A Phase 1 clinical trial in healthy volunteers for investigational therapy AZP2006 — an oral medicine that is meant to clear accumulations of toxic proteins in Alzheimer’s disease and progressive supranuclear palsy — has shown positive results, says the therapy’s developer, AlzProtect.
Progressive supranuclear palsy (PSP) is a rare, progressive disease that arises due to loss of brain cells as a result of accumulations of abnormal tau protein aggregates.
The study, launched in 2018, investigated the effect of food intake on the pharmacokinetic profile of AZP2006 following a single oral administration of the therapy in 14 healthy volunteers.
Pharmacokinetics, sometimes described as what the body does to a drug, refers to the movement of drug into, through, and out of the body, including the time course of its absorption, bioavailability, distribution, metabolism, and excretion.
“This food effects study will explore the optimal timing of AZP2006 versus food intake. On the other hand, the results will make it possible to follow up on the next phase 2 clinical study in patients, planned for 2019 ” Philippe Verwaerde, president and scientific director of Alzprotect said in a 2018 press release.
The results showed that AZP2006 was well-tolerated by all volunteers, with food intake affecting the therapy moderately.
A previous Phase 1 trial with 88 healthy volunteers showed that after oral administration of AZP2006, the therapy was well-absorbed by the intestine and well-tolerated.
“AlzProtect, with this new success, has now all the elements necessary to apply for our next phase 2a study with PSP patients. The first patient recruitments will occur in 2019,” Verwaerde, president and scientific director of AlzProtect, said in a recent press release.
AZP2006 is a small molecule designed to restore the cleaning process of the neurons, thereby halting the accumulation of toxic proteins in Alzheimer’s, like beta-amyloid and tau protein. The therapy aims to slow the disease progression of Alzheimer’s and PSP.
AZP2006 has been granted orphan drug designation for the treatment of PSP by the U.S. Food and Drug Administration and the European Medicines Agency.
This designation provides several benefits, including tax incentives, exemption from user fees and potential market exclusivity for several years following approval.
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