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Clinical Trial News

Wegovy Reduces Heart Attack and Stroke Risk in Heart Failure Patients

  • A new analysis of the Wegovy trial shows a 28% reduction in major adverse cardiac events, such as heart attack or stroke, in heart failure patients.
  • Patients taking Wegovy experienced a 24% reduction in heart disease-related deaths and a 19% reduction in deaths from any cause.
  • The benefits of Wegovy were observed regardless of the type of heart failure, including both preserved and reduced ejection fraction.
  • The study suggests semaglutide may improve blood sugar, blood pressure, and inflammation, potentially exerting direct benefits on the heart and blood vessels.

Study Finds No Increased Parkinson's Risk for Women with Migraines

  • A new study of over 39,000 women found no link between migraines and an increased risk of developing Parkinson's disease, refuting earlier research.
  • The 22-year follow-up showed that women with migraines were no more likely to develop Parkinson's than those without migraines, regardless of migraine frequency or aura.
  • Researchers emphasize that further studies are needed to confirm these findings across diverse populations, including men and various ethnic groups.
  • The results offer reassurance to women who experience migraines, alleviating concerns about a potential elevated risk of Parkinson's disease later in life.

mRNA Cancer Vaccine Clinical Trials Insight

The global mRNA cancer vaccines clinical trials and market future outlook for 2024 highlights over 60 vaccines in clinical trials, with the highest phase being Phase III. The US and China dominate the trials, with skin cancer vaccines leading. mRNA vaccines offer a personalized, targeted approach to cancer treatment, leveraging the body's immune system to combat cancer cells. They are being explored as combination therapies and for preventing cancer recurrence, with early results showing promise.

Lixte Biotechnology Faces Nasdaq Delisting Over Equity Shortfall, Plans Compliance Measures

  • Lixte Biotechnology received a Nasdaq notice for failing to meet the minimum stockholders' equity requirement of $2.5 million.
  • The company intends to submit a plan within 45 days to regain compliance and potentially receive a 180-day extension.
  • Lixte is conducting a clinical trial with the Netherlands Cancer Institute, testing LB-100 with Roche's atezolizumab for metastatic colon cancer.
  • Recent changes in director compensation policy shift from cash payments to equity-based remuneration to preserve cash.

FDA Accepts Bayer's Elinzanetant for Review in Menopausal Vasomotor Symptoms

  • The FDA has accepted Bayer's New Drug Application (NDA) for elinzanetant, a dual neurokinin-1,3 receptor antagonist, for treating moderate to severe vasomotor symptoms (VMS) associated with menopause.
  • The NDA is supported by positive data from the Phase III OASIS 1, 2, and 3 trials, demonstrating significant reductions in VMS frequency and severity compared to placebo.
  • Elinzanetant, administered orally once daily, modulates KNDy neurons in the hypothalamus, addressing the root cause of VMS due to estrogen decline.
  • If approved, elinzanetant will offer a novel non-hormonal option for women seeking relief from VMS, potentially improving sleep disturbances and quality of life.

A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause

NCT06112756CompletedPhase 2
Bayer
Posted 11/8/2023

A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2)

NCT05099159CompletedPhase 3
Bayer
Posted 10/29/2021

A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause

NCT05042362CompletedPhase 3
Bayer
Posted 8/27/2021

A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer

NCT05587296Active, Not RecruitingPhase 3
Bayer
Posted 10/14/2022

A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause

NCT05030584CompletedPhase 3
Bayer
Posted 8/27/2021

Pfizer and BioNTech's Omicron KP.2-Adapted COVID-19 Vaccine Receives Positive CHMP Opinion

  • The EMA's CHMP recommended marketing authorization for Pfizer and BioNTech's Omicron KP.2-adapted COVID-19 vaccine for individuals aged 6 months and older.
  • The recommendation is based on data showing an improved response against multiple Omicron JN.1 sublineages compared to the XBB.1.5-adapted vaccine.
  • Following European Commission authorization, the vaccine will be shipped to EU member states that have specifically ordered this formulation.
  • The FDA approved the Omicron KP.2-adapted vaccine in the U.S. on August 22, 2024, for individuals 12 years and older, with emergency use authorization for ages 6 months to 11 years.

Bayer's Phase II Trial of BAY3283142 Aims to Treat Chronic Kidney Disease

  • Bayer has initiated the ALPINE-1 Phase II clinical trial to evaluate BAY3283142, a soluble guanylate cyclase (sGC) activator, for treating chronic kidney disease (CKD).
  • The ALPINE-1 study is a randomized, double-blind, placebo-controlled, multi-center trial assessing the efficacy and safety of BAY3283142 in CKD patients.
  • BAY3283142 modulates the nitric oxide (NO)-soluble guanylate cyclase (sGC)-cyclic guanosine monophosphate (cGMP) pathway, showing potential in cardiovascular diseases.
  • CKD affects over 10% of the global population and is a significant risk factor for cardiovascular disease, highlighting the need for effective treatments.

NICE Rejects Alzheimer's Drug Lecanemab Despite MHRA Approval, Creating Two-Tier Access System

  • The UK's medicines regulator (MHRA) has approved lecanemab for Alzheimer's disease, but NICE has deemed it not cost-effective for NHS use in England and Wales, limiting access to private patients willing to pay approximately £20,000 annually.
  • Lecanemab, sold as Leqembi, works with the immune system to reduce amyloid protein buildup and has shown to slow cognitive decline by 27% and quality of life decline by up to 56% in early-stage Alzheimer's patients during clinical trials.
  • Alzheimer Scotland has criticized NICE's decision as "short-sighted" and urged the Scottish Medicines Consortium to approve the drug, arguing it represents a crucial first step in disease-modifying treatment despite being suitable only for patients in early disease stages.

Key Leadership Changes Reshape Pharmaceutical Services Landscape in July 2024

  • Selkirk Pharma appoints former AstraZeneca executive Colleen Dixon as CEO, bringing extensive leadership experience from major pharmaceutical companies to strengthen their injectable drugs manufacturing operations.
  • Multiple CDMOs and clinical trial technology companies enhance their executive teams, with Oxford Biomedica and Veranova adding new C-suite leaders to drive strategic growth.
  • Several CROs including MMS, Metrion Biosciences, and Catawba Research bolster their commercial leadership, reflecting industry-wide focus on business development and market expansion.

Sanofi's KT-474 Shows Promise as First-in-Class MyD88 Inhibitor for Inflammatory Diseases

  • KT-474, a novel small molecule, selectively inhibits MyD88, a key signaling protein in inflammatory pathways, offering a potential new approach to treating immune-mediated diseases.
  • Preclinical data suggest KT-474's unique mechanism of action could provide therapeutic benefits in conditions where MyD88 signaling is dysregulated.
  • Sanofi is advancing KT-474, also known as SAR444656, as a potential first-in-class therapy, highlighting its innovative approach to targeting the MyD88 pathway.
  • The development of KT-474 represents a significant advancement in the pursuit of selective inhibitors for challenging targets within the innate immune system.
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