Proclara Biosciences Announces Initiation of Phase 1b Clinical Trial of NPT088 for Alzheimer’s Disease

CAMBRIDGE, MA, USA I September 7 2016 I Proclara Biosciences, a biotechnology company developing novel therapies for diseases caused by protein misfolding, today announced that it has initiated a Phase 1b clinical trial evaluating NPT088, its lead development candidate for Alzheimer’s disease. In a separate announcement also released today, the former NeuroPhage Pharmaceuticals reported that it has secured $47 million in new financing and relaunched under the name Proclara Biosciences as a clinical-stage company.

“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,” said Richard Fisher, Ph.D., chief scientific officer of Proclara. “The initiation of the NPT088 Phase 1b trial is supported by a substantial preclinical development program and the recent successful completion of a Phase 1a 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.”

Clinical overview

Proclara’s approach is based on established knowledge that several toxic misfolded protein aggregates, including Aβ, tau and α-synuclein, share a common amyloid fold and the proprietary discovery of a protein motif that recognizes this common feature. This proprietary motif is called General Amyloid Interaction Motif (GAIM). Proclara has developed a pipeline of drug candidates that use GAIM to target the common amyloid protein conformation, dissociating and preventing the formation of misfolded protein assemblies, and blocking the cell-to-cell transmission of toxic aggregates. The company’s lead development candidate, NPT088, is a GAIM-Ig fusion protein, initially in development for the treatment of Alzheimer’s disease.

In in vitro preclinical studies, NPT088 showed potent and selective binding to Aβ and tau aggregates. In subsequent in vivo studies, NPT088 effectively reduced the levels of Aβ plaque and tau aggregate in a mouse model of Alzheimer’s disease, resulting in improvements in functional endpoints, including cognition. In further studies, for which Proclara received support from the Michael J. Fox Foundation, NPT088 reduced levels of alpha-synuclein aggregates in an animal model of Parkinson’s disease.

Proclara recently completed a Phase 1a single-dose safety study of NPT088 in 40 healthy volunteers. In this study, NPT088 was safe and well-tolerated at multiple dose levels, with a suitable pharmacokinetic profile.

The Phase 1b trial announced today 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 characteristics, as measured by Aβ and tau PET imaging. Successful completion of the Phase 1b trial is expected to support Phase 2/3 development programs for Alzheimer’s disease, as well as for Parkinson’s disease.

About Proclara Biosciences

Proclara Biosciences is a biotechnology company advancing product candidates developed based on proprietary GAIM technology, which is capable of simultaneously targeting multiple toxic misfolded proteins. The broad applicability of the Proclara technology enables the company to target multiple protein misfolding diseases, including neurodegenerative diseases and several rare systemic amyloidoses. The lead GAIM drug candidate, NPT088, is in clinical development for the treatment of Alzheimer’s disease.

SOURCE: Proclara Biosciences

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