Lumen Bioscience has received up to $7m in US government funding to advance its intranasal antiviral candidate LMN-1001 into Phase 1 clinical development.

Lumen Bioscience has received up to $7M in US government funding to support Phase 1 clinical development of LMN-1001, an investigational intranasal antiviral designed to stimulate the body’s innate immune response.

The award from the Department of War’s Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense will fund a first-in-human study evaluating single and multiple doses of LMN-1001 in healthy volunteers.

The Phase 1 programme will assess safety, tolerability, pharmacokinetics and pharmacodynamic activity, alongside local innate immune activation following intranasal administration. Lumen expects the trial to begin in early autumn, with top-line data from the single-dose cohort anticipated in the second quarter of 2027 and results from the multiple-dose cohort expected in the second half of 2027.

Study will assess host-directed antiviral approach

LMN-1001 is an intranasal dry powder formulation of interferon lambda designed to activate local innate antiviral defences in the respiratory tract while limiting systemic exposure.

Rather than targeting a specific virus, the programme is based on a host-directed approach, in which treatment aims to stimulate antiviral mechanisms within the patient. Lumen is developing LMN-1001 as a potential broad-spectrum countermeasure against respiratory viral threats, including emerging infectious diseases.

The Phase 1 study will begin with escalating single doses before moving to repeat-dose administration. The multiple-dose component is intended to help researchers assess dosing schedules and the duration of local pharmacodynamic activity alongside safety and tolerability.

The trial will also generate data on systemic exposure and immunogenicity, providing an initial assessment of how the intranasal treatment behaves in humans.

Brian Finrow, CEO of Lumen Bioscience, said: “Host-directed therapies represent an important new approach to biodefense because they have the potential to protect against known, emerging, and genetically modified viral threats without requiring prior knowledge of the specific pathogen.”

He added: “This award enables us to advance LMN-1001 into clinical testing and generate the human data needed to evaluate this novel approach.”

Funding builds on earlier countermeasure programme

The new funding follows earlier US government-supported work on LMN-1001, which has been investigated as a rapidly deployable antiviral countermeasure for prophylaxis and early treatment.

Lumen said the programme is intended to support development of a treatment that could potentially be deployed against respiratory viral threats without requiring a pathogen-specific antiviral to be identified and manufactured in advance.

The company is also using its spirulina-based biomanufacturing platform to produce recombinant protein therapeutics. It says the platform is designed to support large-scale production and stable, needle-free formulations.

LMN-1001 is being developed for potential use in populations including military personnel, first responders, healthcare workers and civilians at risk of exposure to respiratory viral pathogens.

The candidate remains investigational and has not been approved by the US Food and Drug Administration or any other regulatory authority.

The Phase 1 programme will therefore provide the first clinical data needed to assess whether the host-directed approach can generate the intended local antiviral response in humans and establish a dose and schedule for subsequent clinical development.