Orexo has announced that its AmorphOX technology received positive data in a new preclinical pharmacokinetic in vivo study.
The AmorphOX technology was used to develop three powder-based intranasal formulations with semaglutide, which were compared with an oral and an injectable formulation.
Rybelsus, a semaglutide tablet, and Wegovy, an injectable semaglutide, were used as the comparisons.
Two of the AmorphOX powder formulations showed a sevenfold increase in plasma values compared with the oral tablet.
Although, as expected, they had lower values than the semaglutide injectable.
In addition to higher exposure than the oral route, the AmorphOX formulations exhibited lower variability in plasma concentration.
The data from this study further demonstrates the ability of the AmorphOX technology to develop formulations for large molecules that are well absorbed through mucosal membranes.
An AmorphOX-formulated intranasal semaglutide may provide needle-free delivery with improved convenience, potentially better adherence, and would not require refrigeration.
Dosing schedules, depending on intranasal dosage strength and therapeutic levels achieved, may also be extended to require less frequent dosing than the oral route.
Robert Rönn, SVP and Head of R&D, commented: "It's promising that our AmorphOX powder technology has successfully managed to formulate and stabilise large peptides like semaglutide."
"This could pave the way for effective intranasal delivery of semaglutide and other GLP-1 receptor agonists."
"The study results underpin our updated AmorphOX strategy to prioritise larger molecules like peptides, proteins, and vaccines."
"The results will support Orexo in establishing strategic partnerships that expand and accelerate the use of this novel delivery method for more efficient treatment options."