Laxxon Medical Announces Development Program for Non-Invasive, 3D Printed Oral GLP-1 Asset, Offering an Alternative to GLP-1 Injections on Market

• Using their SPID®-Technology, Laxxon Medical has manufactured a 3D printed oral tablet combining a GLP-1 receptor agonist and a permeation enhancer intended to increase bioavailability
• LXM.2 is being developed using the 505(b)2 pathway with an expected NDA submission in early 2027
• Laxxon is seeking to partner or out-license LXM.2

Laxxon Medical announced today the development program for LXM.2, a 3D printed oral glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of adults and pediatric patients 12 years and older with obesity.

LXM.2 is an enterically coated oral solid tablet consisting of a GLP-1 receptor agonist combined with a permeation enhancer intended to increase bioavailability. The addition of the permeation enhancer was made possible using Laxxon Medical’s SPID® (Screen Printed Innovative Drug) platform technology. 

“Polypeptides and proteins like GLP-1s are known to have low bioavailability due to the degradation in the GI tract and poor uptake, meaning they need protection from degradation and their absorption benefits from permeation enhancers. Traditionally, it has been difficult to manufacture products containing the permeation enhancer via conventional methods, such as direct compression or granulation, given its physicochemical properties. It has additionally been challenging for these traditional manufacturing methods to apply an enteric coating to the finished product.” said Dr. Achim Schneeberger, Laxxon Medical’s Chief Scientific Officer. “SPID®-Technology is not only characterized by precise and tailored dosing – its unique formulation allows manufacturing of oral solids containing clinically relevant doses of permeation enhancers at convincing hardness and low friability.”

The active pharmaceutical ingredient (API) in LXM.2 has already been approved by the FDA for use in adults and pediatric patients 12 years and older with obesity. LXM.2 is eligible to be developed using the 505(b)2 pathway. Laxxon has designed a streamlined development program and is targeting an NDA submission in early 2027.

Laxxon Medical CEO Helmut Kerschbaumer said: “LXM.2 would be a game-changer for patients struggling with obesity. Injectable medications, while effective, can be inconvenient and pose a barrier for some people. An oral option would offer greater ease of use and potentially improve adherence to treatment. This could significantly increase the number of patients who can successfully manage their weight and achieve long-term health benefits. The ability to use the 505(b)2 pathway means we can potentially get LXM.2 to patients quickly.”

Laxxon is seeking to partner or out-license LXM.2. A team of Laxxon Medical representatives will be attending BIO in San Diego, June 3-8, 2024.

Read more about LXM.2 here.