Anovulation

Therapeutic program targets a novel mechanism of melatonin receptor action outside of the CNS NEW YORK--(BUSINESS WIRE)-- Celmatix, Inc., the leading women’s health biotech focused on ovarian biology, today announced its latest drug program, which is targeting melatonin receptors outside of the central nervous system (CNS). The therapeutic drug will address a critical gap in the market for effective first-line treatments for a range of women’s health indications, starting with Polycystic Ovary Syndrome (PCOS) and with the potential to expand into the treatment of endometriosis and menopausal symptoms. PCOS is known primarily for being one of the most common causes of female infertility, affecting around 15% of women of reproductive age. However, disrupted ovarian physiology in women experiencing PCOS has also been shown to impact endocrine, immune, metabolic, cardiovascular, and mental health functions. Despite its prevalence, no drug has ever been developed specifically to treat PCOS. The existing standard of care for PCOS focuses on symptom management, including birth control pills to regularize periods, metformin to address insulin resistance, statins to control high cholesterol, ovarian stimulation for ovulatory dysfunction, and cosmetic procedures to remove unwanted hair. The Celmatix program is aimed at restoring ovarian function in a way that addresses the root cause of all these symptoms. The novel program has emerged from a decade-long multi-omics initiative at the Company to understand the molecular and genetic mechanisms underlying ovarian health and conditions like PCOS. Celmatix recently announced findings for which they accepted an award at the 2023 Society for Reproductive Investigation (SRI) meeting in Brisbane, Australia, demonstrating rare functional mutations in the melatonin receptor genes of women with PCOS and the strong association of the melatonin receptor genes with PCOS traits through algorithmic ranking approaches. Melatonin is a naturally occurring hormone that functions in the central nervous system (CNS), where it regulates the circadian rhythm. Increasing evidence has revealed an additional mechanism for melatonin signaling outside of the CNS, in peripheral tissues (including the ovary). A number of preclinical studies have validated the mechanism of melatonin receptor signaling outside of the CNS and independent studies and clinical trials have demonstrated that melatonin supplements can improve endocrine, metabolic and reproductive traits in women with PCOS and other women’s health conditions, including menopausal symptoms. However, the therapeutic effect from melatonin supplements is small before women develop significant side effects, including drowsiness due to the CNS-activity. Melatonin supplements also have low bioavailability and half-life in the body. Selective melatonin receptor agonists have been developed, however, these compounds were developed as sleep aids and therefore they are potently active in the CNS. The Celmatix therapeutic program is focused on developing a novel melatonin receptor agonist compound with peripherally-preferred pharmacokinetics to increase therapeutic action at the target tissues, including the ovary, and minimize unwanted side effects like drowsiness. Dr. Piraye Yurttas Beim, Celmatix founder and CEO commented, “The ovary is not just an egg factory. It is the central command center of a woman’s body, integrating signals from the body including stress, inflammation, and nutritional status. Light is one of the most powerful signals that enters our body, so it was no surprise to us that genetic differences in how women’s bodies respond to light emerged in our studies as a powerful link to PCOS and PCOS-related traits. We are excited to not just be at the forefront of highlighting the importance of melatonin signaling for ovarian health and function but also pioneering the development of a novel melatonin receptor agonist that acts specifically in the periphery and not the brain. We believe this drug has the potential to support ovarian health throughout a woman's lifespan, beginning with treating the root causes of PCOS early in life and later through enabling healthier aging for women as their ovarian function declines through the menopause transition.” Celmatix has previously announced its lead AMHR2 agonist program, aimed at delaying menopause. About Celmatix Celmatix Inc. is a preclinical-stage women’s health biotech focused uniquely on ovarian biology. With a lead “pipeline-in-a-pill” AMHR2 agonist program focused on ovarian senescence, and collaborations with industry leaders, Celmatix is addressing areas of high unmet need by developing the next generation of interventions and pioneering advancements in ovarian health. Celmatix’s proprietary multi-omic ovarian health platform, the world’s largest of its kind, is the foundation of the company’s novel pipeline of first-in-class therapies. For more information, visit the company’s website at

