Polycystic Ovary Syndrome

Dr. Aly joins CCRM Fertility's leading team of fertility specialists at CCRM | IRMS in Jersey City JERSEY CITY, N.J., March 27, 2024 /PRNewswire/ -- CCRM Fertility, a leading pioneer in the fertility treatment, research, and science industry, announced today that Jasmine Aly, MD, FACOG, will be joining CCRM | IRMS in New Jersey. Dr. Aly holds the rare distinction of being a triple-specialized physician as an Obstetrician-Gynecologist, Reproductive Endocrinologist, and Medical Geneticist. As Regional Director of Clinical Reproductive Genetics, Dr. Aly will bring her expertise to the CCRM Fertility team and aims to leverage her comprehensive fellowship training in genetics to further advance the field and better serve patients. As an esteemed reproductive endocrinologist, she will utilize cutting-edge technology and innovative scientific techniques to ensure patient success rates continue to rise. "Dr. Aly's expertise in genetics is an invaluable attribute that will redefine care at CCRM | IRMS," notes CCRM Fertility CEO, Bob LaGalia. "Together, we'll continue to empower our patients with cutting-edge solutions and compassionate support." "In the dynamic realm of healthcare and the ever-evolving landscape of medical practice, my goal is to reorient the focus back towards patient-centered care. I hope to assist individuals navigating the complex domains of infertility and reproductive genetics," said Dr Aly. "My aim is for patients to leave my office feeling genuinely heard, understood, and empowered with a clear, personalized plan, guiding them confidently toward their path to parenthood." Dr. Aly earned her medical degree from the Robert Wood Johnson Medical School and completed her residency at the Cooper University Hospital where she received the honor of Resident of the Year and served as Chief Resident. She then went on to complete a Research Fellowship in advanced basic science techniques at the Uniformed Services University of the Health Sciences (USUHS). At USUHS, she focused her efforts on fibroids, culminating in the identification and publication of a novel tumor suppressor gene. She then completed a specialized fellowship in Reproductive Endocrinology and Infertility (REI) at the National Institute of Health (NIH) and Walter Reed National Military Medical Center (WRNMMC). This sparked her affinity for the convergence of genetics and infertility and propelled her towards an exclusive dual fellowship in Medical Genetics at the National Human Genome Research Institute (NHGRI). During this tenure, she earned simultaneous degrees in REI and Genetics and assumed the roles of co-investigator and site director for a U01 grant study, investigating the interplay between endometrial function, gene regulation, and their impact on recurrent implantation failure and recurrent pregnancy loss. Dr. Aly has committed her career to exploring critical disparities in reproductive healthcare, shedding light on crucial facets of inclusivity and equity in the field. This can be seen through her published work focused on disparities in Assisted Reproductive Technology (ART) outcomes, notably among African American and Latinx communities. Her publications also encompass studies on the intersection of Polycystic Ovary Syndrome (PCOS), obesity, and infertility, as well as the effects of COVID-19 on human reproduction. Her contributions can also be found in highly regarded peer-reviewed journals such as Reproductive Sciences, Endocrine Practice, and Clinical and Experimental Obstetrics and Gynecology. In recognition of her display of compassion toward patients and colleagues and her strong commitment to embodying the highest standards of empathy and humanistic care within the medical community, Dr. Aly was inducted into The Gold Humanism in Medicine Honor Society, an esteemed recognition conferred by peers. About CCRM Fertility CCRM Fertility is a global pioneer in fertility treatment, research, and science. Founded by Dr. William Schoolcraft more than 35 years ago, CCRM Fertility specializes in the most advanced fertility treatments, with deep expertise in IVF, fertility testing, egg freezing, preimplantation genetic testing, third party reproduction and egg donation. CCRM Fertility leverages its own data and a dedicated team of in-house reproductive endocrinologists, embryologists, and geneticists to deliver industry-leading outcomes. CCRM Fertility is a proud strategic partner of Unified Women's Healthcare, which is accelerating meaningful change in women's healthcare by building healthy, innovative, and mission-driven businesses to meet the comprehensive needs of women across the entirety of their health journey. For more information, visit . SOURCE CCRM Fertility

