Platform Evidence
Platform Evidence & Applications
Molecule studies completed to date provide evidence of the breadth and applicability of the Mirai™ architecture. They should not be interpreted as independently developed product assets unless specifically stated.
How to read the evidence
Pre-Clinical Development
Budesonide and fluticasone propionate formulations have generated RLD-comparable in-vitro aerosol-performance signals through the Mirai™ development chassis during independent Intertek testing. Ciclesonide, a repurposed candidate for eosinophilic esophagitis (EoE), has separately completed independent proof-of-concept testing at Intertek (emitted dose and APSD by extended cascade impaction, across two batches). Formulation details and reports are available on request and on signing of a CDA.
| API (INN) | Therapeutic Area | Analytical | Status |
|---|---|---|---|
| BudesonideICS - Inhaled CorticosteroidIndependently tested | Asthma | DDU, APSD (NGI) | POC - Overlaid RLD |
| Fluticasone propionateICS - Inhaled CorticosteroidIndependently tested | Asthma | DDU, APSD (NGI) | POC - Matched RLD |
| CiclesonideICS - Inhaled CorticosteroidIndependently tested | EoE | DDU, APSD (CI) | POC - Repurposed drug |
POC = Proof of Concept · DDU = Dose Delivered Uniformity · APSD = Aerodynamic Particle Size Distribution (incl. MMAD, Mass Median Aerodynamic Diameter) · NGI = Next Generation Impactor · CI = Cascade Impactor · EoE = Eosinophilic Esophagitis · RLD = Reference Listed Drug
Reflects in-vitro device performance (pre-clinical); no human trials have been conducted.
Formulation Capability
Team formulation expertiseGiven the encouraging pre-clinical results - completely matching the APSD of the RLD for budesonide and performing very closely with fluticasone propionate at first attempt - Knightpoint has the expertise to develop a broad range of dry-powder formulations across the major respiratory classes - for example tiotropium bromide (COPD), albuterol (rescue), or zanamivir (antiviral).
Partnership Opportunity: Generic Triple-Combination Therapy
Potential future applicationKnightpoint is open to a partnership opportunity for any client seeking to develop the next generation of triple-therapy medicines currently on the market. Through in-house, in-depth technical expertise across the API / formulation / device eco-system, Knightpoint can develop - for example - umeclidinium / vilanterol / fluticasone furoate in a single-capsule system delivered through the Mirai™ platform.
Formulation Breadth
Representative Molecules and Platform Applications
The molecules below illustrate the breadth of formulation capability across every major respiratory class, from inhaled corticosteroids to antimicrobials. They are representative examples of what the Mirai™ platform can formulate - not a portfolio of active pharmaceutical ingredients owned or licensed by Knightpoint.
Inhaled Corticosteroids (ICS)
Anti-inflammatory agents for respiratory conditions
Long-Acting Muscarinic Antagonists (LAMA)
Bronchodilators for COPD and respiratory conditions
Long-Acting Beta-Agonists (LABA)
Bronchodilators for asthma and COPD
Antimicrobials
Inhaled antibiotics for respiratory infections
Formulation–Device Integration Capability
Knightpoint develops the formulation and the device together as one system. This integrated capability - not formulation offered in isolation - is what lets each combination product be optimised end-to-end on the Mirai™ platform.
DPI Formulations
Dry powder inhaler formulation development optimized for the Mirai™ platform.
Combination Products
Multi-component formulations including dual and triple-combination therapies.
Stability & Characterisation
Formulation stability and in-vitro aerosol characterisation, evaluated on the Mirai™ device.
FDA Combination Product Pathway
Products built on the Mirai™ device follow the FDA combination product regulatory pathway - integrated drug + device products evaluated as a single system. This approach enables:
- Optimized device-formulation integration
- Unified regulatory submission
- Clear primary mode of action designation
- Potential for expedited development timelines
Our Expertise
Strategic Opportunities
The Mirai™ patent estate, device architecture, development evidence and associated know-how are available for confidential strategic discussion. Selected licensing and programme structures may also be considered.