# Product optimization to commercialize an oral bacteriophage cocktail that prevents cholera in real-world settings

> **NIH NIH R44** · PHAGEPRO, INC. · 2021 · $999,585

## Abstract

Project Summary
 Cholera is an acute and severe disease caused by the bacterium Vibrio cholerae that is spread primarily
through contaminated water sources due to a lack of adequate sanitation infrastructure. The World Health
Organization estimates that there are at least 3 million cases globally per year, 40 percent of which are spread
through household transmission. Current prevention methods, such as the oral cholera vaccine (OCV) and water,
sanitation, and hygiene (WASH) campaigns, require significant investment of resources and time for efficacy,
but household contacts of cholera patients often present with cholera symptoms two to three days after the initial
patient becomes sick. In addition, the preventive use of antibiotics is not recommended due to widespread
resistance and the known negative consequences of dysbiosis. There is a pressing need to develop a targeted
clinical intervention to prevent the community spread of cholera using a rapid prophylactic treatment. PhagePro
aims to fill this gap with its first product ProphaLytic-VcTM (PVC). PVC is an orally administered bacteriophage
(phage) cocktail comprised of Vibriophages ICP1, ICP2, and ICP3.
 In this Phase II SBIR proposal, we aim to further develop PVC for deployment in real-world settings as part
of a cholera toolkit that includes WASH and OCV campaigns. First, we aim to test co-administration of PVC with
the OCV, particularly as the WHO Global Task Force on Cholera Control (GTFCC) recommends that National
Cholera Control Plans (NCCP) move towards integration of services to reduce logistical burden and costs. In
addition, the majority of interviewed stakeholders stated that a holistic approach is critical to cholera control.
Second, we have identified that cold chain dependence is a major contributor to OCV campaign costs. Therefore,
we aim to build upon our Phase I STTR success to develop PVC in a solid dosage formulation. This will increase
the stability of PVC in hot and humid environments, enabling Ministries of Health to stockpile PVC in-country and
distribute to identified cholera hotspots without the use of the cold chain. This mechanism will increase timeliness
of the cholera outbreak response, which has been identified as the key factor in controlling an outbreak in both
endemic and non-endemic settings. Third, we aim to optimize phage ratios in PVC to most effectively kill
circulating strains of V. cholerae. We will collect 96 clinical isolates from recent epidemics in South Asia and
Africa in the past 3 years to determine host range coverage. Additionally, we will optimize the ratio of phages on
2 representative clinical isolates to best reduce V. cholerae colonization in mice. Lastly, we will establish a post-
exposure, pre-symptomatic rabbit model to better simulate clinical settings for the HCs during the high-risk period
and demonstrate that PVC can effectively prevent the onset of symptoms.
 At the successful conclusion of Phase II, we will have a solid dosage f...

## Key facts

- **NIH application ID:** 10147193
- **Project number:** 2R44AI142960-03
- **Recipient organization:** PHAGEPRO, INC.
- **Principal Investigator:** Andrew Camilli
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $999,585
- **Award type:** 2
- **Project period:** 2018-12-15 → 2024-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10147193

## Citation

> US National Institutes of Health, RePORTER application 10147193, Product optimization to commercialize an oral bacteriophage cocktail that prevents cholera in real-world settings (2R44AI142960-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10147193. Licensed CC0.

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