The AJN003 Platform
What is AJN003?
An Oral Therapy Designed to Shift Nutrient Sensing
AJN003 represents a fundamentally different approach to treating type 2 diabetes and obesity—a local, non-systemic coating in the stomach and upper gastrointestinal (GI) tract (duodenum and jejunum) that alters nutrient sensing to trigger hormonal and glycemic responses.
Inspired by the rapid diabetes resolution observed following bariatric surgery, where nutrient sensing shifts distally in the GI tract, AJN003 is a scalable, patent-protected oral platform with applications across type 2 diabetes, obesity, drug delivery, and beyond.
How AJN003 Works
AJN003 is a once-daily oral therapy that forms a temporary barrier on the stomach and upper GI. This protective coating alters nutrient sensing to trigger a metabolic reset with our surgery or injections.
The result:
- Favorable gut endocrine response that impacts feeding behavior (ghrelin, leptin, bile acids)
- Augmented incretin signal (GLP-1 and GIP)
- Improved insulin sensitivity and glycemic control
- Decreased caloric intake
Pre-clinical models confirm: AJN003 demonstrates strong metabolic and efficacy signals, excellent tolerability, and no systemic exposure.² ³
Platform Overview:
What Makes AJN003 Different?
Local Action
AJN003 works in the gut lumen without entering the bloodstream, delivering therapeutic effects without systemic risk.
Dual-Site Targeting
AJN003 uniquely provides a barrier to both the stomach and upper gastrointestinal tract (duodenum and jejunum), essential for inducing a comprehensive metabolic reset.
Transient Effect
AJN003 forms a temporary protective barrier through electrostatic (not covalent) bonding. No accumulation. No implants.
Established Foundation
Built on a proprietary modification of sucralfate, a well-characterized, well-tolerated molecule with 40+ years of clinical use.
Platform Potential: indications
Beyond Adult Type 2 Diabetes
While type 2 diabetes is the initial indication, AJN003's novel mechanism presents opportunities for broader therapeutic applications including:
- Long-term weight maintenance for individuals who discontinue incretin therapy (GLP-1/GIPs)
- Adult weight reduction and long-term weight management
- Pediatric weight reduction and long-term weight management
- Pediatric type 2 diabetes (non-invasive, age-appropriate therapy)
- Metabolic-associated steatohepatitis (MASH) through metabolic modulation
- Polycystic ovary syndrome (PCOS) through improved insulin sensitivity and glucose control
AJN003 provides a foundation for multiple therapeutic indications, combining regulatory efficiency with therapeutic flexibility.
Platform Potential: drug delivery
Enabling Oral Administration of Peptides and Macromolecules
The challenges of oral peptide delivery include pH and enzyme-mediated degradation, plus low permeability and absorption. Preliminary work demonstrates AJN003 can overcome many delivery challenges:
- Protection of peptides/proteins from the stomach environment
- Prolonged adherence to the stomach and intestinal mucosa, potentially enhancing absorption
- Data with model peptides supporting potential to augment gut-to-systemic absorption.²
AJN003 combines easily with powder drug forms and can be used with permeation enhancers to augment transport. Utilizing AJN003 for drug delivery could extend a product's patent life.
Patent Protection & Regulatory Advantage
AJN003 is protected by issued U.S. patents covering its composition and method of use, creating a robust, intellectual property (IP) position.
In addition to a strong patent position, AltrixBio has received regulatory feedback from the U.S. FDA that supports:
- A 505(b)(2) expedited pathway
- Stream-lined pre-clinical and CMC requirements
- Phase 1 studies conducted in people with type 2 diabetes
AJN003 benefits from a de-risked regulatory strategy that capitalizes on sucralfate's existing safety data, enabling rapid product and clinical development.
Summary
AJN003 is:
- Pre-clinicaly validated to trigger the strong metabolic response that could improve glycemic control and weight loss
- A well-tolerated oral therapy for combination use, step-down therapy, or standalone treatment in type 2 diabetes
- An oral agent that can play a significant role in the rapidly growing metabolic market
- A novel drug delivery platform with potential to enable oral administration of peptides and macromolecules.
With issued patents, an expedited regulatory pathway, and an experienced leadership team, AltrixBio is building a product and a platform with potential to reshape metabolic treatment.
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