Audax Medical

No approved antiviral exists for the common cold

Rhinovirus causes billions of infections each year, triggers serious complications in vulnerable patients, and has defeated every antiviral approach to date. Audax Medical is developing Nx3, a nasal spray designed to neutralize respiratory viruses at the point of entry, at the first signs of infection.

Preclinical stage · Patented platform · Lead program: rhinovirus
Audax Medical

A preclinical-stage antiviral platform targeting respiratory viruses at the point of entry.

Novel Mechanism

Designed to bind directly to viral particles through physicochemical interactions before they can enter host cells.

Rhinovirus Focus

Addressing a significant unmet need: no specific antiviral therapy is currently approved for rhinovirus infection.

Platform Breadth

Evaluated against multiple respiratory viruses in preclinical models, supporting potential breadth across multiple viruses.

The Problem

Billions of infections. No approved antiviral. No adequate solution.

160+ known rhinovirus serotypes, too many for strain-specific approaches
0 approved antiviral therapies for rhinovirus infection
#1 cause of the common cold, asthma exacerbations, and COPD flares
Zero approved treatments that target rhinovirus externally at the point of entry. This is the mechanism Nx3 is designed to deliver

Rhinovirus is the leading cause of the common cold and a significant trigger of asthma exacerbations, COPD flares, and secondary respiratory complications in vulnerable populations, including the elderly, immunocompromised, and young children. For patients with chronic respiratory conditions, a single rhinovirus infection can mean hospitalization, lost function, and prolonged recovery.

Despite causing billions of infections annually and substantial economic burden through healthcare visits and lost productivity, no specific antiviral therapy is currently approved. The existence of over 160 known serotypes has historically defeated conventional antiviral approaches, which typically target a single viral strain or a narrow molecular target susceptible to mutation.

“Rhinoviruses are the leading cause of the common cold and a major trigger of asthma attacks and pneumonia, especially in vulnerable populations. Currently, no specific therapies exist.”
— Dr. Mirella Salvatore, MD, FIDSA · Senior Clinical Advisor, Audax Medical
Nx3 investigational nasal spray concept

Product concept illustration. Nx3 is in preclinical development and has not been approved by the FDA.

The Concept

A nasal spray, used at the first signs of infection

At the first signs of a respiratory infection, the patient administers Nx3 as a nasal spray. The nanoparticles are designed to coat viral particles throughout the respiratory tract, from the nasal passage through the throat and into the lungs, before they can attach to and enter host cells.

Unlike conventional antivirals that act after the virus has entered cells and begun replicating, Nx3 is designed to work upstream by targeting the virus externally at the point of entry, before the mechanisms that drive both symptoms and resistance can take hold.

Delivery Nasal spray
Timing First signs of infection
Site of action Upper airway
Mechanism External viral binding

Site of action: the respiratory tract

Cross-section of the respiratory tract showing NX3 nasal spray delivering nanoparticles from the nasal cavity through the throat and into the lungs, where they bind to and coat virus particles before cell entry

Conceptual illustration of intended mechanism. Nx3 is in preclinical development and has not been approved by the FDA.

The Science

How Nx3 is designed to work at the molecular level

Nx3 is a patented, self-assembling nanomolecule in preclinical development. A nanomolecule is an extremely small particle—about 1,000 times smaller than the width of a human hair—that can interact with viruses at the molecular level. Self-assembling means these molecules naturally organize themselves into the most effective structure without external intervention. It is designed to bind to respiratory viruses through strong physicochemical interactions. By binding to viruses, Nx3 essentially acts like molecular ‘glue’ that prevents viruses from attaching to and infecting healthy cells in your respiratory system, with the goal of reducing viral entry into host cells.

Step 01 — Delivery

Upper Airway Application

Nx3 is formulated as a nasal spray designed to deliver nanoparticles throughout the respiratory tract, from the nasal passage to the lungs. The nanoscale particle size may also support aerosol delivery via inhaler, a format under evaluation for lower respiratory tract applications.

Step 02 — Binding

Viral Surface Attachment

Like placing a protective cap on a connector port, the nanoparticles are designed to attach specifically to virus surfaces through physicochemical interactions. The virus remains intact, but its docking surface gets blocked, so it cannot connect to your cells. Just like a capped connector cannot connect to your phone or computer. Molecular dynamics simulations predict binding affinity at levels exceeding host cell attachment.

Step 03 — Neutralization

Entry Prevention

Bound viral particles are designed to be prevented from entering host cells, reducing the ability of the virus to replicate.

Step 04 — Clearance

Viral Clearance

The mechanism by which bound particles are subsequently cleared from the body is under investigation.

Point-of-Entry Antiviral Neutralization

Nx3 represents an externally acting neutralization approach. Rather than targeting viral replication inside cells, where mutation-driven resistance is a known challenge, Nx3 is designed to act at the point of viral entry by binding directly to conserved surface features. This mechanism targets the virus before it reaches the intracellular machinery that drives resistance in conventional antivirals.

