Programs
Our clinical programs
All four programs study the same investigational biotherapeutic, XytriX™, under the oversight of the U.S. Food and Drug Administration.
Pipeline
| Program | Route | IND | Phase 1/2 | Phase 3 |
|---|---|---|---|---|
| Knee OsteoarthritisLead Program | Into the joint |
FDA-cleared IND |
Phase 1/2 study |
|
| Chronic Traumatic Encephalopathy | IV + intrathecal |
FDA-cleared IND |
||
| ALS | IV + intranasal |
FDA-cleared IND |
||
| Alzheimer’s Disease | IV + intranasal |
IND filed |
Lead Program
Knee Osteoarthritis
Status: FDA-cleared IND. Phase 1/2 study.
Osteoarthritis is not just wear and tear. Worn cartilage sheds fragments, the joint lining treats them as a threat, and the resulting inflammation wears down more cartilage, driving pain and stiffness. XytriX is designed to calm the joint lining, protect remaining cartilage and support repair. It is delivered by injection directly into the knee.
The problem
The disease
Osteoarthritis is the world’s most common joint disease and a leading cause of disability and chronic pain. In the knee, inflammation of the joint lining and cartilage breakdown feed each other.
The scale
More than 500 million people worldwide and one in seven American adults. More than $137 billion a year in U.S. costs.
Today’s care
Pain relief and steroid injections manage symptoms at best, and steroids carry risks including cartilage damage and faster joint destruction. No disease-modifying therapy is approved.
Chronic Traumatic Encephalopathy (CTE)
Status: FDA-cleared IND.
CTE is linked to years of repeated head impacts. The brain's immune cells can remain activated for decades and its blood vessels stay leaky, keeping inflammation going long after the last impact. XytriX is designed to switch off that persistent response and help restore the brain's protective barrier. It is being studied intravenously and intrathecally.
The problem
The disease
A progressive, fatal brain disease caused by repeated head impacts and blast exposure. It moves through memory loss, behavioral and psychiatric change, and dementia, often in mid-life. Today it can only be confirmed after death.
The scale
CTE was found in 110 of 111 former NFL players’ brains studied, and in at least one in four of all former players who died from 2016 to 2021. About 500,000 U.S. service members were diagnosed with brain injury from 2000 to 2023, most from blast, and much of that blast exposure happens in training.
Today’s care
There is no FDA-approved treatment of any kind, no disease-modifying therapy and no accepted way to slow progression. Families are told to manage the decline.
The federal mandate. The Blast Overpressure Safety Act (December 2024) made blast-related brain injury a federal responsibility, requiring career-long brain-health monitoring and blast-exposure tracking for service members. Monitoring detects the problem; it does not yet come with a treatment.
Amyotrophic Lateral Sclerosis (ALS)
Status: FDA-cleared IND.
In ALS the nerves that control muscle progressively die. Research has linked falling numbers of peacekeeper immune cells with faster progression. XytriX is designed to help restore those cells and supply survival signals to motor neurons. It is being studied intravenously and intranasally.
The problem
The disease
ALS destroys the motor neurons that control movement, speech, swallowing and, finally, breathing. Most people live two to five years after symptoms start.
The scale
About 30,000 Americans live with ALS. Former NFL players die of it at more than four times the expected rate, and veterans develop it at higher rates than civilians; the VA treats ALS as service-connected.
Today’s care
Since the first ALS drug was approved more than 30 years ago, the treatments available slow decline modestly. None stops or reverses it.
Alzheimer's Disease
Status: IND filed.
In Alzheimer's, protein deposits trigger the brain's immune cells into a chronic attack mode that damages the connections between brain cells. XytriX is designed to return those cells to their cleanup role and to protect the connections that support memory. It is being studied intravenously and intranasally.
The problem
The disease
Alzheimer’s destroys memory by breaking the connections between brain cells, long before the cells themselves die. It is the most common cause of dementia.
The scale
7.4 million Americans aged 65 and older. 57 million people worldwide live with dementia, with about 10 million new cases a year. Dementia care costs $409 billion this year and is heading toward $1 trillion a year by mid-century.
Today’s care
Two newer drugs that clear amyloid slow decline modestly, require infusions and repeated MRI scans, and carry the FDA’s strongest warning for brain swelling and bleeding. Many patients cannot take them. Of the drugs tested from 2002 to 2012, 99.6 percent failed.
XytriX is investigational and has not been approved by the FDA. Its safety and effectiveness have not been established.