Keystone Bio Recognizes the Big "GAIN" from Cortexyme's Trial Results

GAIN Trial Results Confirm Relationship Between Porphyromonas Gingivalis (Pg) and Alzheimer’s Disease, and Furthers Keystone Bio’s Explanation of Pg’s Toxic Virulence Factors.

Key Takeaways from the GAIN Trial

Keystone Bio acknowledges Cortexyme's efforts in advancing Alzheimer’s disease research through its recently published Ph ll/lll GAIN Trial preliminary results.

Although the trial did not meet its endpoints, it demonstrated that reduction of Pg infection in the oral cavity results in slowing the progression of Alzheimer’s disease in individuals who are Pg positive (Pg+) in the mouth.

Pg from the mouth is a cause of some Alzheimer’s disease.

Keystone Bio has identified toxic proteins from Pg in many Alzheimer's disease brain tissues that are not supported by similar DNA brain tissue studies. Pg toxins leave the mouth, Pg's only major source, and have to cross the blood brain barrier into the brain, driving forms of early to late dementia including Alzheimer’s disease. These same Pg toxic proteins are reported in high levels in gingival crevicular fluid and can exist as soluble, free and immune complexed forms in the blood driving vascular inflammation and end organ disease.

Pg in the mouth, not the brain, is the key target.

Keystone Bio’s own research and disease model discussed how Pg colonizes the oral cavity and releases tissue-destroying toxic proteins locally and systemically into the bloodstream. The GAIN Trial results show that targeting Pg at its source (the mouth) should substantially improve cognitive decline and the progression of Alzheimer’s disease.

Keystone Bio is one step closer to connecting this oral driver of neuro-inflammation with the possibility of treating or preventing a major cause of early to late stage dementia and Alzheimer’s disease at its source

Keystone Bio is commercializing a new treatment strategy for diseases driven by Pg’s toxins at their source, the mouth. Keystone Bio’s PrevEvent™ treats Pg and all of its toxins, with the precision monoclonal antibody KB-001. KB-001 was shown in its first clinical trial to prevent recolonization of Pg for 9-12 months in the mouth.

From Keystone Bio CEO

From Keystone Bio’s perspective, the GAIN trial results are a positive advancement relating Pg's oral source and its removal to the prevention and ultimately the elimination of chronic inflammatory diseases.

- Dr. Daniel Sindelair, DMD, Keystone Bio’s chief executive officer.

Be Part of our Mission to Eliminate Pg and all of its Toxins

To discuss opportunities with Keystone Bio and for additional infomation on what the GAIN Trial results mean for Keystone Bio, contact us through the form below.

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