A 2022 review highlighted a troubling trend: human sperm counts in adult males have steadily declined globally. Since 1973, sperm counts have dropped an average of 1.2% per year, falling from 104 million to 49 million per milliliter through 2019. Since then, this decline has accelerated to more than 2.6% per year since 2020. Although the causes of reduced counts remain unclear, recent studies suggest that microplastics, which leach endocrine-disrupting chemicals into the body, may be a contributing factor.
“Lower sperm counts may affect the ability to conceive,” said René Frydman, Professor at Foch Hospital in Suresnes, France. “Historically, treatments have focused on women, yet reduced sperm count and quality are major factors in as many as half of infertility cases.”
Infertility affects up to 186 million individuals worldwide, with approximately 48 million couples seeking medical assistance. For over 50 years, physicians have relied on Follicle-Stimulating Hormone (FSH) injections to treat infertility.
“FSH is an effective treatment approach in some cases, but it’s not a complete solution. On average, it takes women undergoing treatment with FSH four to five treatment cycles of up to 20 injections per cycle over two years to achieve a 60-70% success rate. Additionally, FSH fails to address male infertility,” Frydman noted.
Scientists at Igyxos Biotherapeutics, an emerging biopharmaceutical company specializing in infertility solutions, are developing a novel therapeutic addressing both female and male infertility. IGX12 is a first-in-class monoclonal antibody (mAb) with a completely new mode of action designed to boost the bioactivity of endogenous FSH, naturally found in the body. This innovation aims to significantly reduce the number of hormonal injections needed.
Animal studies have shown that IGX12 produces a superior ovarian response in females and increases spermatogenesis in males. It is the first new molecule patented for infertility in over 40 years. If it achieves regulatory approval, it will also be the first and only treatment for male infertility available to patients and their physicians. IGX12 is currently being evaluated in a Phase 1 clinical study.
“Because IGX12 could potentially treat both male and female infertility, a couple could be treated simultaneously to increase chances of success. Importantly, it could help reduce the burden on women by reducing the number of injections and enabling couples to share in the treatment process,” said Marie-Christine Maurel, Ph.D., Chief Science Officer & Founder at Igyxos. “IGX12 is designed to enhance the bioactivity of endogenous FSH, which is critical to both male and female reproductive processes. By improving FSH receptor binding and activation, IGX12 aims to increase male sperm counts and ovulation in females.”