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LXM.2 A 3D printed oral GLP-1 Agonist for weight loss

LXM.2 is Laxxon Medical’s oral GLP-1 Agonist treatment for weight loss, offering patients a non-invasive, once-a-day treatment made possible through our innovative 3D screen printing platform technology, SPID®.

Laxxon has developed an enteric coated oral tablet of a GLP-1 agonist combined with a permeation enhancer to increase bioavailability using its proprietary 3D printing manufacturing process. 

SPID® (Screen Printed Innovation Drug) Technology is Laxxon Medical’s disruptive 3D screen printing (3DSP) additive manufacturing process and technology platform. 

SPID® enables the development and production of smart drug delivery system (DDS) oral dosage forms with tailored pharmacokinetics based on complex formulations and geometric structures which optimize the release profiles of common pharmaceuticals and new chemical entities. 

SPID® - enabling the manufacturing of traditionally fragile molecules 

The sophisticated layer-by-layer production of SPID® enables a new generation of smart DDS’s through the heterogenous distribution of active pharmaceutical ingredients (APIs) and excipients.

The permeation enhancer in LXM.2 has traditionally been difficult to manufacture into an enteric coated oral solid via conventional methods such as direct compression or granulation. The enteric coating on LXM.2 is necessary to protect the GLP-1 from degrading prior to entering the small intestine - where the permeation enhancer boosts the amount of drug absorbed through the intestinal wall. 

Using SPID®, Laxxon has been able to precisely manufacture the final product in a way that stabilizes the permeation enhancer allowing for the enteric coating to be applied. 

SPID® - a patent-protected manufacturing process

Laxxon owns the exclusive worldwide rights for the development, production, and commercialization of this innovative 3DP SPID® technology. SPID® is a special additive manufacturing process based on the classic flatbed screen printing process widely used in electronic, automotive, and aerospace industries.

The company has 180+ patents and patent applications (both in-licensed and owned) worldwide with 4,000+ patent claims protecting its SPID® technology. All products produced by this 3DSP are patent protected.

The production capacity of traditional 3DP technologies is limited and typically used for R&D-sized batches. SPID® is capable of scaling from R&D batches to mass production for commercialization (> 1 million tablets per day per unit) with no change in the manufacturing process.

Laxxon is currently installing cGMP manufacturing units with its CDMO partner in Europe followed by the U.S.

LXM.2 – Designed with the patient in mind

GLP-1 agonists approved for weight loss are currently only available in injectable formulations. Patients must either inject themselves daily or weekly. These products also must be stored at specific conditions and have limited shelf lives.

LXM.2 is designed to provide patients with a once-daily oral medication to replace the daily or weekly injections.

Weight Loss Drug Market Forecast

The global market for anti-obesity medication could reach $100 billion by 2030, according to Goldman Sachs. With further innovation, new market entrants, and patent expiration, the price of weight loss drugs is likely to fall, potentially opening up new markets.

LXM.2 – An oral GLP-1 made possible by SPID®

Large molecules like GLP-1’s are difficult to formulate for oral drug delivery due to their:

Poor solubility – many peptides are poorly soluble in water which can decrease the amount of drug that enters the bloodstream through the intestinal wall

Size and complexity – their large size makes them poorly absorbable and susceptible to degradation by digestive enzymes 

Both leading to poor bioavailability.

Laxxon has carefully chosen a combination of ingredients to combat the low bioavailability of oral GLP-1s. The enteric coating protects the molecules from degradation in the stomach so that the active ingredient can pass into the small intestine. The permeation enhancer then will act to increase the amount of GLP-1 absorbed into the bloodstream. 

Each ingredient plays a crucial role in increasing the bioavailability of the GLP-1. The combination of these ingredients into an oral solid formulation is only possible due to Laxxon’s SPID®.

LXM.2 Drug Development Plan - Accelerated development program via the 505(b)2 pathway 

LXM.2 contains an FDA-approved GLP-1 that is nearing patent expiration. Laxxon will utilize the 505(b)2 pathway to accelerate its development program. Download the full fact sheet here.

 
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Laxxon Medical is dedicated to engineering patented 3D pharmaceutical solutions that optimize products and benefit patients. Our goal is to establish SPID®-Technology as a manufacturing process with the individual and the pharmaceutical partner in mind.




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