LTR Pharma doses first patient with Erectile Dysfunction nasal spray

In their attempt to provide men with alternative treatments for Erectile Dysfunction (ED), LTR Pharma (ASX: LTP) has commenced dosing its first cohort of human patients with their SPONTAN nasal spray. 

Erectile Dysfunction affects millions of men globally, hampering individuals’ ability to achieve or maintain an erection suitable for sexual intercourse, leading to relationship strains and mental health concerns.The exact reasoning for rising ED rates is questionable, but contributed to via a combination of increased reporting rates and lifestyle changes in the digital era.  

The clinical study has progressed in part due to funding secured by LTR from their IPO in November 2023 which raised $7 million at an Offer Price of $0.20 per share. 

The study will dose 18 patients and aims to meet FDA requirements with each patient to be dosed with two treatments in a randomised 2-period crossover study. 

Participants, healthy adult male subjects, will receive either SPONTAN nasal spray or Vardenafil tablets under fasting conditions, with a duration of involvement of approximately 4 weeks per participant, including screening. The study results are anticipated in mid-2024.

“The Study is off to a great start, and we are grateful to the participants interested in entering the study,” said LTR Pharma Executive Chairman, Lee Rodne. 

“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.” 

SPONTAN nasal spray aims to address this pressing health issue by offering a discreet and efficient alternative to conventional oral tablets. Unlike traditional oral medications, SPONTAN leverages intranasal delivery technology, enabling rapid absorption of the active ingredient, Vardenafil, within the highly vascular nasal cavity. This mechanism empowers SPONTAN to take effect within 10 minutes or less, providing users with greater spontaneity and control over their sexual experiences.

The ongoing bioequivalence study seeks to evaluate the relative bioavailability of SPONTAN compared to oral administration of Vardenafil tablets, a widely used PDE5 inhibitor. 

LTR Pharma has a stated mission to enhance men’s health physically and mentally. By restoring spontaneity and enhancing sexual satisfaction, SPONTAN seeks to empower individuals and alleviate the emotional toll of ED on self-esteem and relationships across various age groups.

For the Half Year ended 31 December 2023, LTR Pharma reported a $2.5m net loss. This was more than the previous corresponding period’s $0.6m loss but largely associated with admin and finance costs linked to the Company’s IPO with $6m of cash on hand at the end of December 2023.