HVIVO SERVICES LIMITED

ILiAD and hVIVO Partner for Phase 3 Human Challenge Trial of BPZE1 Pertussis Vaccine

4 months ago

• 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.

hVIVO Identifies Key COVID-19 Biomarkers in Human Challenge Study

5 months ago

• 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 and hVIVO Partner for RSV Human Challenge Trial of IN-002

5 months ago

• 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's EDP-323 Shows Strong Efficacy in RSV Human Challenge Trial

8 months ago

• 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.

Patient-Centric Websites and Plain Language Key to Boosting Clinical Trial Recruitment

6 years ago

• Clinical trial recruitment faces persistent challenges due to low participation rates, with trials often failing before completion due to insufficient enrollment. • Companies are revolutionizing trial recruitment by developing patient-friendly websites with plain language information, improved accessibility, and enhanced search engine optimization. • Industry expert Thomas Wicks highlights how transparent communication and cross-company collaboration in trial referrals are creating more opportunities for patient participation.