Pipeline & Licensing
Molecules, Evidence & Licensing
The Mirai™ device is a drug-agnostic delivery platform. Three formulations have completed pre-clinical proof of concept through the Mirai™ engine, and our API portfolio and formulation expertise span every major respiratory class - all available for licensing, co-development, or acquisition. All molecules are referenced by generic (INN) name.
Pre-Clinical Development
Proof of conceptThe following formulations have undergone pre-clinical development and testing through the Mirai™ engine. Formulation details and reports are available on request and on signing of a CDA.
| API (INN) | Therapeutic Area | Analytical | Status |
|---|---|---|---|
| BudesonideICS - Inhaled Corticosteroid | Asthma | DDU, APSD (NGI) | POC - Overlaid RLD |
| Fluticasone propionateICS - Inhaled Corticosteroid | Asthma | DDU, APSD (NGI) | POC - Matched RLD |
| CiclesonideICS - Inhaled Corticosteroid | 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
Given 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 is highly confident that, given our deep understanding of the formulation of any currently marketed asthma/COPD medicine and our knowledge of the airflow pathways through the device, we can develop any dry powder formulation a client may choose - for example tiotropium bromide (COPD), albuterol (rescue), or zanamivir (antiviral).
Partnership Opportunity: Generic Triple-Combination Therapy
Knightpoint 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.
API Portfolio
APIs Available for Licensing
A comprehensive portfolio of active pharmaceutical ingredients for respiratory combination products, with formulation expertise across every major therapeutic class. All APIs are available for licensing.
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 Services
Beyond API sourcing, Knightpoint Group provides comprehensive formulation development services for combination products.
DPI Formulations
Dry powder inhaler formulation development optimized for the Mirai™ platform.
Combination Products
Multi-component formulations including dual and triple-combination therapies.
Stability & Testing
Comprehensive stability programs and analytical method development.
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
Licensing & Partnership Opportunities
The Mirai™ platform, API portfolio, and formulation expertise are available for licensing, co-development, or acquisition. Our business development team is ready to discuss partnership structures.