Lyndra Therapeutics reported positive results from a pharmacokinetics study of its once-weekly drug-delivery capsule, touting that it successfully transitioned a once-daily therapy to a weekly dosage form.
The Watertown, Mass.-based company’s oral drug-delivery technique is designed to provide sustained release of one or more drugs for up to a week. Lyndra’s star-shaped capsule opens when it reaches the stomach and eventually leaves the body via the user’s gastrointestinal tract.
In an open-label, single dose PK study, eight healthy volunteers were treated with a prototype of the product containing memantine hydrochloride. The capsule’s PK profile and gastric-retentive properties were comparable to that of the commercially-available Namenda XR product.
All of the trial’s participants finished the study and tolerated the extended-release dosage form with transient, mild adverse events.
“As we set out to show with this study, preliminary data demonstrate predictable pharmacokinetics over seven days in healthy subjects,” co-founder & chief scientific officer Andrew Bellinger said in prepared remarks. “These positive results will accelerate our path toward commercialization, starting with our planned IND for schizophrenia in 2019 and targeting Phase II trials the following year.”
“Non-adherence to prescribed medications is a global epidemic, and this led us to start asking ‘what if we stopped trying to change people and changed the pill instead,'” CEO Amy Schulman added. “And that is exactly what we are working on—with these early positive results we can focus on making medicines that reduce the burden of the daily pill, starting with Alzheimer’s Disease and schizophrenia.”