Proclara’s therapies are designed to simultaneously target multiple misfolded proteins implicated in neurodegenerative and other diseases.
Our lead product candidate, NPT088, is currently in clinical development for the treatment of Alzheimer’s disease. We are also advancing preclinical programs in a broad range of neurodegenerative and systemic amyloidosis diseases.
Proclara Bioscience’s lead development program, NPT088, is a fusion protein combining GAIM with the backbone of a human immunoglobulin, and is delivered by intravenous administration. Because it acts on both protein aggregates implicated in Alzheimer’s disease – amyloid-β (Aβ) and Tau – NPT088 may be better suited to treat the complex pathophysiology of the disease than other monotherapies currently in development.
Proclara recently completed a Phase 1a safety study of NPT088 involving 40 healthy volunteers, which demonstrated that a single administration appears to be both safe and well tolerated at multiple dose levels.
We are currently midway through conducting a Phase 1b, multiple ascending dose study of NPT088, which will enroll up to 66 patients diagnosed with probable Alzheimer’s disease. The randomized, double-blind, placebo-controlled study will evaluate the safety and tolerability of multiple doses of NPT088, as well as pharmacokinetics, immunogenicity and pharmacodynamic (effects on biomarkers) characteristics.
NPT189 is a 2nd generation GAIM-immunoglobulin fusion designed to lower the risk of human immunogenicity and displaying potent targeting of misfolded aggregated protein deposits found in systemic amyloidoses, such as transthyretin (TTR) and antibody light chain (AL) aggregates. NPT189 is currently proceeding through manufacturing development and being evaluated in preclinical animal safety studies in preparation for IND filing and clinical testing to commence in H1 2018.
3rd Generation Candidates
In addition to our two drug candidates NPT088 and NPT189, Proclara has conducted extensive Structure Activity Relationship (SAR) research to identify 3rd generation candidates using our GAIM technology platform with attributes that should deliver potential benefits to patients suffering from a broad range of neurodegenerative and systemic amyloidosis diseases.