Proclara’s therapies are designed to simultaneously target multiple misfolded proteins implicated in both neurodegenerative disease and diseases involving systemic protein misfolding pathologies.
Our lead product candidate, NPT088, is currently in clinical development for the treatment of Alzheimer’s disease. We are evaluating our next-generation candidate NPT189 in a Phase 1a trial, and we plan to explore it in further studies as a treatment for patients with systemic amyloidoses, a group of rare disorders classified as orphan indications. We are also advancing preclinical programs in a broad range of neurodegenerative and systemic diseases.
Proclara Biosciences’ lead development program, NPT088, is a fusion protein combining GAIM with the backbone of a human immunoglobulin which is delivered by intravenous administration. Because preclinical evidence shows effects 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 with narrower pharmacologic targets that are currently in development.
Proclara 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 have also completed enrollment of our Phase 1b, multiple ascending dose study of NPT088 study in 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 and pharmacodynamic (effects on biomarkers) characteristics. We are expecting data in 2019.
NPT189 is a 2nd generation GAIM-immunoglobulin fusion designed to display potent targeting of misfolded aggregated protein deposits found in systemic amyloidoses, such as transthyretin (TTR) and antibody light chain (AL) aggregates. NPT189 is currently being assessed in an initial Phase 1a study, with further studies in patients with systemic amyloidosis planned.
3rd Generation Candidates
In addition to our two drug candidates NPT088 and NPT189, Proclara has conducted extensive Structure Activity Relationship (SAR) research to identify optimized 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.