The LuCI™ Platform
What is LuCI?
Surgery-like metabolic results.
Delivered in a pill.
LuCI™ (Luminal Coating of the Intestine) represents a fundamentally different approach, one that recreates the core metabolic effects of gastric bypass surgery by providing a local, non-systemic coating in the stomach and upper gastrointestinal (GI) tract (both duodenum and jejunum).
LuCI™ is more than a single drug candidate. It's a scalable, patent-protected oral platform with applications across type 2 diabetes, obesity, delivery, and beyond.
What Is LuCI™?
LuCI is a once-daily pill that forms a temporary barrier on the stomach and upper GI. This coating replicates the physical isolation that is created by bariatric surgery, triggering the same hormonal and glycemic responses without surgery or needles.
The result:
- Favorable gut endocrine response that impact feeding behavior (ghrelin, leptin, bile acids)
- Augmented incretin signal (GLP-1 and GIP)
- Improved insulin sensitivity and glycemic control
- Decreased caloric intake
Preclinical models confirm: LuCI elicits the same endocrine and metabolic responses seen in bariatric surgery with strong efficacy signals, excellent tolerability, and no systemic exposure.² ³
Platform Overview:
What Makes LuCI™ Different?
Local Action
LuCI works where it matters, in the gut lumen, without entering the bloodstream. It delivers therapeutic effects without systemic risk.
Dual-Site Targeting
LuCI™ uniquely provides a barrier to both the stomach and upper gastrointestinal tract(both duodenum and jejunum), which is essential to replicate the full metabolic effect of bariatric surgery.
Transient Effect
LuCI forms a temporary barrier that lasts approximately four hours. Electrostatic, not covalent bonding. No accumulation. No implants.
Safe, Familiar Foundation
Built on a proprietary modification of sucralfate, a well-characterized, well-tolerated molecule with over 40 years of safe clinical use.
Platform Potential:
Beyond Adult Type 2 Diabetes
AltrixBio will conduct the initial studies of LuCI in adults with type 2 diabetes. However, the metabolic effects of LuCI have the potential to provide broader therapeutic value. Additional applications for a safe, well-tolerated oral medication in the cardiometabolic space include:
- Long-term weight management for individuals who come off of Incretins (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
LuCI provides a foundation for the development of multiple therapeutic indications, combining anticipated regulatory efficiency with therapeutic flexibility.
Platform Potential:
Oral Peptide & Macro Molecule Delivery
The challenges associated with the oral delivery of peptides and macro molecules are numerous, including pH and gut enzyme mediated degradation, and low permeability and systemic absorption. AltrixBio has conducted preliminary work that demonstrates LuCI can overcome many of these delivery challenges, including:
In addition to a strong patent position, AltrixBio has received regulatory feedback from the U.S. FDA that supports:
- Demonstrates protection of peptides/proteins from the stomach environment
- Prolongs direct adherence of the drug to the stomach and intestinal mucosa walls, potentially enhancing absorption from the gut
- Data with model peptides supports potential to augment gut-systemic absorption.²
LuCI combines easily with powder forms of drug and can be combined with permeation enhancers to augment transport. Utilizing LuCI for drug delivery could also extend a products’ patent life.
Patent Protection & Regulatory Advantage
LuCI is protected by issued U.S. patents covering its composition and method of use, creating a robust, defendable 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 path
- A streamlined preclinical and CMC requirement set
- Initiation of phase 1 studies in people with type 2 diabetes
LuCI benefits from a de-risked regulatory strategy, one that capitalizes on existing safety data of sucralfate and provides rapid product and clinical development.
Summary
LuCI is:
- Scientifically validated to recapitulate the metabolic benefits of bariatric surgery
- 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, possibly replacing injections.
With issued patents, an expedited regulatory pathway and an experienced leadership team, AltrixBio is building a product and a platform with the potential to reshape metabolic treatment.
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