Clinical Trial News
Acadia Pharmaceuticals Presents Real-World Data on DAYBUE™ (trofinetide) for Rett Syndrome
Acadia Pharmaceuticals Inc. announced interim data from the LOTUS™ study, evaluating the efficacy and tolerability of DAYBUE™ (trofinetide) in Rett syndrome patients, at the 2024 International Rett Syndrome Foundation Annual Scientific Meeting. The study highlights improvements in symptoms and caregiver strategies for managing gastrointestinal tolerability.
Arch Biopartners Receives Ethics Approval for Phase II Trial of LSALT Peptide in Calgary
Arch Biopartners Inc. has announced that the University of Calgary’s Conjoint Health Research Ethics Board has approved a Phase II trial for LSALT peptide, aimed at preventing and treating cardiac surgery-associated acute kidney injury (CS-AKI). The trial, which is also recruiting patients in Turkey, seeks to evaluate the effectiveness of LSALT peptide in reducing AKI incidents post-cardiac surgery.
Johnson & Johnson Seeks FDA Approval for Subcutaneous Amivantamab in NSCLC
- Johnson & Johnson has submitted a BLA to the FDA for a subcutaneous formulation of amivantamab for NSCLC treatment.
- The application includes a fixed formulation of amivantamab and recombinant human hyaluronidase for SC administration.
- The submission is based on the Phase III PALOMA-3 trial, which showed comparable efficacy to intravenous amivantamab.
- SC amivantamab offers a faster, approximately five-minute administration, potentially transforming the patient experience.
Oncology Dominates Planned and Expected Clinical Trials in 2024
- Oncology leads as the top therapy area for both planned and expected clinical trials in 2024, indicating a strong focus on cancer research and development.
- Phase II trials are the most prevalent among planned trials for 2024, with a majority sponsored by industry players like Novartis.
- The Asia-Pacific region is expected to see the most trial completions in 2024, with non-industry sponsors, such as the University of Texas MD Anderson Cancer Center, leading the efforts.
Cerevel Therapeutics Advances Emraclidine Development for Alzheimer's-Related Dementia and Psychosis
- Cerevel Therapeutics is developing Emraclidine (CVL-231), a novel oral M4 muscarinic receptor positive allosteric modulator, for treating dementia and psychosis in Alzheimer's disease.
- The drug candidate represents a potential breakthrough in addressing neuropsychiatric symptoms of Alzheimer's disease, targeting the muscarinic acetylcholine receptor M4 through a unique mechanism of action.
- As a subsidiary of AbbVie Inc., Cerevel is expanding its neuroscience portfolio, with Emraclidine development programs spanning multiple neurological conditions including schizophrenia and Alzheimer's-related disorders.
FDA Approves Merck's CAPVAXIVE: First 21-Serotype Pneumococcal Vaccine Designed Specifically for Adults
- The FDA has approved Merck's CAPVAXIVE, a novel 21-valent pneumococcal conjugate vaccine specifically designed to protect adults against serotypes causing the majority of invasive pneumococcal disease.
- CAPVAXIVE includes eight unique serotypes not covered by other approved pneumococcal vaccines, targeting approximately 84% of invasive pneumococcal disease cases in adults over 50, compared to 52% covered by PCV20.
- The single-dose vaccine demonstrated robust immunogenicity across various adult populations, with the CDC's Advisory Committee on Immunization Practices expected to make recommendations for its use later this month.
Highlighted Clinical Trials:
Merck Sharp & Dohme LLC
Posted 7/13/2022
Merck Sharp & Dohme LLC
Posted 7/12/2022
Merck Sharp & Dohme LLC
Posted 9/23/2022
Merck's Keytruda Advances Development Program for Hepatocellular Carcinoma Treatment
- Pembrolizumab (Keytruda) is being evaluated for both first-line and second-line treatment of hepatocellular carcinoma, expanding its potential role in liver cancer therapy.
- The drug, already approved for multiple cancer indications, has demonstrated significant clinical potential in HCC patients previously treated with sorafenib.
- Merck's development program for Keytruda in HCC represents a major advancement in immunotherapy options for liver cancer patients, addressing a significant unmet medical need.
PharmaMar's Trabectedin Expands Development Portfolio with Multiple Cancer Indications
- Trabectedin (Yondelis), a marine-derived antitumor agent, is currently approved for advanced soft tissue sarcoma and relapsed platinum-sensitive ovarian cancer in combination therapy.
- The drug is undergoing development for multiple new indications including mesenchymal chondrosarcoma, recurrent meningioma, and various gynecological cancers, expanding its therapeutic potential.
- PharmaMar continues to investigate Trabectedin's applications, building on its success in treating liposarcoma and leiomyosarcoma patients who have received prior anthracycline-containing regimens.
Roche's Bevacizumab Under Evaluation for Endometrial Cancer Treatment
- F. Hoffmann-La Roche is advancing bevacizumab as a potential therapeutic option for endometrial cancer, expanding the drug's application in gynecologic oncology.
- The development program leverages Roche's extensive experience in biotechnology and oncology, with the company tracking phase transition and likelihood of approval metrics based on 18 years of historical data.
- The assessment of bevacizumab for endometrial cancer considers multiple factors including drug attributes, company capabilities, and clinical trial design to determine potential approval success.
argenx Outlines 'Vision 2030' with Focus on Autoimmune Disease Therapies
- argenx will present its 'Vision 2030' at its R&D Day, focusing on expanding its reach to 50,000 patients with severe autoimmune diseases.
- The company plans to broaden its leadership in myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) with VYVGART and empasiprubart.
- Phase 2 data in Sjogren’s disease and multifocal motor neuropathy (MMN) support the advancement of efgartigimod and empasiprubart to Phase 3 development.
- argenx has decided not to advance efgartigimod in PC-POTS after Phase 2 results showed no clinically meaningful improvement compared to placebo.