预约演示
New medications for PCOS slowly edge toward development
2023-03-23
临床2期临床3期
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.
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 BioCOVID-19 pandemicdustry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
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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 mPCOSationshyperandrogenismovulatory dysfunctionpolycystic ovariesSpruce Biosciencesendocrine disorders
With limited research comes the perception that for decades, the pharmaceutical armamentarium for PCOS has been restricted to a hinsulin resistance (IR)s.metabolic syndrome (MS)s, and other drugs like clomiphene, eflornithine have been non-alcoholic fatty liver diseaseAs 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 tPCOSarent company of Pharmaceutical Technology.
Standard medications used for the disorder have also raised questions over their ability to meet tPCOSondition’s heterogeneous nature. “There is definitely an unmet need… When you talk to PCOS patientsclomipheneapeflornithinee don’t fully address their disease,” details Szwarcberg.PCOSmetformin
While the number of new investigatioPharmaceutical Technologyy 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 hyperandrogenisPCOSOH), 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 IPCOSudy (NCT05370521) in participants ages 18–40 years with PCOS and elevated adrenal androgens. The studExeltis Pharmaceuticalsated for release in mid-2023.dienogestsynthetic progesteroneethinylestradiolsynthetic estrogen
The idea that high adrenal androgen levels in women with Phyperandrogenemia rirregular menstruationin corinfertility(ACTH), a hormone released by the pitufunctional ovarian hyperandrogenism (FOH)is space. Using tildacerfont, which also acts as a modulatoPCOS ACTH rtildacerfontce aims to determine if PCOSlating the amount of ACTH regulatesprimary functional adrenal hyperandrogenism (FAH)ontext 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.androgen receptors
Sprucetional therapies don’t often address the managementildacerfontdrogenemia in the context of PCOS patients, says Szwarcberg. “We believe PCOS 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-gluctildacerfontt protein 2 (SGLT2) inhibitors, saysACTHeed Akhtar, PhD, assistant professor, Department of Clinical PhACTHcy at King Khalid University, Abha, Saudi Arabia. A research study fPCOS that Novartis’s aromatase inhibitor Femara (letrozole) currently appears to bcystic acnecthirsutismclmale-type baldnessa menstrual irregularitiesn treating infertilianovulationy infertilityncidence of infertility in women with this condition varies between 70–80%, research has found.
Managing PCOS symptomshyperandrogenemiaPCOShyperandrogenemia
The heterogeneous nature of metabolic and endocrine disorPCOS is a key factor influenciinsulin sensitizersr’s abglucagon-like peptide-1(GLP-1) agonistsglucagon-like peptide-1(GLP-1)ecific guiddipeptidyl peptidase-4 (DPP-4) inhibitorsdipeptidyl peptidase-4 (DPP-4)cational 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 rKing Khalid Universityheir uterine health.NovartisaromataseFemara (letrozole)clomiphene citrateinfertilityPCOSinfertility
Global hePCOScare 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. “[Pmetabolic and endocrine disordersdress and I don’t see many companies investing time in finding more advanced treatments for PCOS patients,” saPCOSzwarcberg. 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 caPCOSfor support. Rather, it expressed the importance of increasing awareness and opening an important dialogue on PCOS.
How is the Biopharmaceutical industry PCOSving?endometriosisPCOS
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:COVID-19 pandemic
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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