A novel first-in-class treatment for male infertility
Providing solutions for building families
Clinical stage asset in Phase 2a
More than 50 million infertile couples in the world
couples have INFERTILITY problems
of cases the MAN is part of the problem
of infertile men, there is NO TREATMENT
Will provide the first treatment for male infertility
XY Therapeutics is developing a novel medical treatment for male infertility based on unique science demonstrating an important role of the RANKL/RANK/OPG pathway in the reproductive organs. The proprietary treatment has been shown to increase sperm production and function in preclinical and two clinical studies including a randomized clinical trial of infertile men. The treatment is safe and only a single injection is required to observe the expected effect.
There exist many causes for male infertility and although not all infertile men can be helped with this treatment, XY Therapeutics has identified and patented a biomarker that can select the men who will benefit from this treatment. This biomarker is currently being developed into a companion diagnostic that within minutes can allow clinicians and fertility experts to select the infertile men that will receive the treatment.
Currently, XY Therapeutics treatment is being tested in a Phase 2A trial, and expected positive result will provide a significant breakthrough in a field where there currently exists only very few available treatments for select subgroups of male infertility.
It is undoubtful that the innovation, will have a very broad impact on several aspects of citizens suffering from infertility from personal, societal and economic impact.
Effective in 50% of infertile men
Woman is spared from invasive treatments
Clinically significant increase in sperm count, motility & function
Potential for 40% spontaneous pregnancies
Lower price compared to assisted technologies
List of completed and ongoing clinical trials
Nature Publication: RANKL regulates male reproductive function
FSH & RANKL: Possible link between FSH and RANKL release from adipocytes in men with impaired gonadal function including Klinefelter syndrome
Testicular RANKL Signaling: RANKL Signaling in dysgenic testis and testicular cancer
FITMI Study: The effect of a single-dose RANKL inhibitor on semen quality in infertile men
Infertility is a global issue that is on the rise; currently it is estimated that infertility affects 15% of all couples globally, and the frequency is growing. There are multiple factors that are responsible for this increase including medical issues.
The infertility problem is a global problem but best characterized in the Western World and China. The birth rates in the European continent with the oldest population in the world have been dropping consistently from over 3 birth per woman in 1950 to 1.53 in 2019, far from the 2.1 births per woman required to keep the population size constant.
The problem is getting worse: couples reporting infertility in centers across Europe is increasing by 8-9% annually. In Denmark, 10 % of all Danish babies are born after assisted reproductive techniques (ART). This is not just a Danish issue, but also increasing globally; in the EU 1-6% of all babies are born after ART, and in the US it is 1-2% and the differences are heavily influenced by the costs for these procedures and government subsiding.
Approximately 50% of all cases are attributable to the male partner due to impaired semen quality and for 30% of all cases, infertility of the male partner is the exclusive factor. Despite the huge market potential within treating male infertility, there currently exists no evidence-based treatment that can improve semen quality i.e. sperm concentration, sperm motility and morphology in infertile men, except for a few rare diagnoses.
Instead, the use of assisted reproductive techniques (ART) has increased rapidly. In ART, the women are stimulated with hormones often for several months and multiple oocytes are harvested and fertilized in vitro by the few sperm needed for this technique. While the use of ART is a valid solution, it necessitates trained medical staff, expensive medicine, long time duration, laboratory facilities, multiple side-effects and potential long term consequences for the women, and is compromised by a higher frequency of, twin-birth, malformations etc. The multiple side-effects and consequences for the female partner is of special concern, since the female in many cases are healthy. We are in effect anno 2021, treating women for a male disease. Additionally, the financial burden for the patients and society are tremendous and the low percentage conceived after ART in some countries can be explained by an inability to pay for the treatment because it is very expensive and often several attempt and medication for several months are needed before it is successful.
There is a tremendous need for cheaper infertility treatments that can be used outside major cities with specialized clinics, but also for treatments focusing on the etiology and by reversing the problem rather than simple alleviating the symptoms. The causes for male infertility and impaired semen quality are multifactorial and so far no treatment has proved to be beneficial for male fertility in most infertile men.
XY Therapeutics impact
Disrupt the market
We will disrupt the market by offering the first treatment for improving sperm production, and additionally increasing the success rate of insemination and IVF procedures
At a much lower of the price of current ART treatments, XY Therapeutics will provide financial relief to couples and healthcare systems
Decrease invasive procedures
Martin Blomberg Jensen
MD & DMSc Harvard and Rigshospitalet
M.Sc. Biotechnology & MBA
Ida Marie Jacobsen
Ph.D Molecular Biomedicine
Professor University of Copenhagen
Prof. Imperial College
Professor University of Edinburg
Professor Harvard University