LTR Pharma’s SPONTAN nasal spray achieves superior results in erectile dysfunction clinical study

LTR Pharma (ASX: LTP) has come out of a trading halt with the announcement of successful results from a pivotal bioequivalence clinical study into a breakthrough treatment for erectile dysfunction (ED).

The company’s share price jumped by 37% after initial results from the study of LTR’s SPONTAN first-in-kind nasal spray treatment found it achieved rapid absorption and faster onset of action compared to well-known oral treatments.

LTR chair Lee Rodne said the early data indicated that SPONTAN reached the same maximum concentration level as an oral administration, despite being administered at a lower dose.

Rapid reaction

That result was achieved in as little as nine minutes, with an average of 12 minutes across the study, compared to 56 minutes in patients receiving oral treatment.

“SPONTAN has the potential to make a significant impact on the global PDE5 inhibitor market, providing men with a more convenient and effective solution for ED,” Mr Rodne said.

“This study further underscores the rapid onset of action of SPONTAN and represents a significant advancement over existing gold-standard oral therapies, which can take over an hour to take effect.”

“This milestone brings us closer to our mission of enhancing men’s health and quality of life.”

It has been reported that more than half of men between the ages of 40 and 70 experience some form of ED, with the global treatment market for the condition valued at around $7 billion in 2023.

Improved profile

Mr Rodne said that SPONTAN also demonstrated an improved safety and tolerance profile, providing reassurance and confidence in its use.

The study also showed better consistency in response for the nasal spray patient cohort, thus achieving both primary and secondary endpoints.

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.

Clinical study pathway

In late March, LTR reported that participants in the clinical study of SPONTAN had received their second and final dose, completing the recruitment and dosing stage of the clinical study.

The study evaluated the relative bioavailability of SPONTAN compared to oral administration of Vardenafil, a widely used PDE5 oral tablet.

Data collected from the study will be used to support the pre-submission meetings with the Food and Drug Administration and prescriptions of SPONTAN via the early access scheme in Australia.