Elismetrep

Kallyope has removed one of its weight loss candidates from its online pipeline and shuffled metabolic diseases lower on its priority list, below its efforts on neurological disorders.The changes on the company's website were spotted this week after the results of a Phase II obesity study were quietly posted to ClinicalTrials.gov — the same day a Phase IIb trial testing Kallyope's elismetrep (K-304) in patients with migraine was listed on the site.The obesity study's outcome could, in part, explain the lack of fanfare. While the combination of Kallyope's two oral "nutrient receptor agonists" K-757 and K-833 may have demonstrated a more tolerable gastrointestinal (GI) profile than other oral contenders, the rate of weight loss seen in the study falls well short of the levels achieved by the pack leaders (see – Vital Signs: A safety snapshot of oral GLP-1s).Kallyope had raised a $236-million series D in 2022 on the strength of its metabolic and GI programmes.Less than 3% weight lossKallyope was evaluating K-757 alone, and in combination with K-833, against placebo in 155 participants with obesity and without diabetes. The company has previously described the two compounds as agonists that "stimulate the secretion of multiple appetite-suppressing satiety hormones, including GLP-1, and several other well validated satiety hormones, such as PYY and CCK" (see – Vital Signs: Mapping the next generation of obesity targets after GLP).After 13 weeks, K-757 led to a 1.57% reduction in weight from baseline, while patients who received the duo saw a 2.94% decline; those in the placebo arm had a 0.15% reduction.Of the 52 patients who received K-757 plus K-833, 14 discontinued treatment due to an adverse event (AE). The overall AE rate in the cohort was 80.8%, with the most common side effects being nausea (51.9%), constipation (36.5%), vomiting (23.1%), dyspepsia (19.2%) and diarrhoea (11.5%).K-833 is no longer listed on Kallyope's pipeline, leaving K-757 as the sole disclosed metabolic candidate. The company lists three undisclosed assets in the discovery stage for the disease area, while three neurology programmes are named on its website. Outshined by competitors Keeping in mind the caveats with cross-trial comparisons, the rate of weight loss seen with Kallyope's combo appears to be less than a quarter than that of Novo Nordisk's oral obesity hopeful in a similar timeframe. At the European Association for the Study of Diabetes (EASD) meeting last year, the Danish drugmaker reported that patients given oral amycretin achieved mean weight loss of 13.1% after 12 weeks.Two other oral candidates have achieved a greater degree of weight loss in less time — albeit in far fewer participants. Roche's CT-996 showed placebo-adjusted mean weight loss of 6.1% in six patients at week four in a Phase I study; and earlier this month, China-based Ascletis reported up to a 6.2% weight reduction at week four in eight patients given its homegrown oral GLP-1 agonist ASC30. Phase III data for Eli Lilly's oral GLP-1, orforglipron, are due next quarter — and it's one of the most highly anticipated readouts of the year. At the American Diabetes Association (ADA) scientific sessions in 2023, the pharma reported weight loss of up to 12.6% after 26 weeks (see – Spotlight On: Viking, Structure prep for Eli Lilly's oral GLP-1 reckoning).