作者 | 颜色来源 | 赛柏蓝最新研究发现，二甲双胍可能带来更为安全可靠的减肥疗法。01二甲双胍或能带来可靠减肥疗法 近日，《自然》子刊Nature Metabolism发表了两篇最新研究揭示了二甲双胍减肥的新作用机制。Nature Metabolism发布了评论文章，指出探索二甲双胍的下游信号通路，可能带来更为安全可靠的减肥疗法。 研究发现，二甲双胍在肠道可以通过抑制表达CNDP2的肠道上皮细胞的电子传递链复合体I，提高乳酸流入细胞内的水平，从而刺激Lac-Phe的生成。科学家们搭建了二甲双胍减肥的完整信号通路，口服二甲双胍在肠道刺激表达CNDP2的肠道上皮细胞生成Lac-Phe，而Lac-Phe通过作用于脑肠轴抑制食欲，达到减肥效果。 值得一提的是，此前已经有研究表示，二甲双胍具有轻度减轻体重的作用。研究发现，中国新诊断2型糖尿病患者经二甲双胍单药治疗16周，体重正常、超重及肥胖患者的体重分别下降1.47、2.81及2.92kg。磺脲类、噻唑烷二酮类、胰岛素等降糖药物可增加体重，联合二甲双胍可减轻上述药物对体重增加的影响。 Nature Metabolism发表的文章评论，与GLP-1类药物相比，二甲双胍的减肥效果更为温和和缓慢。不过，上述文章指出，“靶向Lac-Phe下游通路的研究能否带来避免目前减肥药副作用的安全可靠疗法，让我们拭目以待。” 在疾病治疗领域，“二甲双胍”深入了多个赛道，作用不少。 《二甲双胍临床应用专家共识》（2023版）曾对二甲双胍的降糖和器官保护作用给出了肯定，其具有良好的疗效和安全性。不完全梳理发现，二甲双胍既往的潜质作用包括：抗衰老、逆转生物年龄、防雾霾、协助戒烟、抗炎、改善多囊卵巢综合征、心血管保护作用、改善肠道菌群等。 我国肥胖人数从2016年的1.8亿人增至2020年的2.2亿人，复合年增长率为5.0%。预计后续减肥需求将持续增加。 根据弗若斯特沙利文统计，2016-2020年，全球减肥药物市场规模由18亿美元增长至26亿美元；2016-2021年，中国减肥药物市场规模由2016年的2.6亿元增长至2021年的约30亿元。02减重市场火热国内外减重适应症药物PK目前在减重市场，国内外已经有不少药企入局，主要聚焦在GLP-1多肽类药物。 从国内的针对肥胖减重适应症的药物来看，已经上市的有华东医药的利拉鲁肽注射液（2023年7月4日获批上市）、仁会生物的贝那鲁肽（2023年7月27日获批上市）。目前提交国内上市申请的药物有诺和诺德的司美格鲁肽注射液和礼来的替尔泊肽等。 此前，在一次“资本市场日”活动上，诺和诺德透露，预计Wegovy今年将在中国获批上市，这款产品最开始将以自费选择为主，并且有数量限制。在减重领域，司美格鲁肽有着难以撼动的地位。作为诺和诺德的明星产品，2023年Wegovy的收入达到313.43亿丹麦克朗。 礼来的替尔泊肽被认为是司美格鲁肽“劲敌”，礼来在clinicaltrials.gov网站上登记了一项III期临床试验（SURMOUNT-5），评估替尔泊肽对比Wegovy（2.4mg）用于成人肥胖或超重且伴有体重相关合并症的非2型糖尿病患者的有效性与安全性。这是替尔泊肽减重适应症首次头对头司美格鲁肽的临床研究，该研究预计将于2024年11月完成。研究结果显示，72周治疗后，15mg替尔泊肽治疗平均减重20.9%，10mg剂量组平均减重19.5%，5mg剂量组平均减重15%磅，安慰剂组减重3.1%，三分之一的患者减重超过体重的四分之一。研究结果表明，超2600名患者接受长达68周的司美格鲁肽治疗，在第68周，司美格鲁肽治疗的患者体重减轻了12.4%，69%的患者体重减轻超过10%。 当前也有多款以GLP-1为靶点的新药正在国内开展针对肥胖和超重人群的3期临床研究，包括信达的玛仕度肽、先为达的伊诺格鲁肽注射液等。 此外，不少药物虽然还在临床阶段，但其减重研究结果已经引发关注。3月7日，诺和诺德在其举行的资本市场日活动上公布了新一代肥胖症治疗药物amycretin积极的临床I期数据。结果显示，amycretin具有总体良好的安全性和显著的减重效果。据其研发报告，服用amycretin12周后，受试者体重下降了13.1%，而安慰剂组在相同的时间跨度内体重仅下降了1.1%。 减肥药擂台上的竞争仍在持续，随着人们对健康生活的重视程度的提高，更多药企和产品还在挖掘自身的实力。END作者交流：One1-3058内容沟通：13810174402医药代表交流群扫描下方二维码加入银发经济市场机遇交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联

CAHmelia-203 Study of Tildacerfont in Adult Classic Congenital Adrenal Hyperplasia (CAH) with Severe Hyperandrogenemia Did Not Meet Primary Efficacy Endpoint Positive Data from CAHptain-205 Study of Tildacerfont in Pediatric Classic CAH Supports Further Dose-Ranging Across Additional Dosing Cohorts Topline Results from CAHmelia-204 Study of Tildacerfont in Adult Classic CAH Evaluating Glucocorticoid (GC) Reduction Anticipated in Third Quarter of 2024 Resource Prioritization and Cost Reductions Extend Cash Runway Through End of 2025 Conference Call Today at 4:30 p.m. ET SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need, today reported financial results for the year ended December 31, 2023 and provided corporate updates. “We are grateful to all the patients, families, study team and investigators who supported the CAHmelia-203 clinical trial,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer, Spruce Biosciences. “CAHmelia-203 is the first study of its kind to address a difficult-to-treat CAH patient population with severe and more refractory hyperandrogenemia, which is often attributed to challenging real-life compliance with daily GCs. We garnered important data from this study which will inform ongoing development of tildacerfont in adult classic CAH.” Dr. Szwarcberg added, “Looking ahead to the third quarter of 2024, we are eager to report topline results from CAHmelia-204, which is focused on assessing GC reduction, a potentially registrational endpoint, in a different population of adult CAH patients with relatively controlled A4 levels and historically better adherence to GC therapy. Assuming positive results from CAHmelia-204 and CAHptain-205, we plan to meet with the U.S. Food and Drug Administration (FDA) and comparable foreign regulatory authorities in early 2025 to outline the design of a registrational clinical program in adult and pediatric classic CAH. Finally, we