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NICE Approves Eladynos for Postmenopausal Osteoporosis, But NHS Diagnostic Gaps Pose Access Challenges

  • NICE has approved Eladynos (abaloparatide) for routine NHS use in postmenopausal women at high risk of osteoporotic fractures, potentially benefiting 14,000 patients in England.
  • The drug represents only the second osteoporosis treatment to reach UK patients in 15 years, offering an alternative to existing therapies Evenity and Forsteo.
  • Despite the approval, limited access to Fracture Liaison Services in half of NHS Trusts may prevent 90,000 patients from receiving new bone treatments like Eladynos.

4SC's Resminostat (Kinselby) MAA Under EMA Review for Advanced CTCL Maintenance Therapy

  • 4SC AG's Marketing Authorization Application (MAA) for resminostat (Kinselby) is under evaluation by the European Medicines Agency (EMA) for advanced Cutaneous T-Cell Lymphoma (CTCL).
  • The MAA is based on positive data from the pivotal RESMAIN study, which demonstrated that resminostat prolongs progression-free survival in CTCL patients.
  • 4SC anticipates addressing the EMA's questions by the end of 2024, with potential EU market authorization expected by mid-2025, pending approval.
  • 4SC is actively exploring licensing opportunities for Kinselby in the EU, UK, and Switzerland, aiming to provide a maintenance therapy option for CTCL patients.

Olema Oncology Reports Second Quarter 2024 Financial Results and Corporate Update

Olema Oncology has reported its second quarter 2024 financial results, highlighting promising interim clinical results from the study of palazestrant in combination with ribociclib, and the completion of IND-enabling studies for OP-3136. The company also provided updates on its financial status and upcoming milestones.

Advancements in Neuroplastogens, KRAS G12C Inhibitors, and Other Therapies Highlighted by Recent Deals and Clinical Readouts

  • Significant financial transactions in May 2024 advanced the development of next-generation neuroplastogens and KRAS G12C inhibitors, signaling strong investment in these areas.
  • Positive clinical readouts were reported for tetrameric transthyretin (TTR) stabilizers, showing promise in treating related conditions.
  • Advances in Pompe disease treatments and molecular glues also mark a period of intense activity and innovation in pharmaceutical research and development.

FDA Approves Vorasidenib (Voranigo) for IDH-Mutant Grade 2 Glioma

  • The FDA has approved vorasidenib (Voranigo) for adult and pediatric patients (12+) with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation.
  • Vorasidenib is a first-in-class oral inhibitor of isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) enzymes, offering a new treatment option for this patient population.
  • The approval was based on the Phase 3 INDIGO trial, which demonstrated a significant extension in progression-free survival compared to placebo (27.7 months vs. 11.1 months).
  • Common adverse reactions in the INDIGO trial included fatigue, COVID-19, musculoskeletal pain, diarrhea, and seizure, with the drug generally well-tolerated.

Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)

NCT04164901Active, Not RecruitingPhase 3
Institut de Recherches Internationales Servier
Posted 1/5/2020

XDEMVY: The First FDA-Approved Treatment for Demodex Blepharitis

XDEMVY is the first and only FDA-approved treatment specifically designed to combat Demodex blepharitis, a condition caused by an overpopulation of Demodex mites in eyelashes. Clinical trials have shown significant effectiveness in reducing symptoms and eradicating mites.

Elevation Oncology's EO-3021 Shows Promise in Claudin 18.2-Expressing Solid Tumors

  • EO-3021 demonstrates a 42.8% objective response rate in gastric and GEJ cancer patients with high Claudin 18.2 expression.
  • The antibody-drug conjugate exhibits a favorable safety profile, with minimal MMAE-associated toxicities, including no neutropenia or peripheral neuropathy.
  • Elevation Oncology plans to advance EO-3021 into the dose expansion phase of the Phase 1 trial and initiate combination studies.
  • Additional monotherapy data from the Phase 1 trial is expected in the first half of 2025, with combination dosing to begin by year-end 2024.

Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2

NCT05980416RecruitingPhase 1
Elevation Oncology
Posted 8/10/2023

High Rate of Disease Progression Observed in Low-Risk Myelofibrosis Patients

  • A significant 58.5% of patients with low- or intermediate-1–risk myelofibrosis experienced disease progression, highlighting the dynamic nature of the condition.
  • Anemia and thrombocytopenia were the most frequently observed criteria for disease progression, indicating potential biomarkers for monitoring.
  • The findings underscore the need for vigilant monitoring and the development of disease-modifying therapies for low-risk myelofibrosis patients.
  • Early detection of progression and symptom management are crucial, emphasizing the importance of close patient observation and intervention.

Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)

NCT02953704Completed
Incyte Corporation
Posted 12/31/2016

Intrinsic Medicine Advances Human Milk Oligosaccharides (HMOs) for Chronic Disease Treatment

  • Intrinsic Medicine is pioneering the use of human milk oligosaccharides (HMOs) to treat chronic diseases linked to immune dysregulation and microbiome dysbiosis.
  • The company's lead compound, 2’Fucosyllactose (2’FL), is entering a Phase 2 clinical trial in Australia for Parkinson's disease and irritable bowel syndrome (IBS).
  • Preclinical data suggest that another HMO, 3’Sialyllactose (3’SL), shows promise as a disease-modifying therapy for juvenile idiopathic arthritis and atopic dermatitis.
  • Intrinsic Medicine leverages the gut-immune-brain axis (GIBA) concept to target multifactorial disorders with inherently safe compounds.

Daiichi Sankyo and Merck Expand Collaboration to Develop Novel DLL3-Targeting T-Cell Engager for Small Cell Lung Cancer

  • Daiichi Sankyo and Merck have expanded their existing partnership to include MK-6070, an investigational DLL3-targeting T-cell engager, with Merck receiving $170 million upfront in the agreement.
  • MK-6070 targets delta-like ligand 3 (DLL3), which is highly expressed in small cell lung cancer and neuroendocrine tumors, and has received FDA Orphan Drug Designation for SCLC treatment.
  • The companies plan to evaluate MK-6070 in combination with ifinatamab deruxtecan (I-DXd) in patients with small cell lung cancer, addressing an aggressive cancer with significant unmet treatment needs.

A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001)

NCT04471727RecruitingPhase 1
Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Posted 12/14/2020
Oncology
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