Laxxon Medical has announced positive results from a pilot pharmacokinetic (PK) study of its oral GLP-1 agonist, LXM.2, a potential game-changer in diabetes, metabolic syndrome, and weight loss treatment. The study demonstrated a 10-fold increase in bioavailability compared to published results for competing products, marking a significant advancement in oral drug delivery for GLP-1 agonists.
The pilot nonclinical PK study confirmed the effectiveness of LXM.2's design, which includes an enteric coating and a permeation enhancer to boost drug absorption in the small intestine. These features are designed to overcome the challenges of delivering GLP-1 agonists orally, which have traditionally required injections.
SPID®-Technology
Laxxon's proprietary SPID®-Technology, licensed from Exentis, plays a crucial role in the development of LXM.2. This advanced manufacturing platform enables the creation of microtablets as small as 750 μm in diameter, facilitating multi-compartment designs, faster API release, and permeation enhancer integration. This technology allows for lower doses while maintaining high tolerability.
Klaus Kühne, Chief Operations Officer of Laxxon, emphasized the significance of the pilot PK study, stating that it provided "proof-of-concept for LXM.2, which is well designed to be a best-in-class product." He added that the innovation, made possible by 3D screen printing technology, holds significant promise for improving patient compliance, particularly for those who find daily injections a barrier to effective treatment.
Advantages of LXM.2 Microtablets
Laxxon's microtablets offer several advantages over traditional dosage forms:
- Enhanced Bioavailability: Overcomes challenges of poorly soluble APIs by increasing surface area and absorption.
- Controlled Release Profiles: Multi-compartment designs allow tailored therapeutic effects and minimized side effects.
- Flexible Administration Options: Sprinkle formulations improve dosing convenience and compliance, particularly for children, the elderly, and patients with swallowing difficulties.
Helmut Kerschbaumer, CEO of Laxxon Medical, stated, "The ability to combine advanced drug delivery with patient-friendly administration is central to Laxxon's mission. These initial results reaffirm our commitment to transforming medicine through innovation and making a tangible impact on patients' lives."
Future Development
Subsequent studies will focus on ascertaining the potential of an LXM.2 microtablet format, which is the next planned developmental step, in addition to further increased bioavailability and reduced gastrointestinal side effects. Laxxon Medical is also exploring the use of SPID®-Technology to develop advanced versions of new and existing pharmaceutical drugs, leveraging the FDA's 505(b)(2) regulatory pathway in the US and Hybrid applications under article 10(3) of Directive 2001/83/EC in the EU to fast-track product routes to market.
