Monash University completes recruitment for inhaled oxytocin clinical trial
21 September 2023
Professor Michelle McIntosh
A Monash-led Phase 1 clinical trial to assess the safety and performance of a novel oxytocin inhaler is now a step closer to completion with the conclusion of subject recruitment conducted by Nucleus Network located at the Alfred Hospital.
The trial recruited healthy, non-pregnant female volunteers to investigate a new administration method of the already approved drug oxytocin - a hormone given to women in childbirth to prevent postpartum haemorrhage (PPH) - in comparison to the existing injectable products.
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 PPH comparable to existing gold standard therapies.
Data from the Phase 1 clinical trial is expected to be released by early 2024.
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,” Professor McIntosh said.
“In this trial we’re testing inhaled oxytocin in healthy non-pregnant female 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 medicine that doesn’t require refrigeration, is non-invasive, simple to use and affordable.”
In this trial, the healthy volunteers have received 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 where access to high quality oxytocin injection products is limited due to the requirement for refrigerated storage to prevent deterioration and skilled personnel for safe administration, both of which can be lacking in these settings.
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 without any significant safety issues.
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, 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.
The 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.
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