Keystone Bio
Keystone Bio is seeking to diagnose, treat, modify, and prevent inflammation-driven diseases including early Alzheimer’s and Cardio-metabolic diseases.
[ORIGINALLY APPEARED IN MDNEXT Q4-2022]
Two of the most important and unmet disease processes in medicine are those driven by inflammation/NLRP3 (cardiovascular, stroke, cardio metabolics/type 2 diabetes and NASH) and pre- to early-dementia including Alzheimer’s. Importantly these two conditions (and others) are linked. Chronic inflammation has been shown to be the root cause of many neurodegenerative and vascular diseases affecting hundreds of millions of people.
Keystone Bio has developed a monoclonal antibody that can eradicate virulent Porphyromonas gingivalis (vPg), a chronic biofilm bacterial infection in the mouth that releases toxins throughout the body, both triggering and driving inflammation pathways that promote disease progression. The monoclonal antibody is deployed as a simple non-toxic solution every 6-12 months akin to fluoride treatments, and has been shown to prevent recolonization of vPG films at the source.
vPg is a serious, undiagnosable, currently untreatable, toxin-secreting bacterial infection in the oral cavity that drives all major systemic inflammatory pathways in the body leading to multi-end organ disease. The flow of toxins trigger, disarm, and overexpress the host’s innate immune response locally and systemically, activating pro-inflammatory NLRP1/3 inflammasomes and dysregulating the acquired immune system leading to the progression of many systemic diseases.
Their proprietary research has provided strong and convincing evidence of both the etiologic agent vPg and mechanisms of action for the neuro-inflammatory/degenerative disease in AD (Nara et. a. JADAIl 2021). Further the source DNA residing in AD brains is insufficient to account for the florid amounts of bacterial virulence factors present (Nara et. Al 2021). This work sheds new light on the longstanding conundrum of how the vPg bacteria/pathogen from a peripheral location (the oral cavity) is playing a direct/indirect systemic role in the pathogenesis of neuro-inflammation and Alzheimer’s disease—especially the inflammation, integrity losses and the eventual degeneration of the Brain Blood Barrier (BBB.)
By stopping the regular flow of the virulent factors and disease-causing toxins from the mouth throughout the body Keystone Bio is seeking to diagnose, treat, modify, and prevent inflammation-driven diseases including early Alzheimer’s and Cardio-metabolic diseases. Company Management is continuing pre-clinical and clinical development of a companion diagnostic (CDx) and precision Bio- therapeutic for the early to late treatment of this major driver of systemic inflammation in the human body.
In 2023 management expects to complete Phase 1a/b clinical trials, produce the cGMP clinical drug substance for the Phase 2/ab trials, leading to preIND and crucial pathway development/meetings. The company is currently seeking investment to further support the AUS and US Phase 2a/b clinical trial, FDA IND package and clinical studies. Primary US Phase 2 clinical trial support study sites are also being considered including Forsyth in Boston.
