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

only the woman is treated for a male’s disease
XY Therapeutics is based on more than 10 years of research from Kingdom Hospital in Copenhagen Denmark, with the focus on developing new treatment solutions for infertile couples. 

XY Therapeutics

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

Relevant publications

  • 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

Price Reduction

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

We will spare women from invasive procedures in 50% of infertility couples

Savings

152M savings due to no absence from work in the EU

Assistance procedures

Up to 12% babies born by assistant reproductive techniques

Management team

Martin Blomberg Jensen

Martin Blomberg Jensen

MD & DMSc Harvard and Rigshospitalet

Founder & CEO
Lasse Nørregaard

Lasse Nørregaard

M.Sc. Biotechnology & MBA

Chief Business Officer
Ida Marie Jacobsen

Ida Marie Jacobsen

Ph.D Molecular Biomedicine

Scientist

Business Advisors

Arnoud Klokke

Arnoud Klokke

Business Developer

Novo & BioInnovation Institute

Jakob Lohman

Jakob Lohman

IP

P&V

Greg Jones

Greg Jones

Vice President

Legal Affairs Novo Nordisk

Scientific Advisors

Anders Juul

Anders Juul

Professor University of Copenhagen

Rigshospitalet

Ilpo Huahteniemi

Ilpo Huahteniemi

Prof. Imperial College

Richard Anderson

Richard Anderson

Professor University of Edinburg

Roland Barron

Roland Barron

Professor Harvard University

Partners

Rigshospitalet
University of Copenhagen
Novo Nordisk Fonden Bio Innovation Institue

Forskningsgennembrud giver håb om ny behandling til mænd med lav sædkvalitet

Forskere fra Rigshospitalet og Harvard University har som de første i verden vist, at et lægemiddel mod knogleskørhed også øger antallet af sædceller hos mænd med lav sædkvalitet. Lægemidlet kan være en ny, lovende behandlingsform til mænd med nedsat sædkvalitet.

Contact

XY Therapeutics

 

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