The menopause market is anticipated to surge significantly in the coming years due to the emergence of new products in the pipeline. In addition, persistently rising cases of menopause in the forecast period will help increase the menopause treatment market. LAS VEGAS, Sept. 12, 2023 /PRNewswire/ -- DelveInsight's Menopause Market Insights report includes a comprehensive understanding of current treatment practices, menopause emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Key Takeaways from the Menopause Market Report As per DelveInsight analysis, the menopause market size in the 7MM was approximately USD 11 billion in 2022. According to the assessment done by DelveInsight, the total number of women in menopause in the 7MM comprised approximately 100 million cases in 2022 and are projected to increase during the forecast period. Leading menopause companies such as Viramal Limited, Simbec Research, Estetra, Mithra Pharmaceuticals, Bayer, Nerre Therapeutics Ltd., Mitsubishi Tanabe Pharma America Inc., MenoGeniX, QUE Oncology, Fervent Pharmaceuticals, and others are developing novel menopause drugs that can be available in the menopause market in the coming years. The promising menopause therapies in the pipeline include Transdermal Estradiol Cream (VML-0203), DONESTA (E4, Estetrol), Elinzanetant (BAY3427080), MT-8554 (Elismetrep), MNGX-100 (Filgrastim/G-CSF), Q-122 (MSX-122), FP-101, and others. Discover which therapies are expected to grab the major menopause market share @ Menopause Market Report Menopause Overview Menopause is a natural biological process that marks the end of a woman's reproductive years. It usually occurs between the ages of 45 and 55, with an average age of around 51. This phase is characterized by a decline in the production of hormones like estrogen and progesterone, leading to the cessation of menstruation and fertility. The primary cause of menopause is the aging of the ovaries, which results in a reduced number of eggs and a decline in hormone production. However, certain medical procedures like hysterectomy, chemotherapy, and radiation therapy can induce menopause prematurely. Menopause brings about a range of symptoms that can vary widely from woman to woman. Common menopause symptoms include hot flashes, night sweats, mood swings, irritability, fatigue, vaginal dryness, and sleep disturbances. These symptoms occur due to the hormonal fluctuations that take place during the transition to menopause. Diagnosing menopause is often based on a woman's age, medical history, and symptoms. A key factor is the absence of menstruation for 12 consecutive months, signaling the end of the reproductive period. In some cases, healthcare providers may recommend blood tests to measure hormone levels, such as follicle-stimulating hormone (FSH) and estrogen, to confirm the onset of menopause. Menopause Epidemiology Segmentation DelveInsight estimates that there were approximately 100 million total women in menopause in the 7MM in 2022. For the age-specific analysis, the number of cases of menopause were distributed across various age groups, such as <40 years, 40–50 years, 51–60 years, and 61–65 years, in the 7MM. As per the analysis, the highest number of cases were estimated in the age-group 51-60 years and the lowest in <40 years with 64 million and 3.4 million cases, respectively in 2022. The menopause market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Number of Women in Menopause Stage-Specific Distribution of Women in Menopause Age-Specific Distribution of Women in Menopause Number of Women in Menopause with Vasomotor Symptoms Number of Women in Menopause with Moderate-to-Severe Vasomotor Symptoms Menopause Treatment Market The North American Menopause Society (NAMS) suggests waiting until the hot flashes become troublesome to the woman before seeking treatment. The intensity of symptoms, an assessment of treatment-related risks, and the woman's views towards menopause and drugs should all be considered before starting treatment. Duavee (bazedoxifene acetate/conjugated estrogens) is the first and only medicine that combines CE with an estrogen agonist/antagonist, commonly known as a selective estrogen receptor modulator (SERM), for the treatment of menopausal VMS. Duavee employs bazedoxifene rather than progestin to help protect the uterine lining from hyperplasia that may occur as a result of estrogen-only treatment. Many women use non-prescription therapies to address disorders such as hot flashes, such as isoflavones, black cohosh, and progesterone-containing hormone lotions. The clinical evidence for the efficacy and long-term safety of these therapies is insufficient. Furthermore, most over-the-counter medications for hot flashes are classified as nutritional supplements and, as such, are not regulated by the US Food and Drug Administration. Prescription