Clinical trial of inhaled oxytocin to reduce maternal mortality underway in Melbourne

Monash University

A Phase 1 clinical trial led by Monash University to assess the safety and performance of a novel oxytocin inhaler in healthy, non-pregnant female volunteers has commenced in Melbourne.

The Inhaled Oxytocin Project, led by Professor Michelle McIntosh from the Monash Institute of Pharmaceutical Sciences (MIPS), has developed a heat-stable powder formulation of oxytocin that, when inhaled, aims to provide protection against postpartum haemorrhage (PPH) comparable to existing gold standard injection products. Professor McIntosh said the driving force behind the Inhaled Oxytocin Project is to ultimately develop an effective inhaled oxytocin to greatly improve access to this medicine in countries that need it the most.

“Our focus is on developing a product that will play a vital role in addressing the unacceptably high number of preventable PPH-related deaths in low- and middle-income countries,” said Professor McIntosh.

“In this trial we’ll be testing inhaled oxytocin in 16 healthy volunteers to assess the performance of the product and, hopefully, accelerate the project towards commercialisation of manufacturing activities and late-stage clinical development.”

“The ultimate goal is to develop an inhaled oxytocin device that doesn’t require refrigeration, is non-invasive, simple to use and affordable,” Professor McIntosh concluded.

In this trial, the healthy volunteers will receive oxytocin via the Iconovo ICOone inhaler, a novel, low-cost, easy to use inhaler device. This simple aerosol delivery system, combined with Monash’s novel formulation technology, eliminates the need for cold chain storage and overcomes the barriers associated with injection delivery when used in low- and middle-income countries. PPH is the leading cause of maternal mortality world-wide, with around 14 million women experiencing PPH each year, resulting in up to 70,000 maternal deaths globally. These deaths occur overwhelmingly in low- and middle-income countries. This trial aims to demonstrate that oxytocin, whether administered from a novel, easy-to-use, low cost inhaler device or by intramuscular injection, results in similar concentration profiles in the blood. Monash signed a development agreement with the Swedish-based Iconovo in 2020, providing a licensing option to the exclusive global right to use ICOone with oxytocin to prevent PPH in women giving birth. The Inhaled Oxytocin program has progressed from early proof-of-concept through to phase 2 clinical development with prior support from GSK, Janssen Pharmaceutica N.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson (Johnson & Johnson), and a number of philanthropic partners. Development and commercialisation partners are sought to further progress this important innovation and ultimately provide access to mothers in need.

This study has been generously funded by grants from the Australian Government Department of Industry, Science and Resources through AusIndustry’s Entrepreneurs’ Programme, the Victorian Government’s Victorian Medical Research Acceleration Fund and Johnson & Johnson.

/Public Release.