MedPath

Clinical Trial News

FDA Approves Merck's ENFLONSIA for RSV Prevention in Infants with Single Weight-Independent Dose

Drug ApprovalMonoclonal Antibody
  • The U.S. FDA has approved Merck's ENFLONSIA (clesrovimab-cfor), a long-acting monoclonal antibody for preventing RSV lower respiratory tract disease in newborns and infants entering their first RSV season.
  • ENFLONSIA demonstrated a 60.5% reduction in RSV-associated medically attended lower respiratory infections and an 84.3% reduction in RSV-related hospitalizations compared to placebo in the pivotal CLEVER trial.
  • The therapy offers the first weight-independent dosing approach for RSV prevention, using a single 105 mg dose regardless of infant weight to provide protection through a typical 5-month RSV season.
  • Ordering is expected to begin in July 2025, with shipments delivered before the 2025-2026 RSV season, pending CDC Advisory Committee recommendations later this month.

Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

NCT04938830CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 11/30/2021

Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)

NCT04767373CompletedPhase 2
Merck Sharp & Dohme LLC
Posted 4/7/2021

Real-World Evidence Validates Clinical Trial Outcomes in Advanced Urothelial Carcinoma Treatment

Real World Evidence
  • Real-world studies demonstrate that enfortumab vedotin plus pembrolizumab and avelumab maintenance therapy achieve outcomes similar to clinical trials in urothelial carcinoma patients.
  • The UNITE study revealed biomarker insights showing patients with TP53 or KMT2D mutations had worse outcomes with enfortumab vedotin-pembrolizumab combination therapy.
  • Real-world data help bridge gaps in clinical trial populations by including older patients and those with comorbidities typically excluded from trials.
  • Treatment selection increasingly relies on patient characteristics including metastatic sites, with lymph node-only disease showing particularly favorable outcomes across multiple regimens.

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

NCT04223856Active, Not RecruitingPhase 3
Astellas Pharma Global Development, Inc.
Posted 3/30/2020

A NON-INTERVENTIONAL STUDY ON AVELUMAB USE IN PATIENTS WITH ADVANCED OR METASTATIC UROTHELIAL CARCINOMA

NCT04822350Completed
Pfizer
Posted 7/13/2021

A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)

NCT02603432CompletedPhase 3
Pfizer
Posted 4/25/2016

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer

NCT03036098Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 3/24/2017

Psilera Partners with Hesperos to Advance Organ-on-a-Chip Testing for Frontotemporal Dementia Drug

  • Psilera and Hesperos have formed a strategic partnership to accelerate preclinical development of PSIL-006, a next-generation neuroplastogen targeting frontotemporal dementia using advanced organ-on-a-chip technology.
  • Hesperos' Human-on-a-Chip® platform integrates patient-derived stem cells into multi-organ systems to replicate human physiological responses and has successfully supported multiple FDA IND and Orphan Drug Designation applications.
  • The collaboration aligns with recent FDA policy shifts promoting human-based lab models as alternatives to animal testing, potentially enabling faster and more precise drug development.
  • Results from the preclinical modeling are expected in Q3 2025, as Psilera prepares for first-in-human trials of their frontotemporal dementia treatment.

Concentra Biosciences to Acquire Elevation Oncology for $0.36 Per Share Plus Contingent Value Rights

Oncology
  • Concentra Biosciences has entered into a definitive merger agreement to acquire Elevation Oncology for $0.36 in cash per share plus contingent value rights.
  • The contingent value rights include 100% of closing net cash exceeding $26.4 million and 80% of net proceeds from EO-1022 disposition within specified timeframes.
  • Elevation Oncology's Board of Directors unanimously approved the acquisition, with the tender offer expected to commence by June 23, 2025 and transaction closure anticipated in July 2025.
  • Company officers, directors and affiliates holding approximately 5.1% of common stock have signed agreements to tender their shares and support the merger transaction.

