Sparrow Pharmaceuticals, Inc.

PORTLAND, Ore.--( BUSINESS WIRE )-- Sparrow Pharmaceuticals today announced that it presented new data from its ongoing Phase 2 clinical trial of its HSD-1 inhibitor, clofutriben (referred to SPI-62 in the study), in combination with prednisolone for the treatment of polymyalgia rheumatica (PMR) at the German Congress of Rheumatology (DGRh Kongress 2024) in Dusseldorf, Germany on 18 – 21 September, 2024. The data was presented in an oral presentation that took place on Thursday, September 19 th at 3:25PM CEST and a poster session. David Katz, PhD, Chief Scientific Officer at Sparrow discussed the abstract titled “ An 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibitor to Optimize the Effects of Prednisolone in Patients with Polymyalgia Rheumatica (PMR) .” Key findings were highlighted from the trial, which investigated the potential of clofutriben to reduce or prevent side effects of prednisolone while maintaining its effectiveness in PMR patients. The trial included 40 participants with confirmed PMR who were given prednisolone 10 mg, 15 mg, or 20 mg together with clofutriben 6 mg for 2 weeks. Patients also were given prednisolone 10 mg with placebo for clofutriben for 2 weeks. Result highlights are: No PMR relapses occurred when prednisolone 15 mg or 20 mg was co-administered with clofutriben. A combination of prednisolone 20 mg with clofutriben showed similar efficacy as prednisolone 10 mg with placebo, based on analysis of participants’ symptoms, physical function, and biomarkers of inflammation. All prednisolone doses in combination with clofutriben showed less glucocorticoid toxicity compared to prednisolone with placebo. "The data suggest that by using an HSD-1 inhibitor like clofutriben, we may be able to improve the balance between the therapeutic benefits and side effects of glucocorticoid therapy in patients with PMR," said Dr. Katz. "These encouraging findings support Sparrow’s innovative approach to develop treatments that may spare patients from the negative effects of glucocorticoid use, while maintaining the therapeutic benefits. This could potentially offer a new treatment paradigm for patients with rheumatic diseases and the many other conditions treated with glucocorticoids." Additionally, Sparrow has expanded its PROST! Phase 2 clinical trial ( NCT05436652 ) with a fifth cohort to explore clofutriben in combination with prednisolone for the treatment of PMR. This will allow for the continued study of how clofutriben can maintain the efficacy of steroid medicines without the harsh side effects. To learn more about Sparrow Pharmaceuticals and clofutriben (SPI-62), visit www.sparrowpharma.com . About Sparrow Pharmaceuticals Sparrow Pharmaceuticals was founded to spare patients the ravages of steroids. Leveraging underappreciated scientific insights into glucocorticoid biology, the company is working to provide better treatment options for serious disorders of hypercortisolism, and to revolutionize the treatment of autoimmune and inflammatory conditions. Its lead product, clofutriben (SPI-62), is an oral, small molecule, novel therapeutic treatment designed to target a source of active intracellular glucocorticoids in key tissues.

According to DelveInsight's estimates, the increasing prevalence of diabetes, obesity, hormonal disorders, socioeconomic factors, changes in sedentary lifestyle, and growing consumption of unhealthy diets among women, is expected to fuel the polycystic ovary syndrome market. LAS VEGAS, June 20, 2024 /PRNewswire/ -- DelveInsight's Polycystic Ovarian Syndrome Market Insights report includes a comprehensive understanding of current treatment practices, polycystic ovarian syndrome emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Polycystic Ovarian Syndrome Market Report According to DelveInsight's analysis, the market size for polycystic ovarian syndrome is expected to grow significantly by 2034. According to the data provided by the Centers for Disease Control and Prevention (CDC), PCOS is one of the most common causes of female infertility, affecting 6% to 12% of US women of reproductive age. According to the data published by NHS, PCOS is thought to be very common, affecting about 1 in every 10 women in the UK. Leading polycystic ovarian syndrome companies such as Spruce Biosciences, and others are developing novel polycystic ovarian syndrome drugs that can be available in the polycystic ovarian syndrome market in the coming years. The promising polycystic ovarian syndrome therapies in the pipeline include Tildacerfont, among others. Discover which therapies are expected to grab the major polycystic ovarian syndrome market share @ Polycystic Ovarian Syndrome Market Report Polycystic Ovarian Syndrome Overview Polycystic ovary syndrome (PCOS) is the most prevalent endocrine disorder in women, presenting a variety of signs, symptoms, and phenotypes. These can include reproductive, endocrine, and metabolic changes. PCOS is marked by dysfunction of the hypothalamic–pituitary–ovary axis and anovulation. Unlike other ovulatory failures characterized by inadequate ovarian follicle growth or suppressed gonadotropin secretion, PCOS usually involves androgen excess and subtle changes in