Celmatix identifies leads in oral fertility drug program

Reproductive longevity company Celmatix announced it has identified “promising early leads” in its work to develop the world’s first oral FSH receptor (FSHR) agonist drug, which could revolutionize fertility treatments.

Infertility rates are increasing, with nearly 1 in 5 married women in the United States (ages 18-49) experiencing infertility and 1 in 4 women in this group having difficulty carrying a pregnancy to term. However, there has been little innovation in bringing new fertility drugs to the market. To address this, Celmatix has developed a proprietary multi-omic ovarian health platform to help discover new therapies.

“Our goal is to eliminate the need for injections during ovarian stimulation ahead of egg freezing and IVF procedures,” said Dr Piraye Yurttas Beim, 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 program to help men increase their sperm count and viability.”

On average, women undergo 60 injections across two treatment cycles to generate enough viable eggs to achieve a pregnancy. Injectable fertility drugs generate an estimated $5 billion dollars of sales for the pharmaceutical industry globally.

“The burden of infertility treatment… disproportionately and unfairly falls on women,” said Beim. “We also know that many women undergo IVF because current methods of improving ovulation for conditions like PCOS have low success rates. We knew that a simple pill that could eliminate injections from fertility treatments and provide alternatives to IVF would be a game changer.”

Celmatix’s drug program benefits from recent advancements in AI and computational methods for drug design. The company has made progress in developing oral FSHR agonists, overcoming the challenge of stimulating the FSH receptor without stimulating the thyroid hormone receptor. Early data suggests that Celmatix’s compounds successfully address this hurdle.

“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,” said Dr Stephen Palmer, Chief Scientific Officer of Celmatix. “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 optimization, we are hopeful to be on track to initiating clinical studies by 2025.”

In addition to its oral FSH program, Celmatix has collaborations with industry leaders for an AMHR2 agonist program focused on ovarian aging and a novel melatonin agonist program for PCOS.