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Clinical Trial News

NewAmsterdam's Obicetrapib Receives EMA Validation for European Review Following Positive Phase 3 Results

Drug Approval
  • The European Medicines Agency has validated Marketing Authorization Applications for obicetrapib monotherapy and obicetrapib-ezetimibe combination therapy, marking a significant regulatory milestone for NewAmsterdam Pharma.
  • Phase 3 trials demonstrated clinically meaningful LDL-C reductions of 35-40% with obicetrapib monotherapy and approximately 50% with the combination therapy, both showing safety profiles comparable to placebo.
  • The partnership with Menarini Group provides NewAmsterdam with potential milestone payments up to €863 million and tiered double-digit royalties, while Menarini handles European commercialization responsibilities.
  • With cardiovascular disease causing 17.9 million deaths annually and many patients failing to reach LDL-C targets despite existing therapies, obicetrapib could address a significant unmet medical need.

Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

NCT06005597CompletedPhase 3
NewAmsterdam Pharma
Posted 3/1/2024

Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.

NCT05425745CompletedPhase 3
NewAmsterdam Pharma
Posted 7/25/2022

Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

NCT05142722CompletedPhase 3
NewAmsterdam Pharma
Posted 12/15/2021

NanoViricides' NV-387 Antiviral Drug Shows Potential to Prevent Cancer Metastasis Resurgence Through Anti-Inflammatory Effects

  • NanoViricides reports that its broad-spectrum antiviral drug NV-387 could help reduce metastatic cancer resurgence by preventing viral infections from awakening dormant cancer cells.
  • The drug has completed Phase I clinical trials and is advancing to Phase II, demonstrating effectiveness against multiple respiratory viruses while reducing inflammatory cytokine IL-6 levels.
  • Recent studies have linked viral infections and increased IL-6 inflammation to higher risk of metastatic cancer resurgence, particularly in COVID-19 and breast cancer patients.
  • NV-387 outperformed approved antiviral drugs including Tamiflu, Rapivab, and Xofluza in animal studies, showing superior lung protection and anti-inflammatory effects.

IQVIA and Veeva Systems Form Strategic Partnership to Accelerate Clinical Development and Commercial Operations

AI
  • IQVIA and Veeva Systems announced global clinical and commercial partnerships on August 18, 2025, resolving all pending legal disputes between the companies.
  • The partnership enables seamless integration of both companies' software, data, and services, including IQVIA data in Veeva platforms and Veeva software in IQVIA clinical trials.
  • Customers will benefit from accelerated database builds, study locks, and data delivery through combined clinical data management and EDC programming expertise.
  • The collaboration aims to help pharmaceutical companies bring treatments to market more efficiently and improve patient access to medical innovations.

Unicycive Therapeutics Secures Patent Protection for UNI-494 Kidney Disease Treatment Through 2040

  • Unicycive Therapeutics received U.S. Patent 12,377,082 for UNI-494 to treat chronic kidney disease, extending intellectual property protection until 2040.
  • UNI-494 is a novel nicotinamide ester derivative that functions as a selective ATP-sensitive mitochondrial potassium channel activator, targeting mitochondrial dysfunction in kidney disease.
  • The drug has received FDA orphan drug designation for preventing delayed graft function in kidney transplant patients and completed Phase I safety studies in healthy volunteers.
  • Acute kidney injury affects an estimated 2 million deaths worldwide annually, with survivors at increased risk of developing chronic kidney disease and end-stage renal disease.

ASTER 70 Trial Shows No Survival Benefit from Adjuvant Chemotherapy in Elderly Breast Cancer Patients

  • The ASTER 70 phase III trial involving 1,089 patients aged 70 and older with high-risk ER+HER2- breast cancer found no significant overall survival benefit from adding chemotherapy to hormone therapy.
  • After 7.8 years of follow-up, four-year survival rates were 90.5% with chemotherapy versus 89.3% with hormone therapy alone, while eight-year rates were 72.7% versus 68.3% respectively.
  • Patients receiving chemotherapy experienced significantly more grade 3 or higher adverse events (34% versus 9%) and reported worse quality of life including increased fatigue, pain, and digestive disorders.
  • The findings challenge current treatment standards and support more individualized approaches for elderly breast cancer patients based on age, frailty, and patient preferences rather than tumor biology alone.

Adjuvant Systemic Treatment for (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment

NCT01564056Active, Not RecruitingPhase 3
UNICANCER
Posted 4/12/2012

Phase III IMvigor011 Trial Demonstrates Significant Survival Benefits for ctDNA-Guided Bladder Cancer Treatment

Precision Medicine
  • The randomized phase III IMvigor011 trial achieved positive topline results, showing statistically significant and clinically meaningful improvements in disease-free survival and overall survival for Signatera-positive muscle-invasive bladder cancer patients treated with atezolizumab.
  • This represents the first prospective phase III study in muscle-invasive bladder cancer to use a personalized, ctDNA molecular residual disease-guided approach for treatment selection.
  • Signatera-negative patients demonstrated excellent outcomes without adjuvant treatment, with 100% overall survival at 12 months and 98% at 18 months.
  • Natera plans to finalize its premarket approval application to the FDA for Signatera as a companion diagnostic for selecting MIBC patients for atezolizumab treatment after cystectomy.

