Iconovo AB (publ), which develops complete inhalation products for a global market, today announces that the clinical phase I study of oxytocin in the company's inhaler ICOone® that was initiated earlier this year in Melbourne, Australia, is now fully recruited. The results are expected to be published in early 2024.
The study is part of a collaboration between Iconovo and Monash University to develop an inhalable oxytocin treatment based on ICOone® for the prevention of postpartum hemorrhage (PPH). PPH is the leading cause of maternal mortality worldwide, affecting around 14 million women per year and leading to up to 70,000 deaths among new mothers globally. These deaths occur mainly in low- and middle-income countries.
"We are very excited about the results of this important collaboration between Iconovo and Monash University. By combining their expertise on oxytocin and postpartum bleeding with our unique ICOone dry powder inhaler and inhalation knowledge, we have the opportunity to develop a treatment with the potential to drastically reduce the number of unnecessary and tragic deaths associated with childbirth worldwide", says Johan Wäborg, CEO of Iconovo.
The Phase I clinical trial involves healthy, non-pregnant women and is being conducted by the Nucleus Network at the Alfred Hospital in Melbourne, Australia. The study compares an inhaled heat-stable powder formulation of oxytocin in ICOone® with intramuscular injections of oxytocin (the current standard treatment for PPH). The project is led by Professor Michelle McIntosh from the Monash Institute of Pharmaceutical Sciences (MIPS).
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 a 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 lives of almost 20,000 women yearly.