Iconovo AB (publ), that develops complete inhalation products for a global market, today announces that a phase I clinical trial of inhaled oxytocin in ICOone® has been initiated in Melbourne, Australia. The study is part of the previously announced collaboration between Iconovo and Monash University.
Monash University is collaborating with Iconovo to develop an ICOone-based preventive oxytocin treatment that aims to provide women with effective protection against postpartum haemorrhage (PPH), the leading cause of maternal mortality worldwide. PPH affects around 14 million women each year, resulting in up to 70,000 maternal deaths globally. These deaths occur overwhelmingly in low- and middle-income countries.
“We are proud to support the leading experts at Monash University in the efforts to meet the huge need for easier administration of oxytocin in developing countries. Based on Iconovo’s unique dry powder inhaler ICOone and inhalation know-how, the ultimate aim is to reduce the number of unnecessary and tragic deaths in childbirths all over the globe,” said Johan Wäborg, CEO of Iconovo.
The phase I clinical trial aims to include 16 subjects and will be conducted by Nucleus Network located at the Alfred Hospital in Melbourne, Australia. It is divided into two parts, where part one is a comparison of inhaled oxytocin in ICOone® with the current standard of care (intramuscular injections of oxytocin).
The clinical trial is supported by the Commonwealth Government’s Accelerating Commercialisation Program, the Victorian Government’s Victorian Medical Research Acceleration Fund and Johnson & Johnson.
ICOone® is a unique and patented dry powder inhaler designed for single use. Its clever design provides an ultra-low manufacturing cost combined with ease and discretion of use. The simple design also allows patients and healthcare professionals to learn how to use the inhaler with minimal training. ICOone® can deliver large inhalation doses that are well protected from moisture, which is important for many biomolecules.
About postpartum hemorrhage, PPH
PPH, a condition of excessive blood loss after birth, is the leading cause of maternal mortality globally, most of which could be avoided if access to suitable medical innovation were available. In developed countries the gold standard therapy is a manufactured form of an injection with the natural hormone oxytocin.
An inhaled formulation can provide important advantages such as ease of use, cheaper transport and storage without cold chain and no handling of used needles and syringes. It is particularly important in parts of the world where infrastructure is less developed, like in rural parts of Africa or Asia. The United Nations estimates that the development of a heat-stable, inhaled oxytocin product has the potential to save the life of almost 20 000 women yearly.