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Celmatix Advances Oral FSHR Agonist for Fertility Treatment

• Celmatix has nominated its first lead compound in its oral Follicle Stimulating Hormone receptor (FSHR) agonist drug development program, potentially replacing traditional hormone injections. • The oral FSH program compound has demonstrated oral bioavailability and biological activity in rodent models, showing specificity for FSHR superior to FSH itself. • This innovation could benefit both female and male infertility, offering a non-invasive alternative to daily injections and improving compliance and efficacy. • Celmatix aims to improve ovulation induction treatment success rates for women with conditions like PCOS from the current 5% per cycle to 20-25%.

Celmatix has announced the nomination of its first lead compound in its oral Follicle Stimulating Hormone receptor (FSHR) agonist drug development program, marking a potential shift in fertility treatment. The announcement, made during the American Society for Reproductive Medicine (ASRM) annual meeting in Denver, highlights the possibility of replacing traditional hormone injections with oral medications.

Oral FSHR Agonist Shows Promise

The development comes one year after identifying early leads for the oral FSH program. The compound has demonstrated both oral bioavailability and biological activity in rodent models, which have historically been reliable for developing ovarian stimulation drugs. According to Dr. Stephen Palmer, Chief Scientific Officer of Celmatix, the lead compound specifically targets the FSH receptor without affecting the closely related thyroid hormone receptor (TSHR). This specificity is crucial, as off-target effects on TSHR have been a key challenge in previous attempts to replace injectable fertility drugs.

Addressing Infertility with Innovation

The innovation is particularly significant considering the World Health Organization’s statistics, which indicate that 1 in 6 people globally are affected by infertility. Despite this widespread issue, there has been minimal innovation in novel fertility drugs in recent decades. Celmatix aims to address this gap by offering a non-invasive alternative to daily injections, potentially making fertility care more accessible and effective.

Potential Benefits for Male Infertility and PCOS

The development could have implications beyond female fertility, potentially benefiting male infertility, which accounts for over 20% of infertility cases. Injectable FSH medications have been used in European countries to treat male partners, but adherence to injection regimens has been a challenge. An oral alternative could improve both compliance and efficacy. Furthermore, the program aims to improve 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%.

Celmatix's Broader Pipeline

According to Dr. Piraye Yurttas Beim, Founder and CEO of Celmatix, the oral FSH program stands to fundamentally change the landscape of fertility treatments. 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.
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Reference News

[1]
Celmatix Achieves Milestone in Development of Oral Fertility Drug - Femtech Insider
femtechinsider.com · Oct 22, 2024

Celmatix announces its first lead compound in oral FSHR agonist drug development, potentially replacing traditional horm...

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