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Clinical Trial News

FDA Study Links Asthma Drug Montelukast to Neuropsychiatric Effects

  • An FDA study reveals that montelukast, commonly known as Singulair, significantly binds to brain receptors crucial for psychiatric function.
  • The research indicates montelukast can penetrate the brain, accumulating in regions associated with psychiatric effects, raising concerns about its impact.
  • Following numerous reports of neuropsychiatric episodes, the FDA added a black box warning in 2020, highlighting potential mental health risks like suicidal thoughts.
  • Scientists emphasize the need for further studies to understand how montelukast's brain binding leads to adverse effects and to identify at-risk individuals.

European Drug Shortages Hit Record Levels: Norway and Generics Most Affected

  • European pharmaceutical markets face unprecedented drug shortages in 2023-2024, driven by inflation, high operating costs, and rigid pricing systems, with Norway reporting 58% of total shortages across seven analyzed countries.
  • Generic medications are experiencing the most severe supply disruptions, with 11% of affected active ingredients reporting shortages in four or more European markets simultaneously.
  • Nervous system medications, particularly analgesics and psycholeptics, represent 25% of shortage-affected products, prompting various European governments to implement flexible pricing policies and regulatory adjustments.

Neurotech Receives Approval to Commence Human Pharmacokinetic Study of NTI164

  • Neurotech has received ethics approval to begin a human pharmacokinetic study of its drug NTI164 in Adelaide.
  • NTI164, an oral cannabinoid drug, is being developed for neurological disorders involving neuroinflammation.
  • The study aims to assess how the body processes NTI164, crucial for determining optimal dosage and efficacy.
  • This approval marks a significant step forward in Neurotech's clinical development program for NTI164.

Hanmi's BH3120 Shows Promise in Phase 1 Trials for Advanced Solid Tumors

  • Hanmi Pharmaceutical's BH3120, a novel dual-targeting antibody, is progressing through Phase 1 trials, showing no dose-limiting toxicities in advanced solid tumor patients.
  • The ongoing trial assesses BH3120 as a monotherapy and in combination with pembrolizumab (KEYTRUDA) for safety and tolerability in metastatic solid tumors.
  • Preclinical data suggests BH3120's unique mechanism may offer improved efficacy and safety compared to other 4-1BB-targeting antibodies, potentially overcoming prior limitations.
  • Hanmi's Pentambody platform underpins BH3120's design, enabling simultaneous binding to PD-L1 on cancer cells and 4-1BB on immune cells for enhanced anti-tumor activity.

Vagus Nerve Stimulation Shows Promise as 'Neural Tourniquet' to Reduce Surgical Bleeding

  • Researchers are developing a 'neural tourniquet' that uses vagus nerve stimulation to enhance blood clotting and reduce bleeding during surgery and postpartum.
  • Electrical stimulation of the vagus nerve activates immune cells in the spleen, preparing platelets to respond more effectively to injuries and reduce blood loss.
  • Clinical trials are underway to assess the efficacy of vagus nerve stimulation in healthy subjects, with preclinical data showing up to a 75% reduction in traumatic blood loss.
  • This proactive approach could revolutionize surgical practices by preventing excessive bleeding, potentially decreasing maternal deaths and surgical complications.

Effective Sponsor Oversight Critical for CRO Partnerships in Clinical Trials, Industry Leaders Emphasize

• Clinical trial sponsors and CROs must establish optimal oversight balance, with experts warning that both excessive and insufficient monitoring can impede trial success and efficiency.
• Industry leaders at Veeva's Clinical Operations Outsourcing 2024 Forum stress the importance of early collaboration agreements and transparent communication between sponsors and CROs.
• As clinical trials become increasingly complex, particularly in specialized therapies, the need for efficient sponsor oversight becomes more crucial for ensuring trial quality and regulatory compliance.

Cassava Sciences Announces Corporate Update on Alzheimer's Drug Simufilam

  • Cassava Sciences will hold a conference call and webcast on November 25th to provide a corporate update.
  • The update will likely cover the ongoing Phase 3 clinical trials of Simufilam for Alzheimer's disease.
  • Simufilam is an investigational oral small molecule drug targeting filamin A protein.
  • Cassava Sciences owns worldwide rights to Simufilam and related technologies.

Neurotech International Advances NTI164 Drug Trials with Ethics Approval for Pharmacokinetic Study

  • Neurotech International has secured ethics approval to commence a pharmacokinetic study of NTI164 in healthy adults, a crucial step for regulatory compliance.
  • The study will provide essential data on the drug's metabolism and excretion, supporting its development for neurological disorders.
  • This advancement marks significant progress in Neurotech's clinical trials and regulatory efforts for NTI164 in the U.S. and Australia.

Innovent Highlights Promising Clinical Data on Novel Oncology Molecules at ESMO Asia 2024

  • Innovent Biologics is set to present clinical data on multiple novel oncology molecules at the ESMO Asia Congress 2024, showcasing its commitment to innovative cancer therapies.
  • Updated Phase 1 results of IBI343, a TOPO1i CLDN18.2 ADC, will be presented, demonstrating encouraging efficacy and safety in previously-treated pancreatic cancer patients.
  • Additional studies feature combinations of sintilimab with chemotherapy and other agents, targeting various cancers including colorectal, liver, and non-small cell lung cancer.
  • Innovent's robust pipeline and advanced technology platforms in immuno-oncology and antibody-drug conjugates aim to transform cancer treatment options for patients worldwide.

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