LTR Pharma has commences the initial dosing for its SPONTAN pivotal study. Pic via Getty Images.
Health & Biotech
Special Report: LTR Pharma has commenced dosing phase in its pivotal bioequivalence clinical study of SPONTAN nasal spray to treat erectile dysfunction.
Clinical stage biotech LTR Pharma (ASX:LTP) has commenced patient dosing phase in its pivotal clinical study being conducted in Sydney, which aims to assess the relative bioavailability of SPONTAN, a novel proprietary PDE5 nasal spray treatment for erectile dysfunction (ED).
SPONTAN’s unique nasal delivery technology bypasses the digestive system and is designed to overcome the issues of oral tablets for ED by having a significantly faster onset of action within 10 minutes. Its key peers include an established class of oral tablets called PDE5 inhibitors, encompassing household names like Viagra. However, these tablets have a high discontinuation rate due to the lengthy wait time for the product to take effect and potential interference of normal digestion (of food and alcohol) in their mechanism of action too.
The study is designed to test the same drug, administered two different ways. It 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 of the 18 participants will be involved in the study for ~4 weeks, including screening.
LTP’s contract research organisation (CRO) partner, Southern Star Research, will oversee multiple facets of the study, encompassing monitoring, data management, safety, and pharmacokinetic analysis.
LTP says ED is characterised by the inability to achieve or maintain an erection firm enough for satisfactory sexual intercourse.
It can persist as a short-term or long-term issue, leading to relationship strain and mental health concerns.
It is estimated that 30 million men in the US experience ED, with more than 60% of men in Australia developing ED after the age of 45.
Since the introduction of a class of medications known as PDE5 inhibitors in 1998, including the renowned Viagra, men have had access to oral pills to address ED.
However, a prevalent issue with many of today’s ED medications is their relatively slow onset of action, often requiring at least an hour before users can achieve full sexual capacity – and not always working as desired, due to digestive variables too (think food, alcohol).
SPONTAN is aiming to restore the spontaneity of sexual encounters, offering on-demand delivery with significantly faster onset of action within 10 minutes than traditional pills.
With firm demand for efficient ED remedies, LTP hit the ASX on 11 December 2023, following an IPO that was significantly oversubscribed with substantial institutional backing.
The worldwide market for ED is projected to reach $5.94 billion by 2028, with a compound annual growth rate (CAGR) of 7.1%.
Subject to successful conclusion of the study, LTP intends to use the data for its new drug applications (NDA) with the US Food and Drug Administration (FDA) and the Therapeutic Goods Administration (TGA) in Australia to seek pertinent regulatory approvals.
In December 2023, clinal 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.
The data showed the intranasal formulation achieved more rapid plasma concentration with one-third dose when compared with the oral administration method of delivering ED treatments.
LTP chairman Lee Rodne says with the pivotal trial results expected in mid-2024, the company is optimistic about SPONTAN nasal spray’s ability to significantly impact the ED treatment landscape.
“The study is off to a great start and the company is grateful to the participants interested in entering the study,” he says.
“SPONTAN nasal spray represents a potential paradigm shift in the treatment for erectile dysfunction and is a promising disruptor to the global blockbuster PDE5 market, offering a discreet and efficient treatment alternative.
“We are excited to bring this key innovation to men worldwide.”
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.
Health & Biotech
Health & Biotech
Health & Biotech