have made the difficult but necessary decision to streamline our operations and implement cost reduction measures, which has extended our cash runway through the end of 2025. I want to thank all of our employees, including those departing Spruce, for their dedication to advancing our mission of bringing forward novel therapies for CAH and other rare endocrine disorders.” Recent Corporate Updates CAHmelia-203 Study of Tildacerfont in Adult Classic Congenital Adrenal Hyperplasia (CAH) with Severe Hyperandrogenemia Did Not Meet Primary Efficacy Endpoint. CAHmelia-203 enrolled 96 subjects with a mean baseline androstenedione (A4) level of 1,151 ng/dL, which is more than five times above the upper limit of normal (ULN). The clinical trial did not achieve the primary efficacy endpoint of the assessment of dose-response for the change in A4 from baseline to week 12. 200mg QD of tildacerfont demonstrated a placebo-adjusted reduction from baseline in A4 of -2.6% with a non-significant p-value at week 12. Compliance with study medication and glucocorticoid (GC) was low with only 50% of patients reporting 80% or greater compliance, resulting in lower-than-expected tildacerfont exposure. Tildacerfont was generally safe and well tolerated at all doses, with no treatment-related serious adverse events (SAEs). Most adverse events were reported as mild to moderate. Positive Data from CAHptain-205 Study of Tildacerfont in Pediatric Classic CAH Supports Further Dose-Ranging Across Additional Dosing Cohorts. CAHptain-205 enrolled 30 children between two and 17 years of age with a mean baseline GC dose of 14 mg/m2/day and mean baseline A4 level of 372 ng/dL. The study characterized the safety and pharmacokinetic profiles of tildacerfont, as well as changes in androgen levels over 12 weeks of treatment, and the ability to reduce daily GC dose upon A4 normalization. Tildacerfont was generally safe and well tolerated at all dose ranges with no treatment-related SAEs reported. Preliminary pharmacokinetic analysis suggests that tildacerfont is cleared more rapidly in children than in adult CAH patients. 73% of all patients (22 of 30 patients) met the efficacy endpoint of A4 or GC reduction from baseline at 12 weeks of treatment with tildacerfont. 70% of patients with elevated baseline A4 values (16 of 23 patients) demonstrated an A4 reduction at week 4. Anticipated Upcoming Milestones Topline results from the CAHmelia-204 clinical trial in adult classic CAH patients on supraphysiologic doses of glucocorticoids with normal or near normal levels of A4 in the third quarter of 2024 Topline results from additional dose-ranging in the Phase 2 CAHptain clinical trial in the fourth quarter of 2024 End of Phase 2 (EOP2) meeting with the U.S. FDA in the first quarter of 2025 Full Year 2023 Financial Results Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2023 were $96.3 million. The company currently has over $81 million in cash and cash equivalents. Resource prioritization and cost reductions, including termination of the CAHmelia-203 clinical trial and a reduction in force of approximately 21%, extend cash runway through the end of 2025, including beyond anticipated topline results from CAHmelia-204 and additional dose-ranging data from CAHptain-205. Collaboration Revenue: Collaboration revenue for the year ended December 31, 2023 was $10.1 million compared to nil in 2022, reflecting the partial recognition of the $15.0 million upfront payment received from Kaken Pharmaceutical (“Kaken”) in connection with the company’s strategic collaboration with Kaken to develop and commercialize tildacerfont for the treatment of classic CAH in Japan. Research and Development (R&D) Expenses: R&D expenses for the year ended December 31, 2023 were $49.4 million compared to $35.2 million in 2022. The overall increase in R&D expenses was primarily related to progressing clinical development of tildacerfont in adult classic CAH, pediatric classic CAH and polycystic ovary syndrome (PCOS). General and Administrative (G&A) Expenses: G&A expenses for the year ended December 31, 2023 were $12.7 million compared to $12.1 million in 2022. Total Operating Expenses: Total operating expenses for the year ended December 31, 2023 were $62.1 million compared to $47.3 million in 2022. Non-cash stock-based