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Clinical Trial News

Large Real-World Study Finds No Increased Cancer or Cardiovascular Risk with JAK Inhibitors in Rheumatoid Arthritis

Real World Evidence
  • A comprehensive analysis of 53,169 treatment initiations across 13 international registries found no significantly higher cancer risk in rheumatoid arthritis patients treated with JAK inhibitors compared to biologic DMARDs.
  • Separate cardiovascular safety data from 51,233 patients showed JAK inhibitors did not increase major adverse cardiovascular events compared to TNF inhibitors, with rates of 6.97 versus 7.57 per 1,000 person-years respectively.
  • The findings provide reassuring real-world evidence addressing previous safety concerns raised by the ORAL Surveillance trial, though increased keratinocyte cancer risk remains a consideration for JAK inhibitor therapy.
  • GLP-1 receptor agonists showed potential cardioprotective effects in RA patients on JAK inhibitors, with significantly lower rates of acute coronary syndromes and deep venous thrombosis.

Mitsubishi Research Institute and Astellas Partner to Accelerate Japanese Drug Discovery Startups

Drug DiscoveryDrug Discovery
  • Mitsubishi Research Institute and Astellas Pharma have signed a memorandum of understanding to support Japanese drug-discovery startups in their global expansion efforts.
  • The collaboration operates under Japan's Ministry of Health, Labour and Welfare's Medical Innovation Support Office (MEDISO), which has supported over 1,200 startup and academic ventures since 2018.
  • Participating startups will gain access to laboratory and office space at Astellas' SakuLab-Tsukuba facility, along with expert consultations and networking opportunities with Astellas researchers.
  • The initiative aims to strengthen Japan's position as a global drug discovery hub and address the gap between advanced life-sciences technologies and their practical application.

Merry Life Advances First-in-Class Alzheimer's Drug TML-6 to Global Phase II Trial

  • Merry Life Biomedical has launched a global Phase II clinical trial for TML-6, the first drug targeting the autolysosome pathway for Alzheimer's disease treatment.
  • The novel oral small molecule combines multiple mechanisms including anti-oxidative effects, autophagy function improvement, and anti-amyloid accumulation through a multi-target strategy.
  • The 12-month Phase II study will enroll 210 patients with mild cognitive impairment or mild dementia across 19 sites in the United States, Sweden, and Taiwan.
  • Phase I trials demonstrated excellent safety, tolerability, and pharmacokinetics at 100-200 mg doses in both healthy and elderly adults.

Quince Therapeutics Secures Up to $22 Million to Advance Phase 3 Ataxia-Telangiectasia Trial

Rare Disease
  • Quince Therapeutics raised $11.5 million in upfront proceeds with potential for an additional $10.4 million through warrant exercises to fund operations into 2026.
  • The financing will primarily support enrollment in the company's pivotal Phase 3 NEAT clinical trial evaluating eDSP for Ataxia-Telangiectasia treatment.
  • Healthcare-focused institutional investor Nantahala Capital led the private placement, with participation from existing stockholders and company management.
  • The securities were priced at a 10% premium to the previous closing price, reflecting investor confidence in the rare disease-focused biotechnology company.

Evaluate the Neurological Effects of EryDex on Subjects With A-T

NCT06193200Active, Not RecruitingPhase 3
Quince Therapeutics S.p.A.
Posted 6/24/2024

Viz.ai Receives First FDA Clearance for AI-Powered Subdural Hemorrhage Measurement Technology

AI
  • Viz.ai has received FDA 510(k) clearance for Viz Subdural Plus, the first comprehensive AI solution for quantifying subdural hemorrhages on CT scans.
  • The technology automatically measures volume, thickness, and midline shift of subdural collections, streamlining what has traditionally been a manual process.
  • Chronic subdural hematoma is projected to become the most common cranial neurosurgical condition, with approximately 60,000 new cases annually by 2030.
  • The AI tool is particularly valuable for guiding treatment decisions in elderly patients and those on anticoagulants, especially for MMA embolization procedures.

