TriCelX Takes On Alzheimer’s — Its Third Brain Disease, and the Largest

FRISCO, TX, UNITED STATES, October 21, 2026 /EINPresswire.com/ -- TriCelX, Inc. today announced that it filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration to test XytriX™, its investigational biotherapeutic made from signaling cells found in donated umbilical cord tissue, in people with mild Alzheimer's disease. The company also requested Fast Track designation, which has not been granted. Three of its four FDA programs are now aimed at diseases that destroy the brain.

The largest of them all
The Alzheimer's Association estimates that 7.4 million Americans aged 65 and older have Alzheimer's. Care for people with Alzheimer's and other dementias will cost $409 billion this year, most of it paid by Medicare and Medicaid, and is heading toward $1 trillion a year by mid-century. Nearly 13 million family members and friends gave more than 19 billion hours of unpaid care last year. Worldwide, according to the World Health Organization, 57 million people were living with dementia in 2021, and about 10 million more develop it every year.

And almost nothing slows it
The two newer drugs that clear amyloid slow decline modestly, are given by infusion at least to start, require repeated MRI scans, and carry the FDA's strongest warning for brain swelling and bleeding. Many patients cannot take them, and Medicare's forecasts project little spending on them through 2027.

"For decades, brain medicine has looked through a keyhole — one protein, one target, one disease," said Jakes Jordaan, Founder, President and CEO of TriCelX. "In Alzheimer's, 99.6 percent of the drugs tested between 2002 and 2012 failed. Not for lack of brilliant people, but because most were aimed at a single protein in a disease that runs through the whole network, and most arrived years after the damage had begun. We are looking at the whole sky: a galaxy of signals running between neurons, immune cells, blood vessels and the rest of the body."

The approach, in brief
Alzheimer's is not one broken part. It is an ecosystem that has lost its balance: immune cells that will not stand down, support cells that turn hostile, blood vessels that leak, signals from the body that keep feeding the fire, and neurons and synapses caught in the middle. The result is chronic neuroinflammation — a self-reinforcing loop in which each failure feeds the next. Instead of one molecule aimed at one protein, XytriX™ is made of living signaling cells proposed to sense and respond to many parts of that loop at once. Instead of waiting, the study enrolls people at the mild stage. Instead of one route that cannot get past the brain's barrier, it tests two: into a vein, and as drops in the nose.

Where memories live
The human brain holds about 86 billion neurons joined by some 100 trillion connections, called synapses — more than there are stars in our galaxy. A memory lives not in any one cell but in the pattern of those connections: a wedding day, a child's voice, the way home. Long before neurons die, synapses begin to fail, and synapse loss tracks cognitive decline more closely than anything else pathologists can see under the microscope.

Why the proteins build up
Amyloid is a small protein fragment the brain makes every day as part of ordinary synaptic work and normally clears, with clearance appearing to rise during sleep. The trouble starts when they stick together, first into small clumps that appear to be most damaging to synapses, then into the larger deposits called plaques.

In the common late-onset form, research suggests the problem is not that production rises but that clearance slows. One of the brain's main cleanup crews is its own immune cells, the microglia. Stuck in a long-running inflammatory state, they clear less and inflame more, and in mouse studies they begin removing synapses as well. As clearance falls behind, amyloid builds into plaques; tau, the second protein, twists into tangles inside neurons and appears to spread from cell to cell. At the same time the barrier that seals the brain off from the blood starts to leak in the memory center, early, and worst in carriers of the APOE4 risk gene.

Microglia: the brain's own immune system. About one brain cell in ten is a microglial cell. In a healthy brain they are part security guard, part gardener: clearing debris and amyloid, fighting infection, and trimming connections that are not being used. In Alzheimer's, they appear to get stuck in the "on" position — sending out inflammatory signals, clearing less, and turning against the connections they once tended. Many of the genes that raise a person's risk of Alzheimer's act in microglia. Calming them, without switching them off, is the main effect XytriX™ is being studied for.