Intellectual Property

The Nx3 platform is covered by issued U.S. intellectual property with claims spanning compositions, methods, and applications across multiple respiratory viruses.

Preclinical Evidence

Activity observed across multiple respiratory viruses

The following results are from preclinical studies. Nx3 has been evaluated in laboratory models across several respiratory viruses, with a current focus on rhinovirus. All results are preliminary and may not predict outcomes in humans.

Lead Program · In Vitro · RV-A1 · BCiNS1 Human Airway Cells
Dose-dependent viral load reduction

In human bronchial epithelial cells, Nx3 was tested at four concentrations (0.01, 0.1, 1, and 10 µg/mL) against RV-A1 virus-only control. Three concentrations (0.1, 1, and 10 µg/mL) demonstrated consistent reductions in viral RNA, reaching statistical significance (p<0.01 or better) as measured by qPCR at 96 hours post-infection. See detailed data ↓

Lead Program · In Vitro · RV-A1 · BCiNS1 Human Airway Cells
83% viral load reduction

Nx3 was associated with up to 83% reduction in RV-A1 viral RNA at the highest tested concentration in human bronchial epithelial cells, measured by qPCR at 96 hours post-infection.

Platform Characterization · Preclinical · Computational Modeling
~7× predicted binding affinity

Molecular dynamics simulations predict Nx3 binds to viral particles with approximately seven times greater affinity than host cell attachment. Experimental confirmation (e.g., TEM imaging) is planned.

Platform Characterization · In Vivo · SARS-CoV-2 · Animal Model
Significant lung viral reduction

Significant reduction in SARS-CoV-2 lung virus levels was observed within four days in an in vivo animal study, supporting platform activity beyond rhinovirus.

All results are from preclinical laboratory and animal studies. These findings are preliminary and may not predict safety, efficacy, or clinical outcomes in humans. Nx3 is in preclinical development and has not been approved by the U.S. Food and Drug Administration.

Lead Program Data: RV-A1

The following visualization presents dose-response data from an in vitro study of Nx3 against RV-A1 in human airway epithelial cells. Percentage reductions are calculated from mean viral RNA copy numbers relative to virus-only control.

In vitro study showed up to 83% reduction in rhinovirus RNA at highest tested concentration

RV-A1 (0.1 MOI) · BCiNS1 human bronchial epithelial cells · Viral RNA copy number by qPCR · 96 hours post-infection · n=3 per group

Viral RNA copies
0
500K
1.0M
1.5M
control
~1.2M
~1.1M
↓ 33%
~804K
↓ 46%
~648K
↓ 83%
~204K
Virus only(no treatment)
0.01 µg/mL
0.1 µg/mLp < 0.01
1 µg/mLp < 0.0001
10 µg/mLp < 0.0001

Four concentrations were tested (0.01, 0.1, 1, and 10 µg/mL). The three higher concentrations (0.1, 1, and 10 µg/mL) demonstrated consistent reductions in viral RNA versus control, each reaching statistical significance.

Lead program evidence (Rhinovirus)

Reduction of RV-A1 viral load observed in human airway epithelial cells across four concentrations, measured by qPCR. Three concentrations demonstrated consistent, statistically significant reductions in viral RNA.

Platform characterization

Activity against SARS-CoV-2 in in vitro models. Molecular dynamics simulations predicting binding affinity exceeding host cell attachment. A mechanism designed to act at viral entry rather than intracellular replication.

Key questions under evaluation

Extended dose-response characterization across additional rhinovirus serotypes. Formulation and delivery optimization for respiratory tract application, including evaluation of aerosol inhaler delivery. Safety and tolerability assessment in preclinical animal models. Broader respiratory virus panel evaluation.

Differentiation

How Nx3 compares to existing approaches

Current approved antivirals act intracellularly against a single pathogen, effective within their narrow scope, but fundamentally limited by strain specificity and susceptibility to viral resistance. Large categories of respiratory viruses, including rhinovirus, remain without any approved antiviral treatment. Nx3 is designed as a different category of antiviral entirely.

Three categories of antiviral approach

Category 1

Virus-Specific Antivirals

Drugs targeting a single virus through intracellular mechanisms. Effective within their narrow scope, but limited by strain specificity and susceptibility to resistance mutations.

Approved influenza antivirals Approved COVID-19 antivirals

No approved virus-specific antiviral exists for rhinovirus.

Category 2

Broad-Spectrum Antivirals

Agents designed to act against multiple viruses across different families. Despite their potential, development has been limited by difficulty achieving efficacy without toxicity, and by historical underinvestment.

Existing direct-acting antivirals (limited spectrum) Nucleoside analogs (toxicity limitations)

No approved broad-spectrum antiviral is delivered as a nasal spray or acts at the point of viral entry.

