At Proclara, we are working towards a singular goal: improving the lives of patients and families affected by Alzheimer’s and other protein misfolding diseases like systemic amyloidosis. Like you, we understand the urgent need for new disease-modifying treatments for these devastating diseases.
As we work to advance our pipeline of novel therapies and meet the great unmet need for new treatments, we strive to put patients, caregivers, and their families at the center of our efforts. We are inspired by your strength and resilience and committed to delivering innovative therapies with the potential to create a real difference in your lives.
To learn about enrolling in our clinical trial, please click the button below:
Proclara is currently conducting a Phase 1b study of its lead product candidate, NPT088, for the treatment of Alzheimer’s disease. NPT088 is a fusion protein combining GAIM with the backbone of a human immunoglobulin and is delivered by intravenous administration. In animal studies, it acts on both protein aggregates implicated in Alzheimer's disease — amyloid-β (Aβ) and tau — meaning NPT088 may be better suited to treat the complex pathophysiology of the disease than other monotherapies currently in development.
Proclara has also initiated a clinical development program with its next generation product candidate, NPT189, to address the protein aggregates implicated in systemic amyloidoses. NPT189 is a fusion protein combining an optimized version of GAIM with the backbone of a human immunoglobulin, created in Proclara’s R&D laboratories through extensive structure-activity research studies. Importantly, NPT189 may allow broad targeting of the wide range of misfolded proteins found in systemic amyloidoses, which display varied protein sequences. The first trial is a Phase 1a study in healthy subjects.
CL002, a Phase 1b clinical trial to evaluate NPT088, is a multicenter, randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation safety and tolerability study of NPT088 or placebo in patients with probable Alzheimer’s disease. Enrolled patients will receive an intravenous infusion of NPT088 or placebo once a month for six months during this study.
The study’s primary objective is to assess the safety and tolerability of multiple doses of NPT088 in patients with mild-to-moderate Alzheimer’s disease. The study will also evaluate the pharmacokinetics, and exploratory pharmacodynamic characteristics of multiple doses of NPT088, as measured by amyloid-β and tau PET imaging. We have completed the enrollment of this trial.
To learn about this study, including clinical trial locations:
This study is a Phase 1a, randomized, double-blind, placebo-controlled, single dose, dose escalation study of NPT189 in healthy subjects. Six dose cohorts are planned, each with a maximum of 8 subjects per cohort. Subjects will receive NPT189 or a matching placebo by intravenous (IV) infusion. The study will evaluate the safety and tolerability of NPT189 and the pharmacokinetic profile of NPT189 after a single IV infusion.
For more information about amyloidosis, visit the following resources:
PETscan image: top - 63 yrs old patient with probable Alzheimer's Disease, bottom - 53 yrs old control subject without dementia.
Piramal Imaging 2017