MedPath

Clinical Trial News

Failed Long COVID Drug Trial Reveals Critical Study Design Flaws as New Company Plans Restart

  • Berlin Cures' Phase 2 trial of BC 007 (rovunaptabin) for long COVID failed in November 2024 due to poor patient selection and inadequate outcome measures, despite some participants experiencing dramatic symptom improvements.
  • A separate smaller trial at University Hospital Erlangen found significant improvements in fatigue and post-exertional malaise using more targeted selection criteria and validated ME assessment tools.
  • Former Berlin Cures CEO Oliver von Stein has launched APTA Therapeutics to acquire the drug's assets and plans new studies within 18 months, focusing on better patient stratification and collaboration with long COVID experts.

Lantheus Completes $789 Million Acquisition of Life Molecular Imaging, Gains FDA-Approved Alzheimer's Diagnostic Agent

Drug Approval
  • Lantheus Holdings completed its $789 million acquisition of Life Molecular Imaging on July 22, 2025, gaining access to Neuraceq, an FDA-approved F-18 PET imaging agent for detecting beta-amyloid plaques in Alzheimer's disease patients.
  • The transaction provides Lantheus with robust Alzheimer's disease radiodiagnostic commercial infrastructure, advanced R&D capabilities, and an established international footprint across multiple markets.
  • Former Life Molecular Imaging CEO Dr. Ludger Dinkelborg joined Lantheus as Head of Research and Development on August 1, 2025, bringing proven leadership in advancing innovative radiopharmaceuticals.
  • Neuraceq received FDA approval on June 23, 2025, for positron emission tomography of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment.

Eli Lilly Advances LOXO-435 in Phase 1 FORAGER-1 Study for FGFR3-Altered Advanced Cancers

Targeted TherapyOncology
  • Eli Lilly's FORAGER-1 Phase 1 study is evaluating LOXO-435 (LY3866288) as both monotherapy and combination treatment for locally advanced or metastatic solid tumors with FGFR3 gene alterations.
  • The open-label, multicenter trial tests the oral drug alone and in combination with pembrolizumab and enfortumab vedotin to determine optimal dosage and assess safety and efficacy.
  • The study began January 12, 2023, with primary completion date yet to be announced, representing a potential advancement in targeted cancer therapy for FGFR3-altered tumors.
  • Success in this study could enhance Eli Lilly's competitive position in the oncology market and potentially impact the company's stock performance positively.

Longeveron Licenses Novel Cardiac Stem Cell Technology to Address Safety Concerns in Heart Disease Treatment

  • Longeveron has licensed US Patent 12,168,028 B2 from the University of Miami, protecting unique GHRH-Receptor+ cardiomyogenic cells derived from induced pluripotent stem cells.
  • The new technology addresses a critical safety barrier in cardiac stem cell therapy by eliminating cells that cause malignant ventricular arrhythmias, a complication that has slowed clinical development.
  • This advancement expands Longeveron's stem cell therapy pipeline beyond their current programs in hypoplastic left heart syndrome, Alzheimer's disease, and pediatric dilated cardiomyopathy.
  • The technology has potential applications across a broad range of cardiovascular diseases in both adult and rare pediatric populations.

HIV Drugs Show Promise as First Prophylactic Treatment for HTLV-1 Virus in Landmark Australian Study

  • Australian researchers have identified the first potential prophylactic treatment for HTLV-1, a neglected virus affecting 10 million people globally, using existing HIV antivirals tenofovir and dolutegravir in humanized mouse models.
  • The study marks the first time any research group has successfully suppressed HTLV-1 transmission in a living organism, with both drugs showing powerful suppression against international and Australian virus strains.
  • Combination therapy using HIV antivirals with MCL-1 protein inhibitors demonstrated the ability to selectively kill HTLV-1-infected cells, suggesting a potential curative strategy for established infections.
  • The research team is now in discussions with pharmaceutical companies to include HTLV-1 patients in ongoing HIV drug clinical trials, potentially leading to the first approved pre-exposure prophylaxis for this life-threatening virus.

