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Clinical Trial News

Galderma Reports Nine-Month Efficacy Data for Combined Sculptra and Restylane Treatment in GLP-1-Associated Facial Volume Loss

  • Galderma's phase IV clinical trial demonstrates sustained efficacy of combined Sculptra and Restylane Lyft or Contour treatment for facial volume loss associated with GLP-1 receptor agonist medications over nine months.
  • The study showed high patient satisfaction rates, with 88.6% of patients reporting they "loved" how the treatment maintained their facial structure and 91.4% would recommend the regimen to others.
  • Results indicate the combination therapy improved skin quality, with Restylane enhancing hydration and Sculptra significantly improving skin radiance through month nine.
  • The treatment regimen demonstrated a favorable safety profile with no treatment-related adverse events reported, consistent with previous pivotal trial data.

COVID-19 Boosters Reduce Hospitalization Risk by 29% in Cancer Patients, Large Multi-Center Study Shows

Real World Evidence
  • A large retrospective study of over 161,000 cancer patients across four major U.S. health systems found that COVID-19 booster vaccines reduced hospitalizations and ICU admissions by 29%.
  • The study showed that boosters prevented one hospitalization or ICU admission for every 150-166 boosted cancer patients, demonstrating significant clinical benefit for this vulnerable population.
  • Despite the proven effectiveness, booster uptake among cancer patients remained low, with only 68% receiving the original booster and 38% receiving the updated bivalent booster.
  • The research provides real-world evidence supporting vaccination recommendations for cancer patients, whose immune systems are often compromised by their disease and treatments.

British Columbia Restricts Sales of Diabetes Drugs Tirzepatide and Dulaglutide to Combat Weight Loss-Driven Shortages

  • British Columbia's Health Ministry has implemented sales restrictions on tirzepatide (Mounjaro) and dulaglutide (Trulicity) to preserve supply for diabetic patients amid widespread off-label weight loss use.
  • The new regulations follow similar 2023 restrictions on semaglutide (Ozempic) and prohibit pharmacists from selling these drugs to non-Canadian residents or those not physically present at the pharmacy.
  • Health Minister Josie Osborne cited international shortages driven by weight loss demand, particularly in the United States, as the primary reason for implementing these protective measures.
  • The College of Pharmacists of B.C. will oversee compliance with the new regulations while allowing foreign citizens with valid Canadian prescriptions to purchase medications in person.

Eledon Pharmaceuticals to Present Updated Phase 1b Kidney Transplant Data for Tegoprubart at World Transplant Congress 2025

Monoclonal Antibody
  • Eledon Pharmaceuticals will present updated clinical data from approximately 30 kidney transplant recipients in their ongoing Phase 1b study of tegoprubart at the World Transplant Congress in San Francisco.
  • The anti-CD40L antibody tegoprubart is being developed for kidney transplant rejection prevention and will be featured in an oral presentation by Dr. John Gill from the University of British Columbia.
  • Additional preclinical data will showcase tegoprubart's potential in liver transplantation using non-human primate models, indicating expanded therapeutic applications beyond kidney transplantation.
  • The company will sponsor a satellite symposium exploring long-term transplant success metrics, positioning tegoprubart in the context of lasting graft function rather than just short-term rejection prevention.

Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

NCT05983770Active, Not RecruitingPhase 2
Eledon Pharmaceuticals
Posted 8/30/2023

Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients

NCT06126380Unknown StatusPhase 2
Eledon Pharmaceuticals
Posted 10/25/2023

Neurogen Biomarking to Present Validation Data for At-Home Alzheimer's Blood Biomarker Test at AAIC 2025

  • Neurogen Biomarking will present novel validation data on at-home p-tau 217 blood testing for Alzheimer's disease at the Alzheimer's Association International Conference in Toronto.
  • The company's Chief Scientific Officer Elisabeth Thijssen will report results from a study designed to validate remote collection of blood biomarkers for Alzheimer's disease and related disorders.
  • AAIC has designated Neurogen's presentation as a Clinical Pearl for its real-world relevance to dementia diagnosis and care, highlighting the potential impact of accessible biomarker testing.
  • Neurogen offers the first at-home blood biomarker test for phosphorylated tau-217 using proprietary collection technology combined with digital cognitive testing and telehealth neurologist guidance.