serum levels of gonadotropins and estrogens that routine tests may not detect. The exact cause of PCOS remains unclear, but many women with the condition exhibit insulin resistance. Elevated insulin levels can lead to increased androgen production. Obesity can also raise insulin levels, exacerbating PCOS symptoms. PCOS often runs in families. Symptoms of PCOS may include missed or irregular periods, very light periods, enlarged ovaries or those with many cysts, excessive body hair (hirsutism) on the chest, stomach, and back, weight gain, particularly around the abdomen, acne or oily skin, and infertility. Polycystic Ovarian Syndrome Epidemiology Segmentation The polycystic ovarian syndrome epidemiology section provides insights into the historical and current polycystic ovarian syndrome patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The polycystic ovarian syndrome market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Polycystic Ovarian Syndrome Diagnosed Prevalent cases of Polycystic Ovarian Syndrome Treatable Cases of Polycystic Ovarian Syndrome Polycystic Ovarian Syndrome Treatment Market The primary goal of treating polycystic ovarian syndrome is to manage symptoms and lower the risk of long-term complications. Presently, most treatments target the patient's main concern. The focus of treatment is on alleviating symptoms of hyperandrogenism, regulating menstrual cycles, and facilitating conception. Maintaining a healthy weight by following a balanced diet and engaging in regular exercise can enhance insulin sensitivity and help regulate menstrual cycles in individuals with PCOS who are overweight or obese. Incorporating complex carbohydrates, lean proteins, and plenty of vegetables into the diet can be advantageous. Some women with PCOS might find a low-carbohydrate or low-glycemic index diet particularly beneficial. Physical activity also aids in improving insulin resistance and managing weight. Spironolactone and flutamide can help decrease excess hair growth and acne by inhibiting the effects of male hormones (androgens). While Metformin is not approved for PCOS treatment in the UK, it can be prescribed "off-label" due to its benefits for many women with PCOS who have insulin resistance. Metformin can aid in improving fertility, regulating menstrual cycles, and lowering miscarriage risks. Additionally, it offers long-term health benefits like reducing high cholesterol levels and decreasing the risk of heart disease. To know more about polycystic ovarian syndrome treatment guidelines, visit @ Polycystic Ovarian Syndrome Management Polycystic Ovarian Syndrome Pipeline Therapies and Key Companies The pipeline for PCOS is bleak with only a few companies working diligently. Of all the major market players, Spruce Biosciences is developing Tildacerfont. Tildacerfont is a CRF1 receptor antagonist developed to potentially provide significantly better disease management and reduce steroid use in patients with classic congenital adrenal hyperplasia and other conditions with elevated adrenocorticotropic hormone (ACTH) levels. It works by binding to CRF1 receptors in the pituitary gland, thereby inhibiting the overproduction of ACTH and reducing the production of adrenal androgens like androstenedione, a precursor to testosterone. Tildacerfont is typically well-tolerated in both healthy individuals and those with rare endocrine disorders. Spruce is carrying out the P.O.W.E.R. study, a randomized, placebo-controlled, dose-escalation trial to assess the safety and efficacy of tildacerfont titrated to 200 mg once daily compared to a placebo over 12 weeks in subjects with PCOS and elevated adrenal androgens, measured by baseline dehydroepiandrosterone sulfate (DHEAS) levels. PCOS is a common hormonal disorder in women of reproductive age, characterized by hirsutism, irregular menstrual cycles, infertility, and ovarian cysts. If approved, Tildacerfont could be beneficial for women with a rare form of PCOS resulting from hyperresponsiveness to adrenal androgens. Discover more about polycystic ovarian syndrome drugs in development @ Polycystic Ovarian Syndrome Clinical Trials Polycystic Ovarian Syndrome Market Dynamics The dynamics of the polycystic ovarian syndrome market are expected to change in the coming years. Rising awareness about PCOS and its associated complications, such as infertility, metabolic syndrome, and diabetes, has heightened the demand for effective diagnostic and treatment options. Advances in medical technology and diagnostics have also played a significant role, with improved imaging techniques and blood tests enabling earlier and more accurate detection of PCOS. Additionally, the growing emphasis on personalized medicine and tailored treatment regimens is fueling the market, as healthcare providers seek to offer more specific and effective therapies for managing PCOS symptoms. Furthermore, potential therapies are being investigated for the treatment of polycystic ovarian syndrome, and it is safe to predict that the treatment space will significantly impact the polycystic ovarian syndrome market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the polycystic ovarian syndrome market in the 7MM. However several factors may impede the growth