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 

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