DualityBio's HER3-Targeting ADC DB-1310 Receives FDA Fast Track Designation for EGFR-Mutant Lung Cancer

  • DualityBio's next-generation HER3-targeting antibody-drug conjugate DB-1310 has received FDA Fast Track Designation for treating advanced nonsquamous non-small cell lung cancer with EGFR mutations.
  • The designation specifically covers patients with EGFR exon 19 deletion or L858R mutation who have progressed after treatment with third-generation EGFR tyrosine kinase inhibitors and platinum-based chemotherapy.
  • Phase I/IIa clinical trial data presented at ASCO 2025 demonstrated encouraging efficacy and manageable safety profile in patients with advanced solid tumors who had failed standard therapies.
  • DB-1310 is developed using DualityBio's proprietary DITAC platform and has shown robust synergistic tumor suppression activity in preclinical combination studies with EGFR TKIs.

A Study of DB-1310 in Advanced/Metastatic Solid Tumors

NCT05785741RecruitingPhase 1
DualityBio Inc.
Posted 4/10/2023

AstraZeneca Announces $50 Billion US Investment Plan with Virginia Manufacturing Hub for Weight Management and Metabolic Drugs

  • AstraZeneca announces a $50 billion investment in the United States by 2030, with Virginia selected as the site for the company's largest single manufacturing facility investment globally.
  • The new multi-billion dollar Virginia facility will produce drug substances for AstraZeneca's weight management and metabolic portfolio, including oral GLP-1, baxdrostat, oral PCSK9, and combination small molecule products.
  • The investment is expected to create tens of thousands of highly skilled direct and indirect jobs across the country and support AstraZeneca's ambition to reach $80 billion in revenue by 2030.
  • The comprehensive investment plan includes expansion of R&D facilities in Maryland and Massachusetts, next-generation manufacturing sites for cell therapy, and continuous manufacturing expansion across multiple states.

CASI Pharmaceuticals Names David Cory CEO to Advance Anti-CD38 Antibody CID-103 Program

Monoclonal AntibodyLeadership Change
  • CASI Pharmaceuticals appointed industry veteran David Cory as CEO to lead the U.S. operations and focus on advancing CID-103, a potential best-in-class anti-CD38 monoclonal antibody.
  • CID-103 is currently dosing patients in a multi-center Phase 1/2 study for chronic immune thrombocytopenia (ITP) and has an IND application filed for renal allograft antibody-mediated rejection.
  • Cory brings over 30 years of biotech experience, having raised over $1 billion in capital markets and led multiple company exits totaling approximately $9 billion in acquisitions.
  • The leadership change positions CASI to concentrate resources on maximizing the therapeutic potential of CD38 targeting for organ transplant rejection and autoimmune diseases.

FDA Clears Takeda's HyHub Devices to Streamline At-Home HYQVIA Immunoglobulin Therapy

Drug Approval
  • The FDA has granted 510(k) clearance to Takeda's HyHub and HyHub Duo devices, which enable needle-free transfer of HYQVIA's dual-vial components for patients aged 17 and older.
  • The devices reduce preparation steps by up to 50% compared to traditional pooling bag methods and minimize the need for ancillary supplies during infusion preparation.
  • HYQVIA is approved for treating primary immunodeficiency in adults and children as young as two, and as maintenance therapy for chronic inflammatory demyelinating polyneuropathy in adults.
  • The devices will be available at no additional cost to patients starting in the second half of fiscal year 2025, with a CE Mark application under review in the European Union.

A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

NCT02549170CompletedPhase 3
Baxalta now part of Shire
Posted 12/15/2015

Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP

NCT02955355CompletedPhase 3
Baxalta now part of Shire
Posted 11/14/2016

Livzon's Dual-Target IL-17A/F Antibody LZM012 Outperforms Secukinumab in Phase III Psoriasis Trial

Monoclonal Antibody
  • Livzon Pharmaceutical's LZM012, the first domestic dual-target IL-17A/F monoclonal antibody, achieved superior efficacy compared to Secukinumab in a Phase III trial for moderate to severe plaque psoriasis.
  • The study demonstrated LZM012's 49.5% PASI 100 response rate at week 12 versus 40.2% for Secukinumab, with faster onset of action and sustained benefits through 52 weeks.
  • LZM012 showed good overall safety profile with adverse event rates comparable to the control group, and Livzon has submitted pre-market communication to China's NMPA for regulatory approval.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.