hVIVO, Inhalon Biopharma sign RSV human challenge trial contract

hVIVO has signed a contract with Inhalon Biopharma to assess its inhaled IN-002 antiviral candidate (“IN-002”) using the hVIVO Respiratory Syncytial Virus (RSV) Human Challenge Model.

The Phase 2a randomised, double-blinded placebo-controlled human challenge trial will evaluate the safety, pharmacokinetics and antiviral activity of inhaled IN-002 following RSV infection, at three dose levels, hVIVO said Monday in a press release.

Furthermore, hVIVO will leverage its in-house volunteer recruitment arm, FluCamp, to enrol healthy volunteers into the study. The study is expected to commence in H2 2026 at hVIVO’s state-of-the-art quarantine facilities in Canary Wharf, with the majority of revenue expected to be recognised in 2026, hVIVO said.

Yamin ‘Mo’ Khan, Chief Executive Officer of hVIVO, said: “We previously identified the next generation of vaccines and antivirals, including mucosal-based delivery systems, as being a key growth driver for our challenge trial business. The contract win strengthens our longer term orderbook, adding to visibility into 2026. Inhalon’s IN-002 and its innovative delivery platform could provide a novel way to combat RSV infections. The study is also notable for including three dosing arms – further supporting the trend of biopharma companies looking to obtain greater actionable insights into their candidates earlier to help inform later-stage field trials.”

 John Whelan, President and Chief Executive Officer of Inhalon, said: “We look forward to working with hVIVO on this Phase 2a study of our inhaled IN-002 antiviral candidate for RSV. Because preventive vaccines are underutilized, RSV and other respiratory infections continue to pose a significant risk to public health. There remains an unmet need for novel therapeutics that can treat underlying respiratory diseases counteracting severe illness, particularly in vulnerable populations such as infants, toddlers, and the elderly. Inhalon’s inhaled antibody treatment approach not only targets the underlying pathophysiology of RSV and other respiratory infections, it also provides painless, self-administration by patients in their own homes, potentially reducing hospitalizations.”