Scottish Health Authority Rejects Alzheimer's Drug Donanemab Despite UK Regulatory Approval

Monoclonal Antibody
  • The Scottish Medicines Consortium rejected donanemab (Kisunla) for NHS Scotland use, citing uncertainty around the drug's modest clinical benefit despite UK regulatory approval in October.
  • This marks the second Alzheimer's drug rejection by Scottish authorities in three months, following a similar decision on lecanemab (Leqembi).
  • Alzheimer Scotland advocates are calling for a specialized Dementia Drugs Fund and reformed assessment processes, arguing current evaluation methods are inadequate for addressing the UK's leading cause of death.
  • Donanemab works by targeting amyloid protein buildup in the brain through antibody infusions, potentially slowing Alzheimer's progression by up to two years in some cases.

Aethlon Medical's Hemopurifier Shows Promise for Long COVID Treatment Through Extracellular Vesicle Removal

  • Aethlon Medical will present pre-clinical data at the Keystone Symposium showing their Hemopurifier device can bind extracellular vesicles from Long COVID patients.
  • The study, conducted with UC San Francisco, found that extracellular vesicles from Long COVID participants contain mannose targets that bind to the device's proprietary affinity resin.
  • Long COVID affects 44-48 million Americans with a $2 billion economic burden, yet no effective treatments exist despite over $1 billion in research funding.
  • The Hemopurifier is an FDA Breakthrough Device that uses lectin-based technology to remove harmful extracellular vesicles implicated in Long COVID pathogenesis.

Electric Fields Combined with Immunotherapy Show 70% Survival Improvement in Glioblastoma Patients

  • A Phase 2 trial demonstrated that combining Tumor Treating Fields (TTFields) with immunotherapy and chemotherapy increased overall survival by 70% in newly diagnosed glioblastoma patients.
  • TTFields enhanced immune response by attracting more T cells into tumors and improving the effectiveness of pembrolizumab immunotherapy through in situ immunization.
  • Patients with large, inoperable tumors showed particularly strong responses, living approximately 13 months longer with enhanced immune activation compared to those who underwent surgical tumor removal.
  • A Phase 3 trial is now underway across 28 sites to validate these findings in over 740 participants through April 2029.

Mosanna Therapeutics Secures $80M Series A to Advance Nasal Spray Treatment for Obstructive Sleep Apnea

  • Mosanna Therapeutics raised $80 million in Series A funding led by EQT Life Sciences and Pivotal bioVenture Partners to advance its nasal spray therapy MOS118 through Phase 2 clinical trials.
  • The company's lead therapy MOS118 represents a pharmaceutical approach to treating obstructive sleep apnea by targeting upper airway muscles and restoring the body's natural airway reflex.
  • Obstructive sleep apnea affects nearly 1 billion people globally, with the majority undiagnosed and underserved by current mechanical treatment options.
  • Biotech veteran David Weber has been appointed CEO to lead the company through clinical development of this novel neurological and muscular dysfunction approach.

RxMP Therapeutics Advances Hemostatic Agent RMP-402 with DoD Partnership and FDA Manufacturing Approval

FDA Approval
  • RxMP Therapeutics secured a Cooperative Research and Development Agreement with the Department of Defense's Institute of Surgical Research to validate RMP-402 in large animal models of polytrauma hemorrhage and shock.
  • The company reached consensus with the FDA on its GMP allogeneic manufacturing process for RMP-402, enabling large-scale production of the red cell-derived hemostatic agent.
  • RxMP appointed Shawna Khouri as Chief Operating Officer to oversee operational strategy for its injectable drug platform focused on hemostasis and bleeding management.

Axio BioPharma and Likarda Form Strategic Partnership to Integrate AI Manufacturing with Advanced Drug Delivery

Monoclonal Antibody
  • Axio BioPharma and Likarda announced a strategic partnership combining AI-powered protein manufacturing with advanced drug delivery technologies to accelerate biologic drug development timelines.
  • The collaboration integrates Likarda's Core-Shell Spherification® hydrogel technology for encapsulation and controlled release with Axio's discovery-to-GMP manufacturing capabilities.
  • The partnership aims to enhance workflows for monoclonal antibodies, bispecifics, and Fc-fusions while providing clients with more efficient and scalable paths to clinical manufacturing.
  • Both companies emphasize integrating delivery technologies earlier in the development process to improve stability, efficacy, and patient outcomes while reducing development friction.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.