medications for various purposes that have demonstrated some benefit in alleviating hot flashes are available for women who have hot flashes but cannot undergo hormone therapy. Certain prescription antidepressants may reduce hot flashes in women, including those with a history of breast cancer. Others include gabapentin, clonidine, and methyldopa. The NAMS recommends that women who need relief from mild menopause-related hot flashes first consider lifestyle changes such as manipulating the environment to keep the core body temperature cool, getting regular exercise, quitting smoking, and using relaxation techniques such as paced respiration. To know more about menopause treatment, visit @ Menopause Treatment Drugs Key Menopause Therapies and Companies Transdermal Estradiol Cream (VML-0203): Viramal Limited/Simbec Research DONESTA (E4, Estetrol): Estetra/Mithra Pharmaceuticals Elinzanetant (BAY3427080): Bayer|Nerre Therapeutics Ltd. MT-8554 (Elismetrep): Mitsubishi Tanabe Pharma America Inc. MNGX-100 (Filgrastim/G-CSF): MenoGeniX Q-122 (MSX-122): QUE Oncology FP-101: Fervent Pharmaceuticals Learn more about the FDA-approved drugs for menopause @ Drugs for Menopause Treatment Menopause Market Dynamics The menopause market dynamics are undergoing significant shifts as societal awareness of women's health and well-being continues to grow. With an aging population and increasing focus on women's empowerment, there's a heightened demand for innovative products and services addressing the physical and emotional challenges associated with menopause. This has spurred a surge in research and development, leading to the creation of a diverse range of hormone replacement therapies, herbal supplements, lifestyle apps, and personalized health plans. As more women seek effective and holistic solutions, companies are embracing a more consumer-centric approach, tailoring their offerings to individual needs and preferences. Additionally, discussions around menopause are becoming less taboo, allowing for open dialogue and information-sharing, further shaping the menopause market dynamics by fostering a supportive ecosystem for women navigating this life stage. However, despite the potential for growth, this menopause market is not without its barriers. Stringent regulatory processes for hormonal treatments and supplements, coupled with concerns about product safety and efficacy, pose challenges for menopause market entrants. Additionally, cultural stigmas and misinformation surrounding menopause still exist in certain societies, inhibiting open discussions and the adoption of new solutions. Economic disparities and limited access to healthcare further compound these issues, preventing equal menopause market penetration. Overcoming these barriers requires a multi-faceted approach, involving education, regulatory reforms, and inclusive product development, to truly tap into the menopause market's potential. Scope of the Menopause Market Report Therapeutic Assessment: Menopause current marketed and emerging therapies Menopause Market Dynamics: Attribute Analysis of Emerging Menopause Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's Views, Analyst's Views, Menopause Market Access and Reimbursement Discover more about menopause drugs in development @ Menopause Clinical Trials Table of Contents Related Reports Hot Flashes Pipeline Hot Flashes Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key hot flashes companies, including Veru Healthcare, Fervent Pharmaceuticals, Ogeda, Bayer, Lundbeck A/S, TherapeuticsMD, MenoGeniX, Mitsubishi Tanabe Pharma, QUE Oncology, Pherin Pharmaceuticals, among others. Hot Flashes Market Hot Flashes Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key hot flashes companies, including Veru Healthcare, Fervent Pharmaceuticals, Ogeda, Bayer, Lundbeck A/S, TherapeuticsMD, MenoGeniX, Mitsubishi Tanabe Pharma, QUE Oncology, among others. Menopause Global Market Menopause Market Insights, Competitive Landscape, and Market Forecast – 2028 report deliver an in-depth understanding of the disease, market trends, market drivers, market barriers, and key menopause companies including ISIDEN, Novapharm, Arkopharma, Pileje, Thermamex, ÉLERTÉ Laboratories, Serelys Pharma, Besins Healthcare, Bayer, ITALFARMACO S.p.A, Pfizer Inc, Mylan NV, Teva Pharmaceuticals, TherapeuticsMD, Inc, Novo Nordisk, Novartis, Millicent Pharma, PADAGIS LLC, Vertical Pharmaceuticals LLC, Amgen, among others. Vasomotor Symptoms of Menopause Pipeline Vasomotor Symptoms of Menopause Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key vasomotor symptoms of menopause companies, including Mithra Pharmaceuticals, Acer Therapeutics, QUE Oncology, Bayer, Endoceutics, Astellas Pharma, Mitsubishi Tanabe Pharma, MenoGenix, 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] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP