A Novel Oral Therapy
Designed to Shift Nutrient Sensing
AltrixBio’s AJN003 is pioneering a new approach and mechanism for diabetes treatment and related metabolic diseases.
A Fundamentally Different Approach to Type 2 Diabetes
Bariatric surgery and incretin hormone based therapies have demonstrated the critical importance of the GI tract in metabolic regulation. Bariatric surgery, in particular, achieves what no other therapy can - up to 40% of patients leave the hospital medication-free, and over 70% remain in diabetes remission at one year. This happens within days, before significant weight loss, driven by shifting nutrient sensing from the upper to lower GI tract and its associated metabolic reset. AltrixBio developed AJN003, inspired by this observation, as a simple, daily, non-systemic oral medication.
AJN003 represents a fundamentally different approach to T2D and metabolic conditions: it provides a local, transient, and protective coating of both the stomach and proximal intestine replicating the distal nutrient shift observed with bariatric surgery. This dual-site approach triggers a multi-hormonal metabolic reset. Studies have shown that this leads to improved insulin resistance, suppression of hunger-stimulating hormones, and increased incretin hormones, which in turn leads to improved glycemic control and weight loss.² ³
AltrixBio designed AJN003 as a category-defining, patent-protected therapy with the potential to transform treatment of T2D and obesity. AJN003 will complement and enhance currently available diabetes medications.
Incretins (GLPs/GIPs) are Helping Millions, but Additional Therapies are Needed
By providing both glycemic control and significant weight loss, injectable incretin treatments (GLP-1s and GLPs/GIPs) are helping millions of individuals achieve their glycemia and weight loss targets.
Because of their potent effects, these medications are demonstrating benefits in other cardiometabolic diseases including cardiovascular risk reduction, metabolic-associated steatohepatitis (MASH), sleep apnea and osteoarthritis.
Despite these benefits, over 50% of individuals taking incretins discontinue treatment within a year due to issues that include⁴:
- Side effects such as nausea and vomiting
- Injection fatigue and/or a preference for oral medication
- Sub-optimal glycemic and/or weight effects
- Difficulty accessing therapy.
There is a need for a simple, well-tolerated oral therapy that provides glycemic control and weight loss.
AJN003 is expected to be a well-tolerated once-daily oral therapy. It provides coating and protection to both the stomach and upper gastrointestinal tract (duodenum and jejunum), creating a transient barrier without surgery, implants, or the concern of systemic absorption.
Bio-engineered from sucralfate, a molecule that has been prescribed for more than 40 years with a well-known safety profile, AJN003 offers a novel approach to treating type 2 diabetes and obesity.
The Need is Urgent
Obesity and type 2 diabetes (T2D) are growing global health crises. And they’re accelerating.
- In the US, obesity rates rose from 28% to over 34% in just 12 years
- Diabetes now affects nearly 40 million American adults – over 15% of the population
- Globally, obesity has more than doubled since 1990
- T2D prevalence has jumped from 7% to 14% worldwide
The consequences are severe and growing:
- T2D is the leading cause of blindness, amputation, and kidney failure
- Every 7 seconds, someone dies from diabetes complications
- Having T2D nearly doubles the risk of heart attack
Despite the scale of the problem, current treatments aren’t enough.
There’s a clear need for safer, more scalable solutions that work at the root.
A Founding Mission Rooted in Personal Experience
AltrixBio represents more than another biotech venture. Our team is solving a problem we’ve lived.
Ali Tavakkoli, MD, saw diabetes destroy his family. As a bariatric surgeon, he has witnessed the dramatic metabolic reset that occurs following gastric bypass surgery - many of his patients with diabetes leave the hospital longer requiring diabetes their diabetes medications. This clinical observation inspired the development of AJN003.
Nancy Briefs, executive chair of the board and founder, lost both parents to diabetes. She's spent her career building and commercializing high-impact medical companies and has raised a total of $500M+ to do it. She is passionate about bringing a diabetes treatment that is effective, safe, weight friendly, and accessible to benefit individuals around the world.
Jeff Karp, PhD, a prolific inventor and engineer and a proponent of “Radical Simplicity”, set out to create an oral therapy that alters nutrient sensing to trigger metabolic changes. With his extensive experience in tissue engineering, Dr. Karp bio-engineered a safe and well-tolerated compound that has over 40 years of clinical history.
Beyond Type 2 Diabetes: Platform Potential
While type 2 diabetes is the initial indication for AJN003, its novel mechanism of action presents opportunities for broader therapeutic applications, including:
- Weight reduction and long-term weight management, pediatric type 2 diabetes, and cardiometabolic indications such as metabolic-associated steatohepatitis (MASH) and polycystic ovary syndrome (PCOS)
- Oral delivery of peptides and macro-molecules, opening the door to numerous stand alone and combination product forms.
Building Blocks of a De-Risked, Differentiated, Platform-Ready Therapy
Validated mechanism of action
AJN003 shifts nutrient sensing distally from the stomach and proximal intestine, triggering hormonal and metabolic responses that improve glycemic control and support weight loss.
Strong pre-clinical data
Pre-clinical models show AJN003 lowered fasting glucose, attenuated weight gain, and improved insulin sensitivity without systemic absorption.
Scalable
AJN003 is bio-engineered from a well-characterized molecule with 40+ years of clinical use. No systemic exposure. No complex biologics. No cold chain. Manufacturing is lean and scalable at commercial volumes.
Issued patents & expedited FDA path
AJN003 is protected by composition and method-of-use patents. Pre-IND feedback confirms the 505(b)(2) pathway and support for starting trials in people with T2DM.
AJN003 Positioned to Transform Standard of Care
A once daily oral with a novel mechanism of action that can be combined with or used as an alternative to other diabetes medications.
The Next Wave of Metabolic Therapeutics is Here
AJN003 designed to trigger comprehensive metabolic changes through the convenience of daily oral dosing, minimizing the barriers and clinical complexity that limit current therapies.
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