The Science Behind AJN003
A Novel Mechanism: Altering Nutrient Sensing to Trigger Metabolic Reset
AltrixBio's AJN003 is the first oral therapy designed to trigger a metabolic reset by altering nutrient sensing in the upper GI tract - without surgery, implants or systemic absorption.
This approach was inspired by a well-documented clinical observation: following gastric bypass surgery, patients often experience remission of type 2 diabetes within days, before significant weight loss occurs.⁷ Research suggests this rapid metabolic improvement is associated with altered nutrient sensing in the upper GI tract, triggering changes in gut hormones and metabolic signaling.
Understanding the Metabolic Reset
Bariatric surgery physically reroutes the digestive tract causing nutrient sensing to shift from the upper to lower GI tract. This distal shift triggers a cascade of hormonal and metabolic changes:
- 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
Following gastric by surgery clinical studies show that up to 40% of people with type 2 diabetes (T2D) no longer need diabetes medications by hospital discharge. At one year, 70-80% remain medication-free; many sustain remission for 10+ years.⁷ ⁸
While injectable incretins demonstrate effectiveness for glycemic control and weight loss, they have not achieved the levels of diabetes remission or glycemic efficacy observed with bariatric surgery. ¹⁰ ¹¹
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The AJN003 Mechanism of Action
- Administered orally as a capsule
- Forms a transient, local and protective coating (approximately 4-6 hours) in the stomach and proximal intestine (both duodenum and jejunum)
- Shifts nutrient sensing distally to lower GI, triggering the hormonal and metabolic reset
- Safely dissolves, leaving no systemic exposure
No systemic absorption
No implants
No binding to tissue
No interference with gut morphology
Pre-clinical Evidence:
Demonstrating Metabolic Reset
Pre-clinical studies have examined whether an oral administration of AJN003 could replicate the metabolic effects observed when nutrient sensing shifts distally, resulting in improved glycemic control and weight loss.
Acute Effects (single dose)²:
- Increased incretin hormone (GLP-1 and GIP) levels
- Suppressed appetite-stimulating gut hormones (ghrelin and leptin)
- Reduced postprandial glucose (up to 50% reduction in AUC after oral glucose tolerance test)
- No observed adverse changes in gut tissue
Chronic Effects³ (35-day study):
- Increased incretin hormone levels
- Suppressed appetite-stimulating gut hormones
- Reduced fasting glucose
- Reduced LDL cholesterol
- 20% attenuation in weight gain
- Increased insulin sensitivity
- Excellent tolerability with no reported adverse side effects
These pre-clinical results suggest AJN003 can replicate beneficial metabolic effects with no systemic absorption
Peer-reviewed studies published in Nature Materials² and Metabolism³
Built on Proven Foundation
AJN003 bio-engineered from sucralfate, a well-characterized compound with a 40+ year safety record. Sucralfate has:
- Four decades of clinical use for treating gastrointestinal ulcers
- Extensive familiarity among physicians
- A record of safety and tolerability profile
AJN003 is bio-engineered from sucralfate with a proprietary modification protected by issued composition of matter patents. AJN003 creates a targeted barrier in the stomach and proximal intestine that transiently alters nutrient sensing without tissue absorption or structural disruption.
Clinical Development Timeline
AltrixBio is advancing toward clinical development with FDA feedback supporting an expedited 505(b)(2) regulatory pathway. We anticipate initiating a Phase 1 clinical trial in 2026.
Phase 1 Clinical Trial Overview:
- Study design: SAD/MAD plus an extension
- Population: Healthy volunteers and subjects with type 2 diabetes
- Primary objectives: Safety, tolerability
- Secondary objectives: Glycemic efficacy signals, metabolic biomarkers, and weight.
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