相关临床试验
17
3 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2007
进行中（未招募）
3
17.6%
已完成
12
70.6%
招募中
2
11.8%
暂无批准数据
- Traws Pharma postponed its phase 2a human influenza challenge study of tivoxavir marboxil after receiving a negative regulatory review from the UK's MHRA. - The deferred trial was tied to $20 million in financing, with $10 million contingent on MHRA approval and $10 million linked to data readout. - The FDA separately placed the U.S. IND application on hold in January due to concerns about mutagenicity in the toxicology data package. - Traws is advancing backup antiviral candidates without mutagenic potential while maintaining a cash runway into Q1 2027.
- hVIVO has signed a contract to conduct the world's first pivotal Phase III human challenge trial for BPZE1, a whooping cough vaccine candidate developed by ILiAD Biotechnologies. - The company also secured a £6 million agreement to test a monoclonal antibody treatment for influenza in a randomized, double-blinded, placebo-controlled human challenge trial. - The whooping cough trial will involve more than 500 healthy volunteers and represents hVIVO's largest HCT to date, with revenue recognition expected across 2026 and 2027. - These contracts provide materially improved revenue visibility for 2026 and demonstrate the growing acceptance of human challenge trials for accelerating vaccine and drug development.
- Cardiometabolic disease encompasses a broad spectrum of interconnected disorders including diabetes, cardiovascular disease, fatty liver disease, and heart failure, requiring tailored trial designs for each specific indication. - Traditional placebo-controlled trials face increasing challenges due to patient retention difficulties, leading to adoption of adaptive designs, active comparator studies, and shorter trial durations of three to six months. - Early-phase cardiometabolic trials are shifting focus from weight loss alone to comprehensive biological endpoints that demonstrate meaningful pharmacodynamic evidence across metabolic, cardiovascular, and inflammatory pathways. - Regulatory agencies are beginning to accept innovative statistical methods including indirect placebo comparisons and adaptive trial designs to address operational and ethical challenges in long-term studies.
- The FDA has granted Orphan Drug Designation to POLB 001, an oral p38 MAP kinase inhibitor designed to prevent or treat cytokine release syndrome (CRS) induced by T-cell engager bispecific antibodies. - POLB 001 addresses a critical unmet medical need as CRS occurs in more than 70% of patients receiving certain cancer immunotherapies and currently has no approved preventative therapies. - The designation provides Poolbeg with potential seven-year market exclusivity, fee waivers, and tax credits, while strengthening the drug's commercial appeal for prospective partners. - Phase 2a clinical trials are expected to begin in H2 2025 with interim analysis in H1 2026, supported by Big Pharma interest in providing bispecific antibodies for the study.
- ILiAD Biotechnologies and hVIVO have signed a Letter of Intent to conduct a pivotal Phase 3 human challenge trial for ILiAD's BPZE1 pertussis vaccine. - The trial, anticipated to begin in H2 2025, will evaluate BPZE1, a next-generation intranasal vaccine, against whooping cough caused by *Bordetella pertussis*. - This landmark study marks the first Phase 3 trial using a human challenge model for pertussis, addressing the unpredictability of natural outbreaks. - BPZE1 aims to provide comprehensive and durable protection against *B. pertussis* infection and disease, potentially preventing transmission, including to infants.
- hLAB, a subsidiary of hVIVO, has signed a £2.7 million contract with a US-based biotechnology firm to support a Phase 2 influenza drug trial. - hLAB will serve as the sole virology lab for the international, multi-site study, analyzing samples from 5,000 subjects. - The contract, hLAB's largest to date, highlights the company's expansion into standalone laboratory services and field studies. - Revenue from the contract will be recognized primarily in 2025, with the remainder expected in 2026, bolstering hVIVO's growth strategy.
- hVIVO has successfully completed a pilot characterization study for its human metapneumovirus (hMPV) strain A2 challenge agent, demonstrating proof-of-concept. - The study exhibited a strong infectivity rate and induced symptomatic disease in healthy volunteers, confirming the viability of the hMPV human challenge model. - hVIVO is now marketing its hMPV challenge model to support the development of hMPV vaccines and antivirals, addressing a significant unmet medical need. - Data from the pilot study will be presented at the 13th International RSV Symposium in Brazil in March 2025.
• hVIVO's COVID-19 characterization trial identifies blood-based biomarkers distinguishing early and late-stage respiratory viral infections, including SARS-CoV-2. • The identified biomarkers could enhance the diagnosis and management of early and late-stage infections, potentially before PCR confirmation. • The study, published in Nature Communications, underscores the value of human challenge trials in understanding immune responses and accelerating drug development. • hVIVO's research supports the development of next-generation treatments for COVID-19 and other respiratory viruses, addressing limitations of current vaccines.
- Inhalon Biopharma is collaborating with hVIVO to conduct a Phase 2a human challenge trial for its antiviral candidate, IN-002, targeting respiratory syncytial virus (RSV). - The trial will assess the safety, pharmacokinetics, and antiviral activity of IN-002, an inhaled antibody treatment, using hVIVO's RSV human challenge model and FluCamp volunteer recruitment. - The study is scheduled to commence in the second half of 2025 in London, with revenue recognition expected in 2026, and will include three dosing arms to gain insights into the candidate's efficacy. - Inhalon's IN-002 aims to address the unmet need for effective RSV antivirals, offering a potentially painless, self-administered treatment option to reduce hospitalizations.
- Enanta Pharmaceuticals' EDP-323 demonstrated significant viral load reduction in a Phase 2a human challenge trial for Respiratory Syncytial Virus (RSV). - The study showed an 85-87% reduction in viral load and a 97-98% reduction in infectious viral load compared to placebo. - EDP-323 also significantly reduced total clinical symptoms by 66-78% and was generally safe and well-tolerated in healthy adults. - These results support EDP-323's potential as a once-daily oral treatment for RSV, with further data to be presented at a future conference.
