Program pipeline

ONE PLATFORM.
MULTIPLE POSSIBILITIES.

Protego-PD leads our work in regenerative biotherapeutics, beginning with premature infants.

Lead investigational candidate

PROTEGO-PD

A human placental extract candidate being developed for the prevention of necrotizing enterocolitis and to support immature digestive development.

Preclinical evidence · Clinical development preparation

FDA orphan drug and rare pediatric disease designations are development designations, not marketing approval.

Understand the platform
Official Plakous Protego-PD investigational product rendering
The development path

EVIDENCE FIRST.
PROGRESS WITH PURPOSE.

01 / Evidence

Preclinical models

Company-reported work shows reductions in NEC disease severity and affected gut regions. HPE has also shown increased weight gain in models of extreme prematurity.

02 / Development

Clinical preparation

Plakous has described preparation for first-in-human clinical work. This is distinct from evidence of clinical efficacy or a confirmed recruiting trial.

03 / Future

Human evaluation

Clinical studies are needed to evaluate human safety and efficacy. Future milestones depend on study execution and regulatory review.

View the company’s published development timelinePlakous’s published 2026 development timeline; planned milestones are not confirmed completion dates

Company-published planning timeline. Dates represent targets and must not be interpreted as completed milestones.

Exploratory programs

THE HORIZON
BEYOND NEC.

Potential future targets identified by Plakous. These are exploratory areas, not approved indications.

Pediatric malabsorption

Supporting immature digestive development is an initial research focus alongside NEC prevention.

Neurodevelopmental injury

Exploring the relationship between inflammation and brain development in premature infants.

Bronchopulmonary dysplasia

Investigating the potential of regenerative biotherapeutics for inflammation-associated lung injury.

Acute respiratory distress syndrome

A potential future focus on inflammation and injury in adult lungs.

Neurodegenerative diseases

Exploratory research into inflammatory mechanisms in Alzheimer’s disease, ALS and Parkinson’s disease.

Osteoarthritis

Company-reported preclinical work examines protection of joint cartilage.

Source material

HPE value, preclinical evidence and timelineFuture clinical targets and references
A shared purpose

LET’S MOVE
SCIENCE FORWARD.

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