Gameto, a clinical-stage biotech company, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Fertilo, an induced pluripotent stem cell (iPSC)-based therapy. This clearance paves the way for the first U.S.-based Phase 3 clinical trial of an iPSC therapy in reproductive medicine.
Fertilo utilizes Gameto's ovarian support cell (OSC) technology, which is designed to mature eggs outside the body using iPSC-derived cells. This innovative approach aims to replicate the natural egg maturation process in a laboratory setting, offering a potentially less invasive and more efficient alternative to traditional in vitro fertilization (IVF).
Key Benefits of Fertilo
Unlike conventional IVF methods that require 10-14 days of high-dose hormonal stimulation, Fertilo reduces the need for hormone injections by 80% and shortens treatment cycles to just 2-3 days. This not only provides a more comfortable experience for patients but also minimizes the risk of ovarian hyperstimulation syndrome and other side effects associated with high-dose hormone treatments.
Phase 3 Trial Details
The Phase 3 trial will be conducted across 15 sites in the United States and will evaluate the efficacy and safety of Fertilo in maturing healthy eggs outside the body, yielding viable embryos, and improving pregnancy rates. The primary efficacy endpoint will be the pregnancy rate assessed at 12 weeks of pregnancy. Secondary endpoints include embryo development, maternal health, and live birth rates.
The trial will enroll couples struggling with infertility for at least one year. Participants will undergo up to two days of hormonal injection stimulation, with up to two embryo transfers. A voucher for a second attempt will be offered to those who do not achieve pregnancy during the trial. The study will be a double-blind, randomized controlled trial to ensure rigorous data collection and analysis.
Expert Perspectives
Dina Radenkovic, CEO and Co-Founder of Gameto, stated, "FDA clearance to advance Fertilo into a Phase 3 trial is a significant milestone for Gameto, and a landmark moment in iPSC technology. We are proud to be pioneers in this field, with technology that has the potential to transform reproductive medicine."
Christian Kramme, Chief Scientific Officer of Gameto, added, "Gameto’s technology platform opens entirely new possibilities for addressing reproductive health challenges through cell engineering-inspired innovation. With Fertilo, we’ve demonstrated the potential of iPSC-based therapies to redefine fertility care by targeting ovarian health at the cellular level."
Fertilo's Impact and Future Directions
Fertilo builds upon the Nobel Prize-winning discovery of induced pluripotent stem cells by Japanese researcher Shinya Yamanaka. Gameto's technology has already achieved a historic milestone with the world's first live human birth using Fertilo in December 2024 at Santa Isabel Clinic in Lima, Peru.
Gameto is actively expanding the availability of Fertilo and has secured regulatory clearance in Australia, Japan, Argentina, Paraguay, Mexico, and Peru. The company has also formed a strategic partnership with IVFAustralia, part of the Virtus Health group, to broaden patient access to Fertilo.
With the Phase 3 trial underway, Fertilo represents a significant step forward in addressing infertility and improving outcomes for individuals and couples seeking to start a family. The potential of iPSC-based therapies to transform reproductive medicine is becoming increasingly evident, offering hope for a future with shorter, safer, and more accessible fertility treatments.