Astrocytes: the brain's caretakers. A single human astrocyte can touch up to two million synapses. Astrocytes feed neurons, mop up chemical messengers, help form new connections, and wrap the brain's blood vessels, forming part of the barrier. In Alzheimer's, signals from overactive microglia can switch astrocytes into a reactive state in which they stop caring for neurons and, in laboratory studies, begin to harm them. A protein that rises when they turn reactive, GFAP, can be measured in blood, and the study tracks it.

Different proteins, the same fire
CTE has tau. Most ALS involves TDP-43. Alzheimer's has amyloid and tau. Around each, the immune system switches on and stays on. The proteins are the fuel; the inflammation is the fire. XytriX™ is not designed to remove the fuel. It is being studied for its effect on the fire.

Cells that sense, decide and respond
A conventional drug is a switch: one molecule, one target, the same action wherever it lands. A signaling cell works more like a search. Each one samples the chemical signals around it — inflammatory messengers, oxygen levels, signs of injury — weighs them, and adjusts what it releases in response. In laboratory studies, scientists call one version of this "licensing": the more inflammation the cells detect, the more strongly they switch on their calming program. Signaling cells from umbilical cord tissue have been shown in the laboratory to release hundreds of different proteins, plus tiny packages called exosomes carrying their own cargo, and to change the mix as conditions change. Not intelligence in the human sense, but biological intelligence: the capacity to read a complex situation and respond to it, far closer to an adaptive search than to a switch.

In TriCelX's working model, what the cells release is proposed to work on four fronts at once. Immune modulation:calming the overactive immune response in the brain and the body. Neurotrophic support: feeding neurons that are damaged but still alive, and the synapses that hold memory. Blood-vessel support: helping the small vessels, the barrier around them and the blood supply the brain depends on. Anti-scarring, the least tested of the four in the brain: limiting the scar-like response that builds up around injured cells and vessels. In the brain the cells are not designed to become neurons or to replace anything.

Ecologists call a change that ripples through every level of an ecosystem a trophic cascade. Alzheimer's looks like one running in the wrong direction: immune signals tip the microglia; the microglia tip the astrocytes; reactive astrocytes and leaking vessels stop nourishing neurons; and the synapses fail before the neurons themselves are lost. The aim of XytriX™ is to start a cascade in the other direction, with the brain's own cells passing changed signals on to their neighbors, helping the tissue return to balance — the state doctors call homeostasis.

Two ways in
Into a vein, XytriX™ is proposed to act mainly through the immune system and the signals it releases into the blood, which can reach the parts of the brain where the barrier has begun to leak. As drops onto the lining of the nose, it may take a shorter path: the nerves of smell pass through a thin, sieve-like plate of bone straight to the underside of the brain without a needle in the spine. How much reaches the adult brain has not been measured.

"Everything that makes a person who they are lives in those hundred trillion connections — the names of their children, the story of their marriage, the way they laugh," said Mr. Jordaan. "Alzheimer's takes them one connection at a time. We are not chasing a protein. We are going after the state the brain is in. We do not know yet whether XytriX™ can change that. This study is how we find out, and we will report what we find either way."

The study
Nine people with mild Alzheimer's, in three groups — vein, nose, or both — and possibly up to eighteen. Three treatments, four weeks apart, then two years of follow-up. No placebo: everyone receives XytriX™. An FDA-cleared blood test is used instead of a PET scan to confirm the amyloid buildup that defines the disease, and people on blood thinners can take part. The first goal is safety; the study also tracks memory, daily function and an MRI measure linked to brain inflammation. It runs at the Baylor Scott & White Sports Therapy & Research Center in Frisco, led by Dr. Abdul Baker, a board-certified neurosurgeon and TriCelX's Chief Medical and Scientific Officer, under an independent safety board.

One fact TriCelX puts up front: as of the October 21 filing, XytriX™ had been given to people in clinical studies only by injection into the knee. These studies may be the first time it is given into a vein or through the nose in a clinical study. So the first person in the nasal group starts at half the dose, and each group's first participant is treated alone and watched through a full four-week cycle, with the independent safety board reviewing that cycle before anyone else in the group is treated.

