US-based bio-pharmaceutical company NeuroGenetic has reported positive results from its Phase I clinical trials of NGP 555 to treat Alzheimer’s disease.
NGP 555 is a small molecule modulator of the gamma-secretase complex, which acts as a Gamma-secretase modulator (GSM) by modifying the production of Abeta42, the amyloid held responsible for triggering the disease, to a shorter non-toxic form of amyloid.
It is administered orally in the form of a capsule on a once-daily basis.
The first-in human Phase I clinical trials received an R01 grant from the National Institute of Aging (NIA) and were intended to determine safety, pharmacokinetics, and biomarker changes in the cerebrospinal fluid induced by the administration of NGP 555.
The Phase Ia trial tested NGP 555 in young, healthy subjects who received a single ascending dose of NGP 555 at 25mg-300mg.
Another Phase Ib trial was held for 14 days as a randomised, placebo-controlled, double-blind study, which evaluated multiple ascending doses of NGP 555 in healthy volunteers aged 40 to 65 who received doses at 100mg-400mg.
The NGP 555 demonstrated safety and tolerability across the Phase I studies and effects on Abetaallofoms in cerebrospinal fluid was analysed using Mesoscale ELISA technology in a subset of subjects.
Subjects have exhibited a 51% favourable change in Abeta37 / Abeta42 ratios after completing 14 days of treatment compared to baseline pre-drug levels for 400mg and 36% for 200mg against 2% for placebo.
Additionally, NGP 555 has established a pharmacokinetic relationship with CSF biomarker changes.