In what could mark a significant shift in fertility treatment, Celmatix has announced the nomination of its first lead compound in its oral Follicle Stimulating Hormone receptor (FSHR) agonist drug development program. The breakthrough, announced during the American Society for Reproductive Medicine (ASRM) annual meeting in Denver, could potentially transform fertility treatments by replacing traditional hormone injections with oral medications.
The development comes just one year after identifying early leads for the oral FSH program. The compound has demonstrated both oral bioavailability and biological activity in the standard rodent model historically used to develop injectable FSH drugs. While rodent ovaries differ from human ovaries, these models have proven reliable for decades in developing ovarian stimulation drugs used in fertility treatments.
The innovation is particularly significant given the World Health Organization’s statistics showing that 1 in 6 people globally are affected by infertility, yet there has been minimal innovation in novel fertility drugs in recent decades.
“We are thrilled to see that our Lead compound not only demonstrates biological activity through an oral route of administration but also specifically targets the FSH receptor without affecting the closely related thyroid hormone receptor (TSHR),” said Dr. Stephen Palmer, Chief Scientific Officer of Celmatix. “Toxicity from off-target effects on TSHR have been a key challenge for prior drug development efforts to replace injectable fertility drugs that rely on the FSH hormone with small molecules. FSH evolved over millennia to have a 500 fold higher affinity for its receptor than TSHR. We are proud to report that our novel compounds demonstrate specificity for FSHR that is superior to that of FSH, which gives us optimism that our program will succeed where others have failed in past efforts.”
The development could have far-reaching implications beyond female fertility. Male infertility, which accounts for over 20% of infertility cases, could also benefit from this innovation. While injectable FSH medications have been used in European countries to treat male partners, adherence to injection regimens has been a significant challenge. An oral alternative could improve both compliance and efficacy.
The program also aims to address the limitations of existing ovulation induction treatments for women with conditions like PCOS, where current success rates are as low as 5% per cycle. Celmatix aims to improve these rates to 20-25%.
“Our oral FSH program stands to fundamentally change the landscape of fertility treatments. By offering a non-invasive alternative to daily injections, we aim to make fertility care more safe, accessible, and effective for both women and men,” said Dr. Piraye Yurttas Beim, Founder and CEO of Celmatix. “Our focus at Celmatix is on creating treatments that restore physiological balance and enhance overall patient safety and experience. Undergoing fertility treatment is already hard enough on people’s bodies. Why add the extra burden of having to self-administer dozens of injections when you could take a pill instead?”
This milestone represents another step forward in Celmatix’s growing pipeline of innovative drug programs, which also includes an AMHR2 agonist program focused on ovarian aging. The company’s approach is grounded in its proprietary multi-omic ovarian health platform, reportedly the world’s largest of its kind.