Credit: Shutterstock/justesfir Polycystic ovarian syndrome (PCOS), sometimes known as polycystic ovarian disease (PCOD), is a common endocrine disorder experienced by approximately 5 to 13% of people of reproductive age worldwide. While lifestyle modifications play a key role in treating PCOS, the paucity of new treatments signal a need for breakthrough research. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Visit our privacy policy for more information about our services, how we may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. Research states that PCOS is typically characterized by hyperandrogenism, high levels of androgens; ovulatory dysfunction; and polycystic ovaries. Scientific research and a better understanding of the condition is driving new developments in medications. ”The condition’s symptoms are not homogeneous, and that makes drug development complicated,” Javier Szwarcberg, CEO of Spruce Biosciences, a rare disease company researching endocrine disorders, says. A growing body of research also highlights the condition’s impact on quality of life and mental wellbeing. It is associated with insulin resistance (IR), metabolic syndrome (MS), low-grade chronic inflammation, and an increased risk of non-alcoholic fatty liver disease. Unmet need for PCOS medications With limited research comes the perception that for decades, the pharmaceutical armamentarium for PCOS has been restricted to a handful of standard drugs. Hormonal contraceptives, and other drugs like clomiphene, eflornithine have been reported to ameliorate symptoms. As per GlobalData, practitioners typically turn to five drugs to treat PCOS ; the main drug is metformin, accounting for almost a quarter of trials (24.7%). GlobalData is the parent company of Pharmaceutical Technology. Standard medications used for the disorder have also raised questions over their ability to meet the condition’s heterogeneous nature. “There is definitely an unmet need… When you talk to PCOS patients, the therapies they take don’t fully address their disease,” details Szwarcberg. While the number of new investigational therapies specifically designed to treat PCOS is scant, some companies continue to repurpose hormonal medications. Florham Park, New Jersey-based Exeltis Pharmaceuticals is currently running a Phase III study (EudraCT-2021-002178-17) with LPRI-421, a fixed dose combination of dienogest, a synthetic progesterone, and ethinylestradiol, a synthetic estrogen. Current treatment options mainly address symptoms such as hyperandrogenemia, irregular menstruation, and infertility, and therefore support patients with functional ovarian hyperandrogenism (FOH), which is estimated to affect around 62% of patients with PCOS. With tildacerfont, Spruce aims to target PCOS patients with mixed pathology and primary functional adrenal hyperandrogenism (FAH), which are collectively experienced by approximately 30% of patients  who have exaggerated  levels of dehydroepiandrosterone sulphate (DHEAS), a type of androgen. A 2019 study has revealed that androgens play a key role in regulating female fertility and androgen receptors are prevalent in the origins of the condition. Spruce is currently studying the safety and efficacy of tildacerfont in a Phase II study (NCT05370521) in participants ages 18–40 years with PCOS and elevated adrenal androgens. The study’s results are anticipated for release in mid-2023. The idea that high adrenal androgen levels in women with PCOS could also be related to an increase in corticotropin (ACTH), a hormone released by the pituitary gland, has long been explored in this space. Using tildacerfont, which also acts as a modulator of ACTH release, Spruce aims to determine if modulating the amount of ACTH regulates the amount of adrenal androgens present in the context of PCOS. Research indicates that increased adrenal androgen production can result in cystic acne, hirsutism, male-type baldness, menstrual irregularities, oligoovulation or anovulation, infertility, and/or frank virilization. Conventional therapies don’t often address the management of hyperandrogenemia in the context of PCOS patients, says Szwarcberg. “We believe this study will provide information around biology and create the foundations by which a program can then be built around the potential benefits in hyperandrogenemia control.” Other novel therapeutic modalities for the management of PCOS include the use of newer insulin sensitizers viz, glucagon-like peptide-1(GLP-1) agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors, and