Newsroom: In the News

Q: WHAT’S THE PROBLEM IN FERTILITY?

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As highlighted last month at ESHRE, fertility challenges are rising. With the WHO estimating infertility affects around 48 million couples, and 186 million individuals, this is a global public health challenge. We’re talking 1 in 6 couples globally having infertility issues. Yet despite this, there have been no major innovations for over 40 years and there’s still no therapeutic treatment for male infertility.

At ESHRE there was a lot of focus on this ‘male’ factor in infertility. Despite sperm counts dropping around 2.5% a year throughout this millennium, the standard of care in infertility treatment continues to mainly focus on the woman. This involves expensive and physically and mentally demanding IVF regimes that typically result in around a third of women discontinuing treatment. For those who do complete treatment there’s only an average 25-30% success rate depending on age.

In short, as infertility is 50% men and 50% women related, this is very much a couples problem. Trying to solve just one part of the puzzle doesn’t always help us in solving this complex problem. Couples deserve a better chance to build a family.

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Q: WHAT IS IGYXOS DOING TO HELP WITH THIS PROBLEM?

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At Igyxos we’re on a mission to improve fertility for everyone. We’ve been looking closely at this from a molecular biology angle, getting right down to the fundamental building blocks of biology. We are focusing on Follicle Stimulating Hormone (FSH), a key hormone in gametogenesis, which is the formation of eggs and sperm. Enhancing FSH’s bioactivity could give genesis to a completely innovative approach to treating infertility.

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To do that, we have developed IGX12, a first-in-class therapeutic monoclonal antibody, which potentiates FSH. IGX12 binding to FSH results in a better activation of FSH receptor and increased response in target cells and thereby improves gametogenesis. Our in vitro and in vivo preclinical work has confirmed a significant increase in potency and efficacy of FSH.

For men, we’re lining up IGX12 to be the first treatment to market for oligozoospermia, defined as a low sperm count of fewer than 15 million sperm per ml. For women, especially for those where IVF doesn’t work well, there’s a significant opportunity to improve the success rate, and reduce the cost, of the standard of care.

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Q: WHERE’S IGYXOS IN THE DRUG DEVELOPMENT PROCESS?

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We have results coming up in Q4 2025 from our Multiple Ascending Dose (MAD) cohorts in a Phase 1 trial of IGX12. We’ve already announced, in March 2025, our positive single ascending dose (SAD) results, which our Chief Medical Officer, Elke Bestel, also presented at ESHRE, showing the approach is safe and well tolerated. We are excited about embarking on Phase 2 studies in 2026.

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Q: IN CLOSING, DO WE REALLY NEED THIS? ISN’T INFERTILITY A ‘LUXURY’ ISSUE?

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Yes, we really do. Infertility is an issue that is not going away, in fact the unmet need is increasing at alarming rates. For some individuals, fertility can be crucially important, the very stuff that their hopes and dreams are made from.

Infertility is also affected by lifestyle (such as sleep quality and tobacco use), environmental exposures (including air pollution and human-made chemicals), as well as underlying chronic diseases, such as diabetes and obesity. These lifestyle and environmental influences highlight the importance of education and prevention alongside innovation.
There has been a lack of innovation in infertility for the last 40 years and we believe that new approaches, like ours, are urgently needed.