Ness Therapeutics

Ness Therapeutics is a Canadian biotech developing N001, a self-administered intranasal prophylactic medical countermeasure for upper respiratory tract infection (URTI) viruses. N001 is designed to strengthen first-line antiviral defense in the upper airway to stop transmission at the point of entry and prevent progression to more severe disease. Built for rapid deployment, it supports outbreak control, seasonal risk periods, and national security readiness, with clear biodefense and biosecurity relevance against respiratory viral threats. Development is supported by non-dilutive Government of Canada funding to accelerate IND-enabling readiness.

N001 targets the earliest window of exposure and the primary site of transmission, aiming to reduce spread and progression through a virus-agnostic, host-directed approach that is built for rapid deployment when vaccines or antivirals are not enough.

Progress to date (selected, non-confidential):
• Established laboratory-scale production and purification workflows, with robust antiviral bioactivity confirmed in vitro and in relevant cellular systems
• IND-enabling development underway across drug substance generation, advanced analytical characterization and potency, formulation development, and nonclinical tox/PK planning
• First-in-human planning underway with a focus on safety, PK/PD, and respiratory biomarker readouts

At GIS, we are seeking EU partners for defined optimization work, GMP clinical manufacturing toward Phase I supply, and Phase I clinical and biomarker collaborations to accelerate first-in-human readiness. The program is being advanced under a defensible IP strategy (patents and know-how), with details shared under CDA.