EVE Health Group (ASX: EVE) has initiated a pilot clinical study for vardenafil oral soluble film Libbo for the treatment of erectile dysfunction (ED).
The study is designed to compare the pharmacokinetic profile of Libbo 10 milligram dose against an Australian-registered reference vardenafil tablet under fasted conditions in healthy male subjects.
It represents the first clinical step in the company’s planned bioequivalence development program for the drug and is expected to form a key component of its regulatory registration pathway.
Libbo’s oral soluble film is a rapidly dissolving formulation that provides a discreet and convenient alternative to conventional ED tablets, along with potential advantages in convenience and user experience over traditional tablet presentations to be assessed as part of the study protocol.
Subject recruitment and study activities are expected to advance over the coming weeks, with study results anticipated before end September.
Bioequivalence Program
EVE chief executive officer Ben Rohr called the pilot study a key milestone in Libbo’s development.
“The study is designed to provide valuable information to support the design of our planned pivotal bioequivalence program and represents an important step toward the planned pivotal bioequivalence study and the commercialisation of a differentiated ED treatment,” he added.
Mr Rohr was appointed to the role in April after a stint as chief operating officer, during which he was instrumental in the company’s operational and commercial progress.
He has also been closely involved in positioning Libbo and Dyspro (to treat dysmenorrhea and endometriosis) for regulatory progression and rollout to target markets.
Reformulated Products
Libbo has been developed as a rapid-delivery spray formulation of oral PDE5 inhibitor vardenafil and aims to provide faster onset and improved patient convenience and efficacy while avoiding the alcohol-based systems used in similar products.
EVE is working on a reformulated version of short-acting selective serotonin reuptake inhibitor dapoxetine to treat premature ejaculation, offering improved delivery characteristics, ease of administration, faster absorption, and more predictable dosing.
It has also designed a novel, dual-acting spray formulation combining vardenafil and dapoxetine for patients experiencing ED and premature ejaculation, which frequently occur together.
In October, EVE received strong support from sophisticated and professional investors for a $1.1 million capital raising aimed at accelerating a commercial rollout of the two products.