compensation expense for the year ended December 31, 2023 was $4.6 million compared to $3.6 million in 2022. Net Loss: Net loss for the year ended December 31, 2023 was $47.9 million compared to $46.2 million in 2022. Conference Call Details Spruce’s management team and key study investigators will host a conference call today at 4:30 p.m. ET to discuss the topline results of the CAHmelia-203 and CAHptain-205 clinical studies. Analysts and investors can participate in the conference call by registering here or dialing (866) 777-2509. An archived copy of the call will be available on the events section of the company’s investor relations website for approximately 90 days. About Spruce Biosciences Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need. Spruce is initially developing its wholly-owned product candidate, tildacerfont, as the potential first non-steroidal, once-daily therapy for patients suffering from classic congenital adrenal hyperplasia (CAH) and other endocrine disorders. To learn more, visit and follow us on X, LinkedIn, Facebook, and YouTube. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the design, results, conduct, progress and timing of Spruce’s clinical trials; tildacerfont’s potential to be a novel treatment option that improves long-term health outcomes for patients with CAH; Spruce’s expectations regarding reporting results of its clinical trials in 2024; Spruce’s plans to meet with the FDA and comparable foreign regulatory authorities to discuss the potential registrational path forward of tildacerfont for adult and pediatric classic CAH; the impact of cost savings initiatives and the length of Spruce’s anticipated cash runway; and Spruce’s product candidate, strategy and regulatory matters. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate”, “will”, “potential”, “plan” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Spruce’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Spruce’s business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Spruce’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Spruce undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. SPRUCE BIOSCIENCES, INC. BALANCE SHEETS (in thousands, except share and per share amounts) December 31, 2023 2022 ASSETS Current assets: Cash and cash equivalents $ 96,339 $ 24,487 Short-term investments — 54,590 Prepaid expenses 3,876 3,320 Other current assets 1,968 1,211 Total current assets 102,183 83,608 Right-of-use assets 1,181 1,400 Other assets 582 640 Total assets $ 103,946 $ 85,648 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 3,332 $ 1,426 Accrued expenses and other current liabilities 14,600 9,399 Term loan, current portion 1,622 1,622 Deferred revenue 4,911 — Total current liabilities 24,465 12,447 Lease liabilities, net of current portion 1,019 1,261 Term loan, net of current portion 1,717 3,293 Other liabilities 236 161 Total liabilities 27,437 17,162 Commitments and contingencies Stockholders’ equity: Preferred stock, $0.0001 par value; 10,000,000 shares authorized and no shares issued or outstanding as of December 31, 2023 and 2022 — — Common stock, $0.0001 par value; 200,000,000 shares authorized as of December 31, 2023 and 2022; 41,029,832 and 23,601,004 shares issued and outstanding as of December 31, 2023 and 2022, respectively 4 3 Additional paid-in capital 273,737 218,354 Accumulated other comprehensive loss — (558 ) Accumulated deficit (197,232 ) (149,313 ) Total stockholders’ equity 76,509 68,486 Total liabilities and stockholders’ equity $ 103,946 $ 85,648 SPRUCE BIOSCIENCES, INC. STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share amounts) Year Ended December 31, 2023 2022 Collaboration revenue $ 10,089 $ — Operating expenses: Research and development 49,432 35,198 General and administrative 12,650 12,085 Total operating expenses 62,082 47,283 Loss from operations (51,993 ) (47,283 ) Interest expense (483 ) (420 ) Interest and other income, net 4,557 1,523 Net loss (47,919 ) (46,180 ) Other comprehensive gain (loss), net of tax: Unrealized gain (loss) on available for sale securities 558 (374 ) Total comprehensive loss $ (47,361 ) $ (46,554 ) Net loss per share, basic and diluted $ (1.24 ) $ (1.96 ) Weighted-average shares of common stock outstanding, basic and diluted 38,510,220 23,527,116