COYA 301 therapy shows ‘encouraging results’ for Alzheimer’s

No cognitive decline seen in 8 patients over 4-month treatment

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by Steve Bryson, PhD |

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“Encouraging results” were reported in eight Alzheimer’s disease patients with dementia who were treated with COYA 301, an experimental therapy being evaluated in a small clinical trial, according to Coya Therapeutics, its developer.

“Results of our open-label proof-of-concept study with COYA 301 in 8 patients with Alzheimer’s showed encouraging results,” Howard Berman, PhD, Coya’s CEO, said in an emailed statement to Alzheimer’s News Today. “Over the course of the 4-month treatment, the patients showed no cognitive decline with concomitant increase in the Treg function. Also, treatment with COYA 301 was well tolerated.”

Besides cognitive benefits, the immune-modulating therapy, given as an under-the-skin injection, increased the levels of regulatory T-cells (Tregs) as intended. Tregs are a subtype of immune T-cells that regulate and suppress immune and inflammatory responses.

“We believe the outcomes of this proof-of-concept study of COYA 301 in patients with AD [Alzheimer’s disease] are encouraging and we will continue to analyze the data to decide our next steps,” Adrian Hepner, MD, PhD, Coya’s president and chief medical officer, said in a company press release.

Findings were recently presented in a poster, titled “Regulatory T Cell Expansion Strategy to Target Inflammation in AD: Phase I feasibility trial,” at the Keystone Conference ‘Neurodegeneration: New Biology Guiding the Next Generation of Therapeutic Development’ in Canada.

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Alzheimer’s is leading cause of dementia

Alzheimer’s disease is the leading cause of dementia, a general term for memory loss and other cognitive impairments that interfere with daily life.

“Alzheimer’s disease (AD) is the most common form of dementia, impacting the lives of millions in the United States and worldwide,” Berman said. “My own grandmother and father passed away from dementia and so this is a fight that is personal to me.”

The disease is marked by the death of nerve cells caused by the buildup of toxic protein clumps, called amyloid plaques and tau tangles, in the brain. Besides toxic clumps, brain inflammation is thought to play a role in the severity and progression of the disease.

“While everyone has heard of the amyloid beta and tau drugs that are in development, inflammation is a novel and critical feature of AD pathogenesis [development],” Berman said. “Research studies have identified that inflammation of the brain plays an important role in the severity and progression of neurodegenerative diseases, including Alzheimer’s.”

“We believe that inflammation is critical for the onset and progression of AD and could provide a new focus for therapeutic intervention,” Berman said.

Alzheimer’s disease (AD) is the most common form of dementia, impacting the lives of millions in the United States and worldwide. My own grandmother and father passed away from dementia and so this is a fight that is personal to me.

In Alzheimer’s, the function of Tregs is compromised, with the immune system shifting toward a pro-inflammatory state.

“Regulatory T cells (Tregs) constitute a subset of T cells of the immune system that play a neuroprotective role by suppressing inflammation in the blood and in the brain,” Berman said. “Our scientists were among the first to document that Tregs are compromised in AD patients and that decreased function of Tregs in these patients is often present.”

Interleukin-2 (IL-2) is an immune signaling protein that promotes immune tolerance by stimulating and maintaining Tregs. COYA 301 is a low-dose formulation of IL-2 that is designed to enhance the function and expand the number of Tregs, with the goal of easing inflammation and slowing disease progression.

Conducted at Houston Methodist Hospital, in Texas, the now-complete Phase 1 study (NCT05821153) tested COYA 301 in eight Alzheimer’s patients with dementia, as assessed by the Mini-Mental State Examination (MMSE). The study was open-label, meaning that both providers and participants were aware of the treatment being given.

Participants received a monthly five-day course of COYA 301 for four months. After that, they were followed for an additional period of two months.

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COYA 301 led to improvement in test scores

COYA 301 resulted in a statistically significant improvement in mean MMSE scores on days 30, 60, and 90 during the treatment phase. MMSE scores were comparable to those seen at baseline (before starting treatment) on days 120 and 168.

Consistently, scores on the Clinical Dementia Rating-Sum of Boxes, a measure of cognitive functioning, showed a trend toward improvement on day 120, which reverted back toward pre-treatment scores by day 168.

In other cognitive measures, scores from the Alzheimer’s Disease Assessment Scale-Cognitive Subscale remained stable throughout treatment and follow-up, altogether indicating the absence of cognitive decline.

By the end of the treatment period, the mean percentage of Tregs nearly doubled compared with baseline levels (8.68 vs. 4.55). Likewise, mean Treg suppressive function significantly increased with treatment (79.5 % vs. 46.61%). COYA 301 also significantly lowered the levels of several pro-inflammatory immune signaling molecules in the patients’ bloodstream following each treatment cycle.

The investigational therapy was well-tolerated, with mild injection-site reactions and mild leukopenia (low white blood cell counts) being the most common adverse events. No serious adverse events were noted, and there were no study discontinuations.

Coya is also developing a similar therapy, called COYA 302, for amyotrophic lateral sclerosis (ALS), a neurodegenerative disease that affects muscles. The IL-2-based treatment is designed to increase Treg activity while decreasing the activity of pro-inflammatory immune cells. Early data showed COYA 302 was able to slow disease progression in four ALS patients.

“We continue reviewing the data and evaluating next steps,” Berman said. “The data in Alzheimer’s patients supports our Treg-focused approach for the treatment of neurodegenerative diseases of high unmet need, similarly to the recent data from COYA 302 in ALS.”

The study was sponsored by Coya with support from the Alzheimer’s Association Part-the-Cloud Award.