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

NCT04008030Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 8/5/2019

Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3)

NCT03377491CompletedPhase 3
NovoCure Ltd.
Posted 2/10/2018

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

NCT05280470Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 3/9/2022

A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy

NCT04660344Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 5/3/2021

Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors

NCT04145622RecruitingPhase 1
Daiichi Sankyo
Posted 11/3/2019

Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)

NCT04886804RecruitingPhase 1
Boehringer Ingelheim
Posted 7/2/2021

Outlook Therapeutics Awaits Critical FDA Decision for Wet AMD Treatment ONS-5010

Drug Approval
  • Outlook Therapeutics' stock surged 11.97% in pre-market trading on August 18, 2025, as investors anticipate the FDA's decision on ONS-5010 (LYTENAVA) scheduled for August 27, 2025.
  • The investigational ophthalmic formulation of bevacizumab represents the company's second attempt at FDA approval after initial rejection in August 2023 due to chemistry, manufacturing, and controls issues.
  • ONS-5010 has already received European approval in May 2024 for wet age-related macular degeneration treatment and would receive 12 years of regulatory exclusivity if approved in the United States.
  • The company resubmitted its Biologics License Application in February 2025, addressing FDA concerns from the Complete Response Letter issued after the initial rejection.

FDA Grants Breakthrough Therapy Designation to Bristol Myers Squibb and SystImmune's Iza-bren for Advanced EGFR-Mutant Lung Cancer

  • The FDA has granted breakthrough therapy designation to iza-bren, a first-in-class bispecific antibody-drug conjugate developed by Bristol Myers Squibb and SystImmune for treating advanced EGFR-mutant lung cancer.
  • The designation applies to patients with locally advanced or metastatic non-small cell lung cancer harboring specific EGFR mutations whose disease has progressed after standard treatments.
  • The FDA decision was based on data from three ongoing clinical trials conducted across China, the United States, Europe, and Japan.
  • Iza-bren represents a potential new treatment option for patients with EGFR-mutant lung cancer who have exhausted current therapeutic options.

A Study of BL-B01D1 and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

NCT05880706Active, Not RecruitingPhase 2
Sichuan Baili Pharmaceutical Co., Ltd.
Posted 7/19/2023

A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor

NCT05194982RecruitingPhase 1
Sichuan Baili Pharmaceutical Co., Ltd.
Posted 11/29/2021

Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors

NCT05983432RecruitingPhase 1
SystImmune Inc.
Posted 8/8/2023

Anocca Secures $46M to Advance Europe's First Non-Viral Gene-Edited TCR-T Therapy for Pancreatic Cancer

Gene Editing
  • Anocca AB raised SEK 440 million ($46 million) in financing led by Mellby Gård to advance VIDAR-1, Europe's first non-viral gene-edited TCR-T cell therapy targeting pancreatic cancer.
  • The Phase I multi-center trial is now recruiting patients across eight sites in Sweden, Denmark, Germany, and The Netherlands, targeting mutant KRAS in pancreatic ductal adenocarcinoma.
  • VIDAR-1 represents a breakthrough approach for pancreatic cancer patients, who face a five-year survival rate of less than 10% with limited definitive treatment options currently available.
  • The funding will support early-stage clinical development of VIDAR-1 and advance Anocca's preclinical pipeline of TCR-T therapies for solid tumors and other difficult-to-treat diseases.

FDA Releases White Paper on Selective Safety Data Collection Framework for Late-Stage Clinical Trials

Oncology
  • The FDA's Center for Clinical Trial Innovation has published a white paper outlining its regulatory framework for selective safety data collection (SSDC) in late-stage clinical trials for drugs with well-characterized safety profiles.
  • The SSDC approach allows for planned reduction in collecting certain safety data types, including common non-serious adverse events and routine laboratory assessments, when such data is unlikely to provide additional clinically important knowledge.
  • Real-world examples demonstrate successful implementation across therapeutic areas, including the Pragmatica-Lung Study which limited safety collection to grade 3+ adverse events and the VICTORION-2-PREVENT study which reduced visit frequency from monthly to every 6 months.
  • The framework promises to reduce participant burden, lower study costs, and accelerate drug development while maintaining patient safety standards, though adoption remains limited despite international regulatory harmonization.

Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

NCT05030428Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 11/23/2021

Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study

NCT05633602Active, Not RecruitingPhase 3
SWOG Cancer Research Network
Posted 3/14/2023

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