OUR SCIENCE
How LuCI Works
LuCI Replicates the Metabolic Benefits of Bariatric Surgery
AltrixBio's LuCI™ (Luminal Coating of the Intestine) is the first oral therapy designed to recreate the metabolic effects of bariatric surgery without altering anatomy, introducing foreign implants, or requiring systemic absorption.
LuCI’s mechanism is clinically validated, backed by decades of clinical knowledge and experience demonstrating that the metabolic effect of bariatric surgery drives remission in type 2 diabetes.
The Mechanism of Action:
Limit Nutrient Contact in the Gut
Following bariatric surgery, patients often experience remission of type 2 diabetes within days, before any significant weight loss has occurred. The surgery physically isolates the stomach and duodenum from nutrient contact, triggering a cascade of hormonal changes and effects:
- 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
These metabolic changes from bariatric surgery result in up to 40% of people with type 2 diabetes (T2D) no longer needing their diabetes medications by the time of discharge. At one year, 70-80% no longer need diabetes medications; many are still in remission 10 years later, and those who are not still have better glycemic control with fewer medications used than prior to surgery.⁷ ⁸
While injectable incretins have been shown to be effective at glycemic control and weight loss, they have not shown the levels of remission, glycemic efficacy or weight loss associated with bariatric surgery. ¹⁰ ¹¹
LuCI orally replicates the metabolic benefits of bariatric surgery without the medical need for surgery and the associated costs and risks.
How LuCI™ Works:
- Administered orally as a capsule
- Forms a transient, local coating (approximately 4-6 hours) in the stomach and proximal intestine (both duodenum and jejunum)
- Physically isolates mucosa from nutrients, recreating bypass-like conditions
- Then safely dissolves, leaving no systemic exposure
No systemic absorption
No implants
No binding to tissue
No interference with gut morphology
Preclinical Data:
Metabolic Benefits of Bariatric Surgery with an Oral Therapy
Pre-clinical studies have examined whether an oral administration of LuCI can recapitulate the metabolic effects of bariatric surgery resulting in improved glycemic control and weight loss.
Acute Effects²:
- Increased incretin hormone(GLP-1 and GIP) levels
- Suppressed gut hormone (ghrelin and leptin) levels
- Reduced postprandial glucose (up to 50% reduction in iAUC after oral glucose tolerance test)
- No observed adverse changes in gut tissue after daily use
Chronic Effects³ (35-day pre-clinical model):
- Increased incretin hormone levels
- Suppressed gut hormone levels
- Lowered fasting glucose
- Lowered LDL cholesterol
- 20% reduction in weight gain
- Increased insulin sensitivity
- Excellent tolerability in daily oral dosing
These preclinical results suggest LuCI™ can be clinically meaningful, replicating the beneficial metabolic effects of bariatric surgery with no systemic absorption
Peer-reviewed studies published in Nature Materials and Metabolism
Safety Profile: Backed by 40+ Years of Clinical Use
LuCI™ is based on a well-known compound: sucralfate, repurposed with a composition of matter issued patent to create a targeted stomach and proximal gut barrier. Sucralfate has:
- A 40-year history of use for treating gastrointestinal (GI) ulcers
- Extensive familiarity among physicians
- Safe and well-tolerated
LuCI™ is designed to transiently coat healthy tissue without absorption or disruption to replicate the effects of bariatric surgery.
Clinical Development Timeline: First-in-Human Trial in Progress
AltrixBio is moving rapidly toward clinical development, with FDA feedback that supports an expedited 505(b)(2) regulatory path. We anticipate launching a Phase 1 clinical trial in 2026.
Phase 1 Clinical Trial Overview:
- Study design: SAD/MAD/28-day extension
- Population: Healthy volunteers and subjects with type 2 diabetes
- Primary objectives: Safety, tolerability
- Secondary objectives: Early efficacy signals in glucose, hormonal biomarkers, and weight.
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