Category 3

Platform-Based Broad-Spectrum

Innovative approaches designed for adaptability across viral threats, acting through mechanisms distinct from intracellular targeting. These platforms aim to address the limitations of both virus-specific and conventional broad-spectrum antivirals.

Nx3 (preclinical)

Nx3 is designed to bind viral particles externally, before cell entry, through physicochemical surface interactions, potentially addressing multiple respiratory viruses through a single nasal spray format.

Head-to-head comparison

Attribute OTC Symptom Relief Virus-Specific Antivirals
e.g. approved influenza, COVID-19 antivirals
Nx3 Platform
preclinical
Approach Manages symptoms Targets intracellular viral replication Designed to bind viral particles at the point of entry
Spectrum Not antiviral Single virus (influenza or SARS-CoV-2) Evaluated against multiple respiratory viruses in preclinical models
Delivery Oral, topical Oral, IV Nasal spray (respiratory tract delivery; inhaler format under evaluation)
Resistance profile N/A Susceptible to viral mutations at target site Targets viral surface features, not intracellular machinery
Rhinovirus coverage No No (no approved antiviral for rhinovirus) Current lead development program
Cold-chain logistics No Varies by product (room temperature to refrigerated) Designed for room-temperature storage and distribution

The COVID-19 pandemic demonstrated both the clinical value and the inherent constraints of virus-specific antivirals. Existing approved treatments addressed a single pathogen through an intracellular mechanism vulnerable to resistance mutations. No equivalent treatment exists for rhinovirus, the most common respiratory virus, despite billions of annual infections and significant clinical burden in vulnerable populations.

Nx3 is designed to occupy a fundamentally different position: an externally acting, broad-spectrum nasal spray that targets viruses at the point of entry, with a production process designed for scalability without cold-chain logistics. If this mechanism translates from preclinical results to clinical outcomes, it would represent the first antiviral approach capable of addressing rhinovirus and potentially multiple respiratory viruses, through a single delivery format.

Nx3 is in preclinical development and has not been approved by the U.S. Food and Drug Administration. Comparisons to approved therapies are provided for context only and do not imply equivalent clinical evidence or regulatory status. Certain statements above are forward-looking and involve risks and uncertainties.
Leadership

Management and Scientific Advisory Team

Audax Medical brings together experienced leadership in biotech entrepreneurship, nanomaterials science, infectious disease medicine, pharmaceutical commercialization, and regulatory strategy.

MJ

Mark Johanson

Founder, President & Chief Executive Officer

Entrepreneur and inventor with over 30 years of leadership in medical devices and biotechnology. Founded and led Scandius BioMedical as President & CEO through venture funding, product commercialization, and exit to Covidien. Holds 28 issued patents across medical devices, regenerative medicine, and therapeutic technologies.

TW

Thomas Webster, Ph.D.

Chief Scientific Advisor

Materials scientist and biomedical engineer with 1,350+ publications, 74,000+ citations (H-index 137), and fellow of 8 academic societies. He has founded multiple startup companies. Former President, U.S. Society for Biomaterials. Professor at Brown University, with additional appointments at the University of the Basque Country, Saveetha University, and UFPI Brazil.

MS

Dr. Mirella Salvatore, MD, FIDSA

Senior Clinical Research Advisor

Infectious disease physician-scientist with 20+ years in antivirals and clinical trial strategy. Former Associate Professor at Weill Cornell. Published 60+ peer-reviewed studies. Board certified in Infectious Diseases.

PC

Philip J. Cross, MS

Senior Regulatory Advisor

Regulatory specialist in vaccines and gene and cell therapies with deep expertise in chemistry, manufacturing, and controls. Supported over 100 INDs and master files and released hundreds of clinical lots. Formerly with Wyeth, Centocor, University of Pennsylvania Gene Therapy Program, and Harvard Medical School’s Gene Therapy Initiative.

Strategic Opportunities

Partnering pathways

Audax Medical is seeking partners with capabilities in respiratory drug development, clinical operations, or established regulatory pathways in major markets. We are open to creative deal structures aligned with advancing Nx3 toward and through clinical development.

Research Collaboration

Joint evaluation of Nx3 activity against additional respiratory pathogens, combination approaches with existing antiviral or anti-inflammatory therapies, or expanded preclinical characterization in specialized models.

Co-Development

Partnerships to advance IND-enabling studies, formulation and manufacturing scale-up, and clinical program design. Particularly relevant for organizations with nasal drug delivery expertise or respiratory clinical trial infrastructure.

Licensing

Regional, indication-specific, or field-of-use licensing arrangements covering the Nx3 intellectual property portfolio. Audax is open to discussions across geographies and therapeutic contexts where the platform mechanism may apply.

Contact

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Nx3 is in preclinical development and has not been approved by the U.S. Food and Drug Administration.

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