On average, women undergoing in vitro fertilization (IVF) have up to 60 shots across two treatment cycles. With IVF coming at a hefty price tag — the standard cost for one cycle is over $12,000 — people who feel squeamish or uncomfortable around needles had no choice but to deal with it. Now, a new fertility drug is soon going to upend how we treat infertility.

Celmatix, the leading women’s health biotech focused uniquely on ovarian biology, has reported early leads in its development of the world’s first oral fertility drug. The project aims at developing a follicle stimulating hormone receptor (FSHR) agonist drug delivered in pill form that could one day replace injections used in IVF and egg freezing protocols. 

“Hormone injections for treating infertility date back to studies first performed literally 100 years ago, at a time when the average life expectancy for a woman in the US was just 48,” explains Flow Advisory Council member Dr. Piraye Yurttas Beim, founder and CEO of Celmatix, in a recent press release. “Now that women are living into their 80s, they naturally want to start and expand their families much later in their lives. That means that more women are proactively seeking egg freezing but also are increasingly relying on fertility treatments, including IVF, to get pregnant.”

Adding another treatment option will help with addressing a rising infertility crisis in the United States. About 19 percent of married women between the ages of 15 to 49 experience infertility after one year of trying. One in four in this group has trouble getting pregnant or carrying a full-term pregnancy. Infertility treatments are often paid out of pocket and this nearly 4 billion dollar pharmaceutical industry has done little to improve their injectable hormone drugs.

Beyond reducing the need for IVF, the pill has the potential to improve the success of ovulation induction (the process of stimulating egg development and release) in women with polycystic ovary syndrome (PCOS) who have a high rate of infertility. The ease of taking a pill also places the burden of infertility treatment back on men. 

“The same hormone injections could be used to improve sperm quality in men and avoid IVF altogether for many couples with infertility; however, men have rejected the idea of undergoing months of painful injections. The burden of infertility treatment, therefore, disproportionately and unfairly falls on women,” Dr. Beim explains. As the program advances, the pill shows potential in treating male infertility by increasing sperm count and viability.

FSHR is a part of the G-protein-coupled receptor family of proteins. They are the most common class of targets for small, oral drugs. One challenge with creating a pill is that the FSH receptor closely resembles the thyroid hormone receptor. A successful drug would activate the FSH receptor while avoiding the thyroid receptor hormone. With recent advancements in AI technology in drug design and decades of medical research, early data from Celmatix looks promising in overcoming the challenge of targeting the right receptor.

“We are very pleased to see that several of our novel compounds demonstrate the desired potency and selectivity required for a successful oral FSH drug. Furthermore, several of these early leads also demonstrate solubility and metabolic stability that are a 20-fold improvement compared to previously reported FSHR small molecule ligands,” says Celmatix Chief Scientific Officer Dr. Stephen Palmer.