Creating an antimicrobial peptide therapeutic for gingivitis
HALF of American adults suffer from gum disease
have periodontitis
47.2%
have moderate periodontitis
30.0%
8.5%
have severe periodontitis
Gingivitis is a very large, untapped market*
Prevents the formation of biofilm on the teeth
Suppresses oral microbial growth and reduces plaque formation
Published in Pharmaceutical Research (2007)
P4M01—an antimicrobial peptide
The US Army developed KSL-W (P4M01) up to the Ph IIa clinical trials in the US, then granted an exclusive license to P4 Microbiome for further development in February of 2020.
Clinical development history
The US Army Dental and Trauma Research Detachment (USADTRD) found that synthetic KSL decapeptide may be a useful antimicrobial agent for inhibiting growth of oral bacteria associated with dental caries and early plaque. Then:
KSL-W (P4M01), an L-tryptophan analog of KSL, was selected as the most promising candidate with excellent balance of therapeutic activity, stability and safety
USADTRD formulated a chewing gum (Platak™) for effective, sustained and improved antiplaque delivery in the mouth
PM401 clinical profile
A powerful dental antimicrobial peptide for oral hygiene
Selective bactericidal activity against supragingival plaque bacteria while sparing beneficial oral flora
Good balance of therapeutic activity and safety
Inhibits growth of oral bacteria associated with plaque
Good stability in saliva and rapid degradation in stomach without systemic exposure or harm to intestinal flora
Sustained delivery as chewing gum
Readily absorbed by tooth-like materials and effectively desorbs over time
Demonstrated clinical efficacy
Confirmed statistically significant reduction in plaque (ie, primary cause of periodontal disease) from the Phase