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Clinical Trial News

Ensitrelvir Shows Promise in Reducing COVID-19 Symptom Development in Exploratory Trial

  • An exploratory phase 2b/3 trial suggests that ensitrelvir may reduce the risk of developing COVID-19 symptoms in asymptomatic or mildly symptomatic individuals.
  • The study found a 77% reduction in the risk of developing any of 14 COVID-19 symptoms or fever with the 125-mg dose of ensitrelvir compared to placebo.
  • Ensitrelvir demonstrated statistically significant antiviral efficacy, reducing viral RNA, viral titer, and time to infectious viral clearance versus placebo.
  • The treatment was generally well-tolerated, with most treatment-related adverse events being mild to moderate in severity.

LSU Health Shreveport to Explore Psilocybin for Methamphetamine Addiction Treatment in Clinical Trial

  • LSU Health Shreveport is launching a clinical trial to investigate psilocybin as a potential treatment for methamphetamine addiction.
  • The trial will be led by Dr. Shawn McNeil, Kevin Murnane, PhD, and PhD candidate Frances Vest at the Louisiana Addiction Research Center.
  • The study aims to address the prevalence of methamphetamine addiction and explore new therapeutic avenues using psilocybin.
  • Researchers will assess the efficacy of psilocybin in reducing addiction-related behaviors and improving mental health outcomes.

Real-World Data Emulation Study Challenges Clinical Trial Findings on Apixaban and Warfarin

  • Researchers emulated a clinical trial using real-world data to compare apixaban and warfarin for stroke prevention in atrial fibrillation patients.
  • The emulation study found similar outcomes for both drugs, differing from the original trial that favored apixaban.
  • Discrepancies may stem from better warfarin control, suboptimal apixaban dosing, and differences in patient ethnicity and concomitant medication use.
  • The approach could help assess treatment effects in underrepresented groups and validate trial results in real-world settings.

FDA Issues New Guidance to Enhance Diversity and Efficiency in Clinical Trials

  • The FDA has finalized guidance on decentralized clinical trials (DCTs), enabling study activities at patients' homes and local healthcare facilities.
  • New FDA guidance emphasizes the need for diverse patient populations in clinical trials, requiring sponsors to submit Diversity Action Plans (DAPs).
  • The FDA encourages oncology sponsors to conduct multiregional clinical trials (MRCTs) while ensuring results are applicable to U.S. populations and healthcare practices.
  • The FDA promotes integrating real-world evidence (RWE) and data from diverse sources, such as electronic health records (EHRs), to support clinical development.

Phase 2 Trial Assesses Felodipine Tolerability for Huntington's Disease

  • A Phase 2 clinical trial (FELL-HD) is underway to evaluate the tolerability of felodipine in patients with early-stage Huntington's Disease (HD).
  • The open-label, dose-finding study will enroll 18 participants aged 35-70 with genetically confirmed HD to test three different doses of felodipine over 58 weeks.
  • The primary outcome is the number of adverse events, with secondary outcomes including quality of life, cognitive and motor function, and biomarker changes.
  • Felodipine, an approved hypertension drug, has shown autophagy-inducing effects in preclinical HD models, potentially aiding in the degradation of toxic mutant huntingtin protein.

Keytruda Fails in Phase 3 Trials for Early-Stage Lung and Skin Cancer

  • Merck's Keytruda, when added to standard treatments, failed to improve survival in patients with early-stage non-small cell lung cancer in the KEYNOTE-867 trial.
  • Similarly, Keytruda did not demonstrate a statistically significant improvement in recurrence-free survival for cutaneous squamous cell carcinoma patients after surgery and radiation in the KEYNOTE-630 trial.
  • Due to the lack of efficacy and increased side effects, including fatal adverse events in the lung cancer trial, both studies were halted early based on independent data analysis recommendations.
  • These setbacks challenge Merck's strategy to broaden Keytruda's applications before its patent expiration, despite significant investment in its development.

Merck Discontinues Phase 3 Trials of Pembrolizumab in NSCLC and CSCC

  • Merck has halted the KEYNOTE-867 trial of pembrolizumab plus stereotactic body radiotherapy (SBRT) for stage I/II NSCLC due to lack of efficacy in improving event-free or overall survival.
  • The KEYNOTE-630 trial, evaluating pembrolizumab for adjuvant treatment of high-risk, locally advanced CSCC, was also discontinued due to futility based on preplanned analysis.
  • Data analysis from both trials is ongoing, and Merck plans to share the findings with the scientific community and regulatory agencies, with investigators informing trial participants.

Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)

NCT03924869TerminatedPhase 3
Merck Sharp & Dohme LLC
Posted 6/25/2019

Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)

NCT03833167Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 4/1/2019

Ireland Standardizes Clinical Trial Agreements to Boost Trial Performance

  • Ireland is introducing a standardized four-way model template for clinical trial agreements (CTAs) to enhance its clinical trial performance.
  • The new template involves commercial sponsors, contract research organizations (CROs), academic partners, and hospitals, aiming to reduce costs and delays.
  • Standardized CTAs are expected to streamline the setup of new trials, addressing Ireland's underperformance compared to other European countries.
  • The initiative follows the implementation of bipartite and tripartite CTAs and is a collaborative effort with the Irish Pharmaceutical Healthcare Association (IPHA).

NIH Grant Funds Novel Trial Combining CGM, Activity Trackers, and Smartphone App for Youth-Onset Type 2 Diabetes

  • A new NIH-funded clinical trial, REFLECT2D, will address the increasing challenge of treating type 2 diabetes (T2D) in adolescents and young adults (AYA).
  • The trial combines continuous glucose monitoring (CGM) with a mobile app and activity tracker to allow real-time monitoring and personalized health prompts.
  • The study will enroll 100 participants aged 16-24 with T2D, utilizing the Healthmine app with tailored interventions to improve blood sugar control.
  • The research aims to assess the impacts of app-based prompts on blood sugar levels and health behaviors, ultimately reducing health disparities and improving outcomes.

UK Boy Enrolls in Global Trial for Novel Low-Grade Glioma Drug

  • A six-year-old boy from Peterborough is the first UK participant in a global clinical trial for a novel drug targeting low-grade gliomas.
  • The trial evaluates the efficacy of a new drug against standard chemotherapy in newly diagnosed pediatric low-grade gliomas with RAF alterations.
  • The investigational drug, developed by a US biotech, aims to stabilize tumors, induce shrinkage, and reduce long-term side effects compared to traditional treatments.
  • The trial includes a crossover option, allowing patients initially assigned to chemotherapy to receive the investigational drug if the initial treatment proves ineffective.

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