of the polycystic ovarian syndrome market. One of the major challenges is the lack of standardized diagnostic criteria, which can lead to underdiagnosis or misdiagnosis, thus limiting the potential market size. Treatment adherence is another concern, as the chronic nature of PCOS often requires long-term management strategies that patients may find difficult to maintain. Furthermore, there is a need for more comprehensive and effective treatment options; current therapies primarily focus on symptom management rather than addressing the underlying causes of PCOS. Moreover, polycystic ovarian syndrome treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the polycystic ovarian syndrome market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the polycystic ovarian syndrome market growth. Scope of the Polycystic Ovarian Syndrome Market Report Therapeutic Assessment: Polycystic Ovarian Syndrome current marketed and emerging therapies Polycystic Ovarian Syndrome Market Dynamics: Key Market Forecast Assumptions of Emerging Polycystic Ovarian Syndrome Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Polycystic Ovarian Syndrome Market Access and Reimbursement Download the report to understand which factors are driving polycystic ovarian syndrome market trends @ Polycystic Ovarian Syndrome Market Trends Table of Contents Related Reports Polycystic Ovarian Syndrome Pipeline Polycystic Ovarian Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key polycystic ovarian syndrome companies, including Spruce Biosciences, Zydus Therapeutics, AbbVie, among others. Polycystic Ovarian Syndrome Epidemiology Forecast Polycystic Ovarian Syndrome Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted polycystic ovarian syndrome epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Type 2 Diabetes Pipeline Type 2 Diabetes Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key type 2 diabetes companies, including Sanofi, Eli Lilly and Company, Novartis, among others. Type 2 Diabetes Market Type 2 Diabetes Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key type 2 diabetes companies, including Eli Lilly and Company, Regor Pharmaceuticals Inc., AstraZeneca, Eccogene, Pfizer, Sciwind Biosciences USA Co., Ltd., MediciNova, Sparrow Pharmaceuticals, HighTide Biopharma Pty Ltd, Novo Nordisk A/S, Biomea Fusion Inc., Altimmune, Inc., Novartis, Amgen, Neuraly, Inc., Carmot Therapeutics, Inc., Inventiva Pharma, Inversago Pharma Inc, Applied Therapeutics, Inc. , among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

PORTLAND, Ore.--(BUSINESS WIRE)-- Sparrow Pharmaceuticals today presented data from an ongoing Phase 2 clinical trial of HSD-1 inhibitor clofutriben (SPI-62) and prednisolone in patients with polymyalgia rheumatica (PMR) at the 2024 Annual European Alliance for Associations for Rheumatology (EULAR 2024; June 12 – 15 in Vienna, Austria) that suggest HSD-1 inhibition can allow for effective treatment with glucocorticoid medicines with fewer side effects. A highlighted session, “75th Anniversary of Glucocorticoids – what have we learnt?” discussed recent clinical developments and key learnings from the use of glucocorticoids over the past 75 years. David Katz, PhD, Chief Scientific Officer at Sparrow, presented findings on the impact that co-administration of an HSD-1 inhibitor (clofutriben) with a glucocorticoid medicine (prednisolone) has on efficacy and glucocorticoid toxicity in patients with PMR. The findings highlight: Prednisolone 10mg combined with clofutriben 6mg demonstrated less efficacy compared to prednisolone 10mg administered with placebo, but with improvement on prednisolone toxicities (bone formation and resorption biomarkers, lipidemia, and insulin resistance.) Prednisolone 20mg combined with clofutriben 6mg demonstrated similar efficacy as determined by symptoms, physical function, and systemic inflammation, while maintaining improvement on markers of prednisolone toxicity, compared to prednisolone 10mg administered with placebo. “These new results suggest that glucocorticoids formed by HSD-1 have a large role in tissues where glucocorticoid excess causes morbidity, and a lesser role in the immune system where glucocorticoid medicines have efficacy,” said Dr. Katz. “We hope future clinical trials will demonstrate that prednisolone combined with clofutriben can be the effective and safe glucocorticoid medicine for which patients have waited over 75 years.” To learn more about Sparrow Pharmaceuticals and clofutriben (SPI-62), visit . About Sparrow Pharmaceuticals Sparrow Pharmaceuticals was founded to spare patients the ravages of steroids. Leveraging underappreciated scientific insights into glucocorticoid biology, the company is working to provide better treatment options for serious disorders of hypercortisolism, and to revolutionize the treatment of autoimmune and inflammatory conditions. Its lead product, clofutriben (SPI-62), is an oral, small molecule, novel therapeutic treatment designed to target a source of active intracellular glucocorticoids in key tissues. View source version on businesswire.com: Contacts Alexis Feinberg ICR Westwicke Alexis.Feinberg@westwicke.com 203-939-2225 Source: Sparrow Pharmaceuticals View this news release online at: