P4M01—The antimicrobial peptide

Gingivitis treatment progressing towards commercialization, leading our pipeline

 P4 Microbiome is developing antimicrobial peptide-based therapies for a range of dysbiosis driven conditions

IBS = Irritable Bowel Syndrome; SIBO = Small Intestinal Bacterial Overgrowth

Preparing for pre-IND meeting with FDA

Program highlights to date

Completed Phase IIa showing statistically significant reduction in plaque vs placebo at 4 days with a 9x greater reduction in plaque than placebo.

  • Analogous studies of Listerine showed 1.5x reduction in plaque vs placebo by 14 days

  • Completed 28-day toxicology with no identified safety signals

Completed Phase I, instructive on dose: Demonstrated significant plaque reduction in <14 days.

  • Demonstrated significant gingivitis reduction at 14 days despite being a chronic condition that typically requires >6-month study to demonstrate efficacy

Completed CMC drug substance/product and additional toxicological studies for late-2022 FDA pre-IND meeting for Phase IIb.

Why chewing gum?

The majority of dental providers surveyed strongly agreed that anti-gingivitis chewing gum would be welcome in a disease category that needs new treatment options.

A survey of 237 high-volume dental providers found:

92%

see a role for anti-gingivitis chewing gum in a broad range of patients

86%

strongly agree or agree that new gingivitis treatments are needed

65%

had high or very high interest in the anti-gingivitis chewing gum profile, especially dentists and hygienists (likely due to severity of cases seen in that setting)

53%

say that chewing gum is an exciting treatment option due to anticipated patient acceptance and convenience

P4M01 in brief

P4M01 is an antiplaque chewing gum containing the synthetic antimicrobial peptide known as KSL-W developed by the US Army (Dental and Trauma Research Detachment, now part of the Army Institute of Surgical Research).

 P4M01 is well-suited for oral use because it:

  • Selectively inhibits growth of oral bacteria associated with plaque development but maintains healthy flora

  •  Demonstrated good stability in saliva while quickly degrading in the stomach, confirming that it does not cause any harm to intestinal flora or has systemic risks

The US Army developed PM401 up to Phase 1 and small-scale Phase 2 studies in the US, confirming its safety and efficacy against dental plaque formation. In 2020, P4 Microbiome obtained an exclusive license to develop and commercialize KSL-W for treatment of periodontal disease.

Developing antimicrobial peptides for a wide variety of dysbiosis-driven diseases

We have completed pre-clinical toxicology studies, pursuant to developing antimicrobial peptide-based therapies for:

  • Irritable Bowel Syndrome (IBS)

  • Small Intestinal Bacterial Overgrowth (SIBO)

 

This product is neither FDA-approved nor offered for sale to individuals at this time. The product will not be offered for sale until P4 Microbiome receives authorization from the FDA to do so. The statements made by P4 Microbiome are based on clinical trial observations. The safety and efficacy profile of the product is still being evaluated by P4 Microbiome and the FDA.