Postpartum haemorrhage is the leading cause of maternal mortality globally, especially in developing countries. Monash University is collaborating with Iconovo to develop an inhalable, preventive oxytocin treatment that aims to provide effective protection against these bleedings. Iconovo was recently able to announce that Monash has started a clinical phase I study with the treatment in Melbourne. In addition, the product is featured in Designing Motherhood, an international design exhibition. Måns Österberg at Iconovo tells us more about the project.

Childbirth is for many an amazing experience, but for some women, it can develop into a life-threatening situation. There is a risk that the mother gets an extensive bleeding after childbirth due to tissue damage, or that the uterus does not contract properly.

Postpartum haemorrhage – the most common cause of maternal mortality

These bleedings are called postpartum haemorrhages and can quickly develop into heavy blood loss and a life-threatening condition for the mother. Postpartum haemorrhage is estimated to cause 60,000 deaths per year and is thus the most common cause of maternal mortality globally. Most deaths occur in low- and middle-income countries. Many of the deaths could be prevented with oxytocin.

Preventive treatment with oxytocin

To prevent postpartum haemorrhage, the WHO recommends that women should receive an injected dose of oxytocin during the third stage of labour, i.e. when the baby has been born. Oxytocin is known to be a “feel-good hormone”, but it also has an important role in childbirth as it helps the uterus to contract, both during labour and after childbirth.

By adding synthetic oxytocin, postpartum bleeding can be effectively prevented. Oxytocin is currently only available in an injectable form that requires an unbroken cold chain during transport and storage. In addition, healthcare professionals are needed to give the treatment safely. This means that the treatment is not available to the same extent in low- and middle-income countries.

Collaboration between Iconovo and Monash University

Iconovo och Monash University want to change this by developing a product in which the oxytocin is inhaled instead of injected. Inhaled oxytocin can provide many advantages: ease of use, cheaper transport and storage without cold chain and no handling of potentially hazardous needles and syringes.

The idea of inhaled oxytocin came from Monash University, which chose to use Iconovo’s solid experience and expertise in inhalation to realize the vision. At the end of 2020, they entered into an agreement that gives Monash an exclusive global right to use Iconovo’s single-use inhaler ICOone with oxytocin to prevent postpartum haemorrhage.

ICOone has a very low manufacturing cost and is easy to use, which makes it well suited for the project. Through the agreement, Iconovo is entitled to milestone-based payments during the development work, as well as sales-based royalties after launch.

Start of study in Australia

Iconovo recently announced that Monash University has started a clinical phase I study with the oxytocin treatment at Alfred Hospital in Melbourne, Australia. The study includes 16 subjects and is divided into two parts, where the first part compares inhaled oxytocin in ICOone with the current standard treatment which is intramuscular injections of oxytocin. The clinical trial is supported by the Commonwealth Government’s Accelerating Commercialisation Program, Victorian Government’s Victorian Medical Research Acceleration Fund and Johnson & Johnson.

Included in an international exhibition

The ICOone-based oxytocin treatment is also included in the Designing Motherhood exhibition that contains over 100 objects that have made a difference or are expected to make a difference in fertility, pregnancy, childbirth and parenthood. The exhibition takes place at the Gates Foundation Discovery Center in Seattle, USA, but will later travel around the world to various museums.

Interview with Iconovo’s Måns Österberg about the project

Måns Österberg, Director Alliance Management at Iconovo, is responsible for contact with Monash University. BioStock talked to Måns about the possibilities of the oxytocin project and the exhibition Designing Motherhood.

First, what is your your role at Iconovo?

– I am Alliance Director, meaning that I have a role between the customer and our development work. You could say that I connect the business development with the technical development.

Why is postpartum haemorrhages still a big problem when there is a treatment available?

– Oxytocin is an effective prophylactic treatment that is given to all mothers in Sweden and in other resourceful countries. Oxytocin is also available in poor countries, but the quality is bad and unregulated. It is difficult to keep cold chains on the countryside and ensure the quality and effect of the treatment. Additionally, there are not always healthcare professionals nearby that can give the injection.

