US-based biotechnology company Proclara Biosciences has begun its Phase Ib clinical trial of NPT088 to treat Alzheimer’s disease.
NPT088 is an intravenously administered fusion protein based on the company’s proprietary general amyloid interaction motif (GAIM).
GAIM is used to target the common amyloid protein conformation, disrupt and inhibit the formation of misfolded protein assemblies of Aβ, tau and α-synuclein, as well as prevent the transmission of toxic element through cells.
Previously conducted in vitro preclinical studies have demonstrated the efficacy of NPT088 to target and selectively fuse with Aβ and tau aggregates and subsequently lowering its level in a mouse model of Alzheimer’s disease.
The Phase Ib trial has been designed as a randomised, double-blind, placebo-controlled study intended to test the safety and tolerability of multiple doses of NPT088.
The trial also intends to determine the pharmacokinetics, immunogenicity and pharmacodynamic profile of NPT088 measured by Aβ and tau PET imaging.
Proclara chief scientific officer Richard Fisher said: “It is well-established that Alzheimer’s and other neurodegenerative diseases progress from the buildup of multiple misfolded proteins, a key reason why these diseases have proven so challenging to treat.
“The initiation of the NPT088 Phase Ib trial is supported by a substantial preclinical development programme and the recent successful completion of a Phase Ia study in healthy volunteers.
“We believe that our unique approach to targeting misfolded proteins holds great potential to transform the lives of patients suffering from devastating neurodegenerative diseases, who currently have no effective, disease-modifying treatment options.”
The completion of the trial is expected to support the company’s future Phase II/III development programmes for Alzheimer’s disease and Parkinson’s disease.