Another company's cells, from adult bone marrow, have been tested by infusion in a placebo-controlled study in which 49 people with mild Alzheimer's were treated. The study met its safety goal, and later analyses, not yet peer reviewed, reported lower values on an MRI measure linked to brain inflammation. TriCelX claims none of those results for XytriX™.

"Alzheimer's is not a single attack. It is a cascade across the whole neural network — immune cells, support cells, blood vessels and the synapses between neurons — and a single-target drug meets it at one point," said Dr. Baker, the study's lead investigator. "Signaling cells are proposed to meet it as a network. They are not designed to replace neurons or to go after amyloid. The question is whether they can calm the immune response, support the neurons that are still working and help the brain find its balance again. Our knee study is giving us the first human experience with XytriX™, and that is where our first results will come from."

One architecture, not four bets
TriCelX is building one biotherapeutic, aimed at the signaling between the brain, its blood vessels and the body's immune system, developed across diseases at once.

ALS shows how the pieces fit. The FDA cleared TriCelX's ALS study in September. It uses the same cells, made from the same cell banks to the same standards, and the same two routes — a vein and the nose — as the Alzheimer's study. The failure it is being studied against is similar: lost connections. In ALS, evidence suggests the first connections to fail are between nerve and muscle; in Alzheimer's, between neurons in the memory center. Different address, same failure.

Together, the four programs form a single development path. CTE, ALS and Alzheimer's test the same signaling approach in three brain diseases, and one nasal method is developed once and shared between the ALS and Alzheimer's studies. Manufacturing, safety and delivery experience builds across the programs. Each disease must still produce its own evidence of whether XytriX™ works.

"If we are right, one biotherapeutic can be tested against brain diseases that have so far been fought one at a time," said Mr. Jordaan. "If we are wrong, we will say so. Alzheimer's has defeated companies with far deeper pockets than ours. We are not claiming to have solved anything. We are telling you who is still in the fight."

Four applications since March
This is TriCelX's fourth FDA application since March, all for the same biotherapeutic, made in its own cGMP, FDA-registered facility in Frisco. The first three have been cleared to proceed: knee osteoarthritis (April), CTE (June) and ALS (September). TriCelX has also asked the FDA to designate XytriX™ as an orphan drug for ALS, a status that brings development incentives; that request has not been granted.

The first human information is coming from the knee, and the knee is not as far from the brain as it sounds. Osteoarthritis increasingly appears to involve persistent low-grade inflammation of the joint lining, which contributes to cartilage breakdown. Same cells, same proposed mechanism, different tissue. Participants in the knee study have been treated and are being followed, and TriCelX expects to report initial results from the study's first cohort before the end of 2026. Those results will concern the knee, not the brain, and will not show whether XytriX™ works in any brain disease.

About XytriX™
XytriX™ is TriCelX's investigational biotherapeutic made from mesenchymal signaling cells (hUC-MSC) found in donated umbilical cord tissue, produced at the company's cGMP, FDA-registered facility in Frisco, Texas.

About TriCelX, Inc.
TriCelX, Inc. is a vertically integrated, clinical-stage allogeneic biotherapeutics company headquartered in Frisco, Texas. In its own cGMP, FDA-registered facility, the company turns a single donated umbilical cord into six biotherapeutics developed along separate regulatory paths. Learn more at www.tricelx.com.

XytriX™ is an investigational biotherapeutic that has not been approved by the U.S. Food and Drug Administration. Fast Track designation has been requested and has not been granted. XytriX™ has not been shown to be safe or effective in Alzheimer's disease or any other condition. Statements about how XytriX™ is proposed to work describe the company's scientific working model, not established fact. For Alzheimer's disease, XytriX™ is available only within the clinical study described above. The science and sources behind this release are set out in full in the accompanying scientific brief. None of the organizations cited has reviewed or endorsed this release.

Kathryn Dziedzic
TriCelX
+1 970-305-1165
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