Inhalon Biopharma, in collaboration with hVIVO, is set to initiate a Phase 2a human challenge trial for IN-002, an innovative inhaled antibody treatment targeting respiratory syncytial virus (RSV). The study, leveraging hVIVO's established RSV human challenge model and FluCamp volunteer recruitment, aims to evaluate the safety, pharmacokinetics, and antiviral activity of IN-002.
Trial Design and Objectives
The randomized, double-blinded, placebo-controlled trial will commence in the second half of 2025 at hVIVO's quarantine facility in Canary Wharf, London. Revenue from the contract is expected to be recognized across FY25 and FY26. The study will involve healthy volunteers intentionally exposed to RSV to assess the efficacy of IN-002. Notably, the trial includes three dosing arms, reflecting a growing trend among biopharmaceutical companies to gather more actionable insights early in clinical development.
IN-002: An Inhaled Antibody Approach
IN-002 represents a novel approach to combating RSV infections through direct inhaled delivery of antibodies into the lungs. This method aims to provide a more effective and convenient treatment option compared to traditional intravenous or intramuscular administrations. Inhalon Biopharma emphasizes the potential for self-administration at home, which could significantly reduce hospitalizations and healthcare costs.
Addressing Unmet Needs in RSV Treatment
Despite recent approvals of RSV vaccines, a considerable unmet need remains for effective antiviral treatments, particularly for vulnerable populations such as infants, toddlers, and the elderly. Current projections suggest that RSV vaccine adoption will only reach 35% of original estimates, highlighting the importance of alternative therapeutic strategies. RSV affects an estimated 33 million people globally each year, leading to approximately 4 million hospitalizations and 101,000 deaths in children under five years of age.
hVIVO's Role and Expertise
hVIVO, a contract research organization specializing in human challenge trials, will conduct the study utilizing its state-of-the-art quarantine facility and volunteer recruitment capabilities. Yamin 'Mo' Khan, CEO of hVIVO, stated that the contract demonstrates the trust and confidence that leading pharmaceutical companies place in hVIVO's human challenge study models. hVIVO has extensive experience in RSV challenge trials, having inoculated approximately 2,000 healthy volunteers across 30 such trials.
Market Context and Future Prospects
The market for RSV prophylactic products is projected to reach $16 billion by 2030, up from $582 million in 2020, underscoring the significant commercial potential for effective RSV treatments. Inhalon Biopharma's IN-002, with its innovative inhaled antibody delivery, is poised to address the unmet medical need and potentially capture a significant share of this growing market.