A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease

NCT04619420Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 1/6/2021

Canadian Real-World Study Shows Comparable Remission Rates Between Etanercept Biosimilars and Originator in Rheumatoid Arthritis

Real World Evidence
  • A Canadian real-world evidence study of 150 rheumatoid arthritis patients found no significant differences in remission outcomes between etanercept biosimilars (Brenzys and Erelzi) and the originator drug Enbrel.
  • Patients receiving biosimilars achieved first remission in a median of 8.7 months compared to 14.5 months for originator users, though this difference was not statistically significant.
  • The study reinforces findings from randomized controlled trials and European registry data, supporting the clinical interchangeability of etanercept biosimilars with the reference product.
  • These results contribute to growing evidence that biosimilars can expand treatment access while reducing healthcare costs, particularly important as biologics accounted for 27.3% of Canadian public drug expenditures in 2018.

NIHR Pilots 'Just in Time' Clinical Trial Initiative for Pancreatic Cancer Using Pembrolizumab-Olaparib Combination

Precision MedicineOncology
  • The National Institute for Health and Care Research is piloting a 'Just in Time' scheme that could reduce clinical trial setup time from months to days, potentially improving patient access to trials closer to home.
  • The initiative is being tested in the PemOla trial, which explores combination immunotherapy using pembrolizumab and olaparib for pancreatic cancers with high genetic mutation burden.
  • Pancreatic cancer remains one of the most challenging cancers to treat, with only 5% of patients surviving more than 10 years and limited progress in outcomes over the past 50 years.
  • The scheme enables hospitals to join trials when eligible patients are identified, potentially accelerating recruitment and speeding development of precision medicines for rare patient groups.

FDA Expert Panel Calls for Revision of Menopausal Hormone Therapy Warning Labels

  • An FDA expert panel convened to reassess boxed warnings for menopausal hormone therapy, with multiple experts arguing that current labels overstate risks and are not supported by comprehensive scientific evidence.
  • Panel members presented data showing that vaginal estrogen products carry significantly different safety profiles than systemic hormone therapy, yet both carry identical boxed warnings due to class labeling regulations.
  • Experts highlighted critical gaps in medical education, noting that only 31.3% of U.S. residency programs have standardized menopause training, contributing to underutilization of beneficial therapies.
  • The panel emphasized that reanalysis of Women's Health Initiative data shows favorable outcomes for women aged 50-59 years, with estrogen alone linked to reduced breast cancer incidence and mortality over long-term follow-up.

Acute Ischemic Stroke Pipeline Shows Promise with 25+ Therapies in Development and Recent Clinical Breakthroughs

FDA ApprovalMonoclonal Antibody
  • DelveInsight's 2025 analysis reveals over 20 key companies are developing 25+ acute ischemic stroke therapies across various clinical phases, representing significant advancement in stroke treatment research.
  • Recent clinical trials demonstrate promising results, including the ASSET-IT trial showing 65.9% excellent recovery rates with tirofiban combination therapy compared to 54.9% with placebo.
  • Multiple FDA designations have been granted, including Fast Track status for PP-007 and Orphan Drug Designation for CIRARA, accelerating development timelines for innovative stroke treatments.
  • The pipeline encompasses diverse therapeutic approaches including monoclonal antibodies, small molecules, and cell therapies, targeting various mechanisms from neuroprotection to thrombolysis enhancement.

Efficacy of Sovateltide (PMZ-1620) in Patients of Acute Ischemic Stroke

NCT04047563CompletedPhase 3
Pharmazz, Inc.
Posted 11/10/2019

PMZ-1620 (Sovateltide) in Acute Ischemic Stroke Patients

NCT04046484CompletedPhase 2
Pharmazz, Inc.
Posted 1/19/2018

Multi-Cancer Detection Blood Tests Enter Major Clinical Trial Across Virginia and Missouri

  • Researchers are launching the Vanguard Study to evaluate Multi-Cancer Detection (MCD) tests that can screen for up to ten different cancer types using a single blood draw.
  • The study aims to recruit 2,000 participants aged 45-75 across Virginia and Missouri, with a focus on detecting cancers that currently lack recommended screening methods.
  • MCD tests identify biological substances released by cancer cells in the bloodstream and could complement existing screening programs for breast, colorectal, lung, and prostate cancers.
  • The three-year randomized trial will provide free testing to participants, addressing a significant gap as current MCD tests cost up to $1,000 and are not covered by insurance.

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