What are the advantages of inhaled oxytocin over injectable oxytocin for the treatment of postpartum haemorrhage?

– There are several advantages of inhaled oxytocin in ICOone. A dry powder is more stable and not as heat sensitive as an injectable formulation. Another important advantage is that ICOone is intuitive to use and that no nurse is needed to give the treatment. In addition, our product has a low manufacturing cost, while maintaining high quality.

»There are several advantages of inhaled oxytocin in ICOone. A dry powder is more stable and not as heat sensitive as an injectable formulation. Another important advantage is that ICOone is intuitive to use and that no nurse is needed to give the treatment. In addition, our product has a low manufacturing cost, while maintaining high quality«

– Oxytocin itself is cheap to produce as the manufacturing process is well established. This means that there is already cheap oxytocin on the market, however, it is not as good as in our product. This makes us competitive on the oxytocin market.

How far has Monash University come in the project?

– Monash University has started start a phase I clinical trial with the oxytocin treatment. The purpose of the study is to evaluate safety and pharmacokinetics to ensure that the oxytocin enters the blood as it should.

– Monash University has previously tested the inhalable oxytocin in clinical studies, showing that the treatment principle works well and that the inhaled oxytocin gives the same effect as injected oxytocin. However, they have used another inhaler that was too expensive for the project. Therefore, they searched for better and more cost-effective alternatives and found our inhaler ICOone. ICOone will be used in the clinical studies as well as in the commercialisation of the product.

What does the study with inhaled oxytocin mean for Iconovo?

– It is a phase I study, i.e. early phase, but it is still very important for Iconovo. A dosing study like this shows that ICOone can be used to administer a biomolecule (peptide) to the lung for systemic effect. It is also proof that Iconovo’s “Replace injection” vision is realistic and really increases access to important treatment for many people.

»It is a phase I study, i.e. early phase, but it is still very important for Iconovo. A dosing study like this shows that ICOone can be used to administer a biomolecule (peptide) to the lung for systemic effect«

– Iconovo works actively with the UN’s third goal for sustainable development, Health and well-being. The study that Monash is now conducting is a step towards better health for women giving birth.

What is the market potential for the product?

– We see that inhaled oxytocin can benefit women in parts of the world where the infrastructure is less developed, such as in rural areas in Africa and Asia. We estimate that the product can be used in 15-20 percent of births in rural areas.

»We see that inhaled oxytocin can benefit women in parts of the world where the infrastructure is less developed, such as in rural areas in Africa and Asia […] There is also an opportunity to launch the product in more developed markets«

– There is also an opportunity to launch the product in more developed markets, such as Europe and the USA, as these markets could also benefit from a safe, non-invasive alternative to today’s injection treatment. There are also other potential niche markets, such as women who want to give birth at home. They are probably willing to pay more to avoid the oxytocin injection.

What does it mean for Iconovo that the ICOone based oxytocin treatment gets to be part of the exhibition Designing Motherhood?

– It is of course a recognition for the design in ICOone to be part of Designing Motherhood, which is a design exhibition highlighting innovations in maternal health. The exhibit travels around to various big museums and is currently at the Gates Discovery Center in Seattle. Before that, it was at the MassArt Art Museum in Boston.

– ICOone is designed to be easy to use and cost-effective to manufacture. In addition, no medical staff are needed to use the inhaler.

Finally, what could the project mean for Iconovo in the long run?

– During the course of the project, we will receive milestone payments and then sales-based royalties of between 5-10 percent. The project will probably not provide huge financial benefits, but we might be able to help thousands of people who need a simple, cheap, and effective treatment for postpartum haemorrhage.

– For us, it is also important to show that the treatment concept works as it can pave the way for more projects with the goal of replacing injection with inhalation – which is our main mission.

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