Prolaris Genomic Test Advances Personalized Prostate Cancer Treatment with Precision Therapy Selection

  • Prolaris genomic biomarker platform provides uniquely actionable clinical information that quantifies the absolute benefit of androgen deprivation therapy when added to radiation therapy for prostate cancer patients.
  • The clinical cell-cycle risk (CCR) score enables more nuanced assessments of metastasis risk and treatment intensification strategies beyond traditional NCCN risk groupings.
  • Emerging genomic risk stratification tools are transforming personalized prostate cancer treatment by offering clinicians more precise tools for treatment decision-making.

Innovent to Present Phase 3 Results of Dual GLP-1/Glucagon Receptor Agonist Mazdutide at ADA 2025

  • Innovent Biologics will present results from the first Phase 3 trial of mazdutide (DREAMS-1) in Chinese adults with type 2 diabetes at the American Diabetes Association's 85th Scientific Sessions.
  • Mazdutide, a dual GLP-1R and GCGR agonist developed under license from Eli Lilly, has demonstrated benefits beyond traditional GLP-1 receptor agonists by also activating glucagon receptors to increase energy expenditure.
  • The company currently has two New Drug Applications under regulatory review by NMPA for mazdutide, covering long-term weight management and glycemic control in type 2 diabetes.
  • Multiple exploratory studies will showcase mazdutide's mechanism of action, including effects on liver fat accumulation, MASH fibrosis, and hyperuricemia reduction.

A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

NCT05628311CompletedPhase 3
Innovent Biologics (Suzhou) Co. Ltd.
Posted 1/6/2023

A Study of IBI362 in Participants With Type 2 Diabetes

NCT05606913CompletedPhase 3
Innovent Biologics (Suzhou) Co. Ltd.
Posted 1/6/2023

Early Colorectal Cancer Screening at Age 40 Reduces Death Risk by 39%, Taiwan Study Shows

  • A Taiwan study of 263,125 adults found that starting fecal immunochemical test (FIT) screening at ages 40-49 reduced colorectal cancer mortality by 39% and incidence by 21% compared to beginning at age 50.
  • Early screeners had significantly lower cancer rates (26.1 vs 42.6 cases per 100,000 person-years) and mortality rates (3.2 vs 7.4 deaths per 100,000 person-years) than those who started screening at age 50.
  • The findings support lowering screening initiation age as colorectal cancer incidence in adults under 50 has been increasing by 3% annually since the early 2010s.
  • A separate US study demonstrated that mailed FIT kits achieved 26.2% screening participation rates in adults aged 45-49, significantly higher than active choice approaches.

GenSight Biologics Secures French Regulatory Pathway for LUMEVOQ Gene Therapy in Rare Blindness Disease

Rare Disease
  • GenSight Biologics reached agreement with French regulatory agency ANSM to expedite opening of early access program for LUMEVOQ gene therapy following approval of a dose-ranging study.
  • The company targets Q3 2025 for clinical trial application submission and Q4 2025 for program launch, providing treatment access for LHON patients in France.
  • GenSight plans global Phase III trial initiation in early H2 2026 while implementing financing strategy to bridge operations through regulatory milestones.
  • The agreement represents a critical pathway for patients with Leber Hereditary Optic Neuropathy, a rare mitochondrial disease causing irreversible blindness in young adults.

NHS Becomes First Health System Globally to Approve 'Trojan Horse' Cancer Therapy for Multiple Myeloma

Drug ApprovalTargeted TherapyOncology
  • The NHS in England has become the first health system worldwide to approve belantamab mafodotin (Blenrep), a novel antibody-drug conjugate therapy for multiple myeloma patients.
  • Clinical trials demonstrated the treatment delayed disease progression by an average of three years compared to just over one year with standard daratumumab therapy.
  • Approximately 1,500 patients annually with relapsed or refractory multiple myeloma will be eligible for this targeted therapy through the NHS Cancer Drugs Fund.
  • The "Trojan horse" mechanism allows the drug to infiltrate cancer cells and release lethal molecules from within, representing a significant advancement in myeloma treatment.

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