participant will be involved in the study ~4 weeks, including screening.
Pending successful completion of the study, LTP will use data in its new drug applications (NDA) with the US Food and Drug Administration (FDA) and the Therapeutic Goods Administration (TGA) in Australia for relevant regulatory approvals.
LTP’s contract research organisation (CRO) partner, Southern Star Research, will manage various aspects of the study, including monitoring, data management, safety, and pharmacokinetic analysis.
In mid-December, clinical data for SPONTAN, originally published in The Journal of Sexual Medicine, was presented at the World Meeting on Sexual Medicine (WMSM) in Dubai – where LTR Pharma’s key scientific and clinical advisor, Professor Eric Chung, was honoured with the prestigious ISSM Emil Tanagho Prize. This recognises the most innovative research data showcased at this event and is a strong endorsement of SPONTAN.
The study showed that the intranasal formulation achieved more rapid plasma concentration with one-third dose when compared with the oral administration method of delivering erectile dysfunction treatments.
Top ASX IPO for 2023
The number of men with ED in the US is ~30 million.
In Australia, more than 60% of men suffer from ED once they reach the age of 45 years or older.
The global ED market is forecast to increase to US$5.94 billion by 2028, growing at a CAGR of 7.1%.
With such strong demand for effective ED treatments, LTP hit the Aussie bourse on December 11, 2023, after a heavily oversubscribed IPO, including strong institutional support with eight fund managers on the register.
It rose 65% in its first month as a public company to be the top ASX IPO performer of 2023.
LTP chairman Lee Rodne says recruitment for the bioequivalence clinical study of SPONTAN is a significant achievement for the company and remains in line with the clearly mandated clinical and commercial milestones communicated during its recent IPO campaign.
“This study will form a critical piece of the data package we plan to submit to the FDA and TGA –supporting our plans for expedited regulatory approval for SPONTAN in key initial markets,” he says.
“We believe SPONTAN has the potential to disrupt the global blockbuster PDE5 market and we are excited to bring this innovation to men worldwide.”
LTP scientific and clinical advisor, Professor Eric Chung, says the start of the study is exciting for the company.
“We are excited to welcome appropriately screened and suitable participants to participate in the study and look forward to building a clear picture of data that helps to inform measured regulatory and clinical access pathways for novel treatments in the treatment of ED,” Chung says.
Southern Star Research managing director David Lloyd says the contract research organisation is excited to be working with LTP and Scientia Clinical Research on the study.
“This clinical trial is an exciting project for Southern Star Research and we appreciate the opportunity to work with LTR Pharma and Scientia Clinical Research,” he says.
“We are looking forward to the results, as the market potential and unmet patient needs are significant.”
This article was developed in collaboration with LTR Pharma, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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