Start-up makes breakthrough in oral fertility drug programme

The women’s health biotech company Celmatix has identified “promising” early leads in its latest fertility drug programme.

Celmatix’s goal is to substitute follicle stimulating hormone (FSH) injections, commonly used in IVF and egg freezing protocols, with an oral alternative.

The preclinical-stage company aims to make ovulation induction more efficient, specifically for women with conditions like PCOS, while also addressing the “significant burden” of male infertility.

“Our goal is to eliminate the need for injections during ovarian stimulation ahead of egg freezing and IVF procedures,” explains Dr Piraye Yurttas Beim, founder and CEO of Celmatix.

“We also want to reduce the need for women to undergo IVF procedures in the first place, by both providing a more effective strategy for restoring ovulatory function in women with ovarian conditions like polycystic ovary syndrome (PCOS) and addressing the significant burden that male infertility places on couples by also advancing our programme to help men increase their sperm count and viability.

“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,” she continues.

“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.”

Women undergo, on average, 60 injections across two treatment cycles to generate enough viable eggs to achieve a pregnancy, with the global fertility drugs market expected to reach US$3.40bn by 2026.

“We have heard for over a decade from both women and their doctors about the high burden of hormone injections, which are required for these procedures,” adds Beim.

“Interestingly, 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.

“We know that many women undergo IVF because current methods of improving ovulation for conditions like PCOS have low success rates, but we also know that a simple pill that could eliminate injections from fertility treatments and provide alternatives to IVF would be a game changer.”

FSHR is a member of the G protein-coupled receptor (GPCR) family of proteins, which are among the most common class of targets for small, orally available therapeutic drugs.

One challenge to developing oral drugs targeting FSHR, Celmatix says, has been that it is closely related to the receptor for thyroid hormone. Therefore, a successful oral FSHR drug must stimulate the FSH receptor without stimulating the thyroid hormone receptor (TSHR).

Early Celmatix data suggests that its compounds overcome this significant hurdle to drug development for this target.

“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,” says Celmatix chief scientific officer, Dr Stephen Palmer.

“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.

“As we move these promising hits into lead optimisation, we are hopeful to be on track to initiating clinical studies by 2025.”