sodium-glucose transport protein 2 (SGLT2) inhibitors, says Sayeed Akhtar, PhD, assistant professor, Department of Clinical Pharmacy at King Khalid University, Abha, Saudi Arabia. A research study found that Novartis’s aromatase inhibitor Femara (letrozole) currently appears to be more effective than clomiphene citrate, a common reference drug, in treating infertility caused by PCOS. The incidence of infertility in women with this condition varies between 70–80%, research has found. Managing PCOS symptoms The heterogeneous nature of metabolic and endocrine disorders is a key factor influencing the health sector’s ability to advise and provide specific guidance for managing PCOS. US educational platform Uterinekind has teamed up with the Cornell Ovary Lab to fund research on the condition and has developed an app to help people access resources and support their uterine health. Global healthcare better supports patients in managing their symptoms by “managing the different facets of issues developed due to PCOS”, says Akhtar. Making lifestyle changes is often the first line of treatment before the addition of an insulin-sensitizing drug may be advised. More research is needed. “[PCOS] is a difficult disease to address and I don’t see many companies investing time in finding more advanced treatments for PCOS patients,” says Szwarcberg. Commenting on why there is so little research despite the high incidence, Akhtar says this is due to “less focus on policy and funding”. A 2021 UK parliamentary discussion on PCOS and endometriosis stated it did not have plans to increase near-term funding, despite calls for support . Rather, it expressed the importance of increasing awareness and opening an important dialogue on PCOS. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Women with polycystic ovary syndrome (PCOS) in Alabama may be more likely to have excessive hair growth and insulin resistance, whereas women with PCOS in California may be more likely to have higher testosterone levels, according to new research. Women with polycystic ovary syndrome (PCOS) in Alabama may be more likely to have excessive hair growth and insulin resistance, whereas women with PCOS in California may be more likely to have higher testosterone levels, according to new research published in the Endocrine Society's Journal of Clinical Endocrinology & Metabolism. PCOS affects 7-10% of women of childbearing age and is the most common cause of infertility. In the United States, an estimated 5 to 6 million women have PCOS, but the disorder is still underdiagnosed. Women are diagnosed with PCOS if they have two of the following criteria: androgen excess (excess male sex hormones such as testosterone), ovulatory dysfunction and polycystic ovaries. "Our study found geographical differences in PCOS in black and white women, suggesting there are both genetic and environmental influences on how this disease manifests," said Margareta D. Pisarska, M.D., of Cedars-Sinai in Los Angeles, Calif. "Ongoing research is needed to identify modifiable risk factors for PCOS that may be race and ethnicity-specific to bring precision medicine to the management of this disease." The researchers compared data from 1,610 black and white women with PCOS in Alabama and California. They found regional differences in the way these women met criteria for the diagnosis of PCOS and in symptoms associated with PCOS, with some variations among black and white women. Overall, there were many similarities among the races. Women with PCOS in Alabama were more likely to have excessive hair growth and insulin resistance, whereas women with PCOS in California were more likely to have higher levels of testosterone. When comparing black women with PCOS in Alabama and California, the average body mass index (BMI) did not differ between the locations, whereas in white women with PCOS, the average BMI was higher in Alabama than California. "Since we have now identified that there are geo-epidemiologic differences, we intend to do follow up studies comparing black and white women with PCOS, controlling for geo-epidemiologic differences," Pisarska said. "Furthermore, we are trying to look at factors that are contributing to these differences in order to tailor treatments based on specific needs for improvements in care for all women with PCOS." Other authors of this study include Katherine VanHise, Jessica L. Chan, Sahar Wertheimer, Roy G. Handelsman, Ekaterina Clark, Rae Buttle and Erica T. Wang of Cedars-Sinai Medical Center; and Ricardo Azziz of the University of Alabama at Birmingham in Birmingham, Ala. and the University of Albany, SUNY, in Albany, N.Y. The study received funding from the National Institutes of Health and Helping Hand